We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy, Tolerability, and Pharmacokinetics of Multiple Doses of Oral TAK-831 in Adults With Friedreich Ataxia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03214588
Recruitment Status : Completed
First Posted : July 11, 2017
Results First Posted : December 19, 2019
Last Update Posted : June 14, 2021
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
Neurocrine Biosciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Friedreich Ataxia
Interventions Drug: TAK-831
Drug: TAK-831 Placebo
Enrollment 67
Recruitment Details Participants took part in the study at 6 investigative sites in the United States from 08 November 2017 to 27 December 2018.
Pre-assignment Details Participants with a diagnosis of Friedreich Ataxia were randomized in a 2:1:2 ratio to receive TAK-831 75 mg TAK-831 300 mg or TAK-831 placebo-matching tablets twice daily.
Arm/Group Title Placebo TAK-831 75 mg TAK-831 300 mg
Hide Arm/Group Description TAK-831 placebo-matching tablets, orally, twice daily for up to 12 weeks. TAK-831 75 mg, tablets, orally, twice daily for up to 12 weeks. TAK-831 300 mg, tablets, orally, twice daily for up to 12 weeks.
Period Title: Overall Study
Started 27 14 26
Completed 26 13 24
Not Completed 1 1 2
Reason Not Completed
Adverse Event             1             0             2
Reason Not Specified             0             1             0
Arm/Group Title Placebo TAK-831 75 mg TAK-831 300 mg Total
Hide Arm/Group Description TAK-831 placebo-matching tablets, orally, twice daily for up to 12 weeks. TAK-831 75 mg, tablets, orally, twice daily for up to 12 weeks. TAK-831 300 mg, tablets, orally, twice daily for up to 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 27 14 26 67
Hide Baseline Analysis Population Description
Full analysis set (FAS) included all randomized participants who received at least 1 dose of the study drug for the treatment period.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants 14 participants 26 participants 67 participants
32.5  (11.01) 31.1  (11.28) 29.6  (8.92) 31.1  (10.23)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 14 participants 26 participants 67 participants
Female
17
  63.0%
5
  35.7%
15
  57.7%
37
  55.2%
Male
10
  37.0%
9
  64.3%
11
  42.3%
30
  44.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 14 participants 26 participants 67 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
27
 100.0%
13
  92.9%
26
 100.0%
66
  98.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   7.1%
0
   0.0%
1
   1.5%
Body Mass Index (BMI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 27 participants 14 participants 26 participants 67 participants
24.89  (4.920) 24.94  (4.400) 23.02  (3.862) 24.18  (4.456)
[1]
Measure Description: Body Mass Index = weight(kg)/[height(m)^2]
Average Inverse Time to Complete 9-hole peg test (9-HPT-1)   [1] 
Median (Full Range)
Unit of measure:  1/seconds
 Number Analyzed 27 participants 14 participants 26 participants 67 participants
First Assessment
0.01740
(0.0055 to 0.0298)
0.01660
(0.0062 to 0.0278)
0.01575
(0.0075 to 0.0404)
0.01680
(0.0055 to 0.0404)
Second Assessment
0.01710
(0.0082 to 0.0254)
0.01605
(0.0073 to 0.0269)
0.01595
(0.0067 to 0.0391)
0.01660
(0.0067 to 0.0391)
[1]
Measure Description: The inverse of the time to complete the 9-hole peg test (9-HPT-1), defined as 1/(time to complete the 9-hole peg test), is summarized.
1.Primary Outcome
Title Change From Baseline in the Inverse Time to Complete the 9-Hole Peg Test (9-HPT-1)
Hide Description The 9-HPT-1 is a measure of timed upper extremity (arm and hand) function and manual dexterity. The participant picks up pegs 1 at a time (9 in total), using 1 hand only, and places them into holes on the board as quickly as possible, in any order until all holes are filled. Then, without pausing, the participant removes the pegs 1 at a time and returns them as quickly as possible. Each participant performs this task twice with each hand separately. Results on both tests are then averaged for an overall task completion time and the inverse transform is performed. A positive change from Baseline indicates improvement. Change from Baseline in 9-HPT-1 was analyzed using mixed model for repeated measures (MMRM) analysis of covariance (ANCOVA) with Baseline 9-HPT-1 as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline 9-HPT-1-by-visit interactions.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point.
Arm/Group Title Placebo TAK-831 75 mg TAK-831 300 mg
Hide Arm/Group Description:
TAK-831 placebo-matching tablets, orally, twice daily for up to 12 weeks.
TAK-831 75 mg, tablets, orally, twice daily for up to 12 weeks.
TAK-831 300 mg, tablets, orally, twice daily for up to 12 weeks.
Overall Number of Participants Analyzed 24 12 24
Least Squares Mean (Standard Error)
Unit of Measure: 1/seconds
0.00038  (0.000448) -0.00017  (0.000622) -0.00032  (0.000445)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 75 mg
Comments Change from Baseline at Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.999
Comments P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.00054
Confidence Interval (2-Sided) 90%
-0.00179 to 0.00070
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.000746
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 300 mg
Comments Change from Baseline at Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.999
Comments P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.00069
Confidence Interval (2-Sided) 90%
-0.00172 to 0.00033
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.000616
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in the Activities of Daily Living (ADL) Component Score of the Friedreich Ataxia Rating Scale (FARS)
Hide Description The ADL component of the FARS includes 9 subscales: speech, swallowing, cutting food and handling utensils, dressing, personal hygiene, falling, walking, quality of sitting position, and bladder function. Each of these subscales is rated on a 5-point scale where 0=normal to 4=severe disability/inability to carry out activity independently for a total possible score of 0 to 36, with higher scores representing greater disability/dependency. A negative change from Baseline indicates improvement. Change from Baseline in FARS ADL upper limb function items were analyzed using MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.
Time Frame Baseline and Weeks 2, 7 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point.
Arm/Group Title Placebo TAK-831 75 mg TAK-831 300 mg
Hide Arm/Group Description:
TAK-831 placebo-matching tablets, orally, twice daily for up to 12 weeks.
TAK-831 75 mg, tablets, orally, twice daily for up to 12 weeks.
TAK-831 300 mg, tablets, orally, twice daily for up to 12 weeks.
Overall Number of Participants Analyzed 27 14 26
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
Change from Baseline at Week 2 Number Analyzed 27 participants 13 participants 26 participants
-0.25  (0.468) -1.12  (0.665) 0.34  (0.463)
Change from Baseline at Week 7 Number Analyzed 26 participants 13 participants 24 participants
-0.33  (0.465) -0.15  (0.655) 0.03  (0.467)
Change from Baseline at Week 12 Number Analyzed 24 participants 12 participants 24 participants
-0.61  (0.493) -0.37  (0.696) -0.24  (0.488)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 75 mg
Comments Change from Baseline at Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.135
Comments P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.87
Confidence Interval (2-Sided) 90%
-2.18 to 0.44
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.782
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 300 mg
Comments Change from Baseline at Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.818
Comments P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.59
Confidence Interval (2-Sided) 90%
-0.48 to 1.66
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.640
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 75 mg
Comments Change from Baseline at Week 7
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.591
Comments P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.18
Confidence Interval (2-Sided) 90%
-1.11 to 1.47
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.770
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 300 mg
Comments Change from Baseline at Week 7
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.713
Comments P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.36
Confidence Interval (2-Sided) 90%
-0.71 to 1.44
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.643
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 75 mg
Comments Change from Baseline at Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.616
Comments P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.24
Confidence Interval (2-Sided) 90%
-1.13 to 1.62
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.822
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 300 mg
Comments Change from Baseline at Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.708
Comments P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.37
Confidence Interval (2-Sided) 90%
-0.76 to 1.51
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.679
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in the Inverse Time to Complete the 9-HPT-1
Hide Description The 9-HPT-1 is a measure of timed upper extremity (arm and hand) function and manual dexterity. The participant picks up pegs 1 at a time (9 in total), using 1 hand only, and places them into holes on the board as quickly as possible, in any order until all holes are filled. Then, without pausing, the participant removes the pegs 1 at a time and returns them as quickly as possible. Each participant performs this task twice with each hand separately. Results on both tests are then averaged for an overall task completion time, and the inverse transform is performed. A positive change from Baseline indicates improvement. Change from Baseline in 9-HPT-1 was analyzed using MMRM ANCOVA with Baseline 9-HPT-1 as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline 9-HPT-1-by-visit interactions.
Time Frame Baseline and Weeks 2 and 7
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point.
Arm/Group Title Placebo TAK-831 75 mg TAK-831 300 mg
Hide Arm/Group Description:
TAK-831 placebo-matching tablets, orally, twice daily for up to 12 weeks.
TAK-831 75 mg, tablets, orally, twice daily for up to 12 weeks.
TAK-831 300 mg, tablets, orally, twice daily for up to 12 weeks.
Overall Number of Participants Analyzed 27 14 26
Least Squares Mean (Standard Error)
Unit of Measure: 1/seconds
Change from Baseline at Week 2 Number Analyzed 27 participants 14 participants 26 participants
0.00087  (0.000371) 0.00048  (0.000508) -0.00006  (0.000370)
Change from Baseline at Week 7 Number Analyzed 26 participants 13 participants 24 participants
0.00040  (0.000462) 0.00026  (0.000643) -0.00004  (0.000471)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 75 mg
Comments Change from Baseline at Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.741
Comments P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.00039
Confidence Interval (2-Sided) 90%
-0.00140 to 0.00062
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.000604
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 300 mg
Comments Change from Baseline at Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.964
Comments P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.00093
Confidence Interval (2-Sided) 90%
-0.00177 to -0.00008
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.000505
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 75 mg
Comments Change from Baseline at Week 7
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.573
Comments P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.00014
Confidence Interval (2-Sided) 90%
-0.00143 to 0.00115
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.000772
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 300 mg
Comments Change from Baseline at Week 7
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.749
Comments P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.00044
Confidence Interval (2-Sided) 90%
-0.00152 to 0.00064
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.000646
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in the ADL Component Individual Item Scores
Hide Description The ADL component of the FARS includes 9 subscales: speech, swallowing, cutting food and handling utensils, dressing, personal hygiene, falling, walking, quality of sitting position, and bladder function. Each of these subscales is rated on a 5-point scale where 0=normal to 4=severe disability/inability to carry out activity independently. A negative change from Baseline indicates improvement. Statistical analyses were available for the following subscales: cutting food-handling utensils, dressing and personal hygiene.
Time Frame Baseline and Weeks 2, 7 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point.
Arm/Group Title Placebo TAK-831 75 mg TAK-831 300 mg
Hide Arm/Group Description:
TAK-831 placebo-matching tablets, orally, twice daily for up to 12 weeks.
TAK-831 75 mg, tablets, orally, twice daily for up to 12 weeks.
TAK-831 300 mg, tablets, orally, twice daily for up to 12 weeks.
Overall Number of Participants Analyzed 27 14 26
Mean (Standard Deviation)
Unit of Measure: score on a scale
Change at Week 2, Speech Number Analyzed 27 participants 13 participants 26 participants
0.07  (0.494) -0.15  (0.427) -0.06  (0.432)
Change at Week 7, Speech Number Analyzed 26 participants 13 participants 24 participants
0.06  (0.516) -0.08  (0.400) -0.15  (0.429)
Change at Week 12, Speech Number Analyzed 24 participants 12 participants 24 participants
0.06  (0.425) -0.17  (0.492) -0.02  (0.403)
Change at Week 2, Swallowing Number Analyzed 27 participants 13 participants 26 participants
0.00  (0.555) 0.04  (0.320) -0.19  (0.618)
Change at Week 7, Swallowing Number Analyzed 26 participants 13 participants 24 participants
0.04  (0.422) 0.08  (0.534) -0.06  (0.756)
Change at Week 12, Swallowing Number Analyzed 24 participants 12 participants 24 participants
-0.15  (0.403) 0.13  (0.311) -0.27  (0.589)
Change at Week 2, Cutting-Handling Utensils Number Analyzed 27 participants 13 participants 26 participants
-0.13  (0.451) -0.04  (0.380) 0.12  (0.535)
Change at Week 7, Cutting-Handling Utensils Number Analyzed 26 participants 13 participants 24 participants
-0.21  (0.619) -0.15  (0.240) 0.08  (0.525)
Change at Week 12, Cutting-Handling Utensils Number Analyzed 24 participants 12 participants 24 participants
-0.19  (0.548) -0.08  (0.417) 0.08  (0.482)
Change at Week 2, Dressing Number Analyzed 27 participants 13 participants 26 participants
0.00  (0.392) -0.12  (0.506) 0.12  (0.516)
Change at Week 7, Dressing Number Analyzed 26 participants 13 participants 24 participants
0.04  (0.372) 0.04  (0.380) -0.04  (0.292)
Change at Week 12, Dressing Number Analyzed 24 participants 12 participants 24 participants
0.02  (0.561) -0.04  (0.498) -0.10  (0.361)
Change at Week 2, Personal Hygiene Number Analyzed 27 participants 13 participants 26 participants
-0.02  (0.427) 0.00  (0.456) 0.15  (0.485)
Change at Week 7, Personal Hygiene Number Analyzed 26 participants 13 participants 24 participants
0.08  (0.659) 0.19  (0.560) 0.04  (0.530)
Change at Week 12, Personal Hygiene Number Analyzed 24 participants 12 participants 24 participants
0.08  (0.602) 0.21  (0.656) 0.06  (0.517)
Change at Week 2, Falling Number Analyzed 27 participants 13 participants 26 participants
0.06  (0.560) 0.04  (0.660) 0.02  (0.435)
Change at Week 7, Falling Number Analyzed 26 participants 13 participants 24 participants
-0.13  (0.481) 0.54  (1.266) -0.04  (0.706)
Change at Week 12, Falling Number Analyzed 24 participants 12 participants 24 participants
-0.29  (0.932) 0.50  (0.739) -0.33  (0.856)
Change at Week 2, Walking Number Analyzed 27 participants 13 participants 26 participants
-0.02  (0.470) -0.08  (0.494) 0.08  (0.272)
Change at Week 7, Walking Number Analyzed 26 participants 13 participants 24 participants
0.00  (0.245) -0.08  (0.344) -0.06  (0.450)
Change at Week 12, Walking Number Analyzed 24 participants 12 participants 24 participants
0.13  (0.516) -0.08  (0.557) 0.02  (0.179)
Change at Week 2, Quality of Sitting Position Number Analyzed 27 participants 13 participants 26 participants
0.09  (0.605) -0.31  (0.663) 0.10  (0.375)
Change at Week 7, Quality of Sitting Position Number Analyzed 26 participants 13 participants 24 participants
0.06  (0.497) -0.27  (0.753) 0.00  (0.511)
Change at Week 12,Quality of Sitting Position Number Analyzed 24 participants 12 participants 24 participants
0.10  (0.589) -0.33  (0.778) 0.08  (0.458)
Change at Week 2, Bladder Function Number Analyzed 27 participants 13 participants 26 participants
-0.09  (0.555) -0.27  (0.439) 0.13  (0.460)
Change at Week 7, Bladder Function Number Analyzed 26 participants 13 participants 24 participants
-0.08  (0.643) -0.15  (0.555) 0.08  (0.381)
Change at Week 12, Bladder Function Number Analyzed 24 participants 12 participants 24 participants
-0.17  (0.504) -0.42  (0.557) -0.04  (0.550)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 75 mg
Comments Change at Week 2, Cutting-Handling Utensils
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.571
Comments P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.03
Confidence Interval (2-Sided) 90%
-0.23 to 0.29
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.154
Estimation Comments MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 300 mg
Comments Change at Week 2, Cutting-Handling Utensils
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.963
Comments P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.23
Confidence Interval (2-Sided) 90%
0.02 to 0.44
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.126
Estimation Comments MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 75 mg
Comments Change at Week 7, Cutting-Handling Utensils
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.515
Comments P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.01
Confidence Interval (2-Sided) 90%
-0.27 to 0.28
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.165
Estimation Comments MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 300 mg
Comments Change at Week 7, Cutting-Handling Utensils
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.986
Comments P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.31
Confidence Interval (2-Sided) 90%
0.08 to 0.54
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.138
Estimation Comments MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 75 mg
Comments Change at Week 12, Cutting-Handling Utensils
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.718
Comments P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.09
Confidence Interval (2-Sided) 90%
-0.18 to 0.37
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.162
Estimation Comments MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 300 mg
Comments Change at Week 12, Cutting-Handling Utensils
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.986
Comments P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.30
Confidence Interval (2-Sided) 90%
0.08 to 0.52
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.133
Estimation Comments MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 75 mg
Comments Change at Week 2, Dressing
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.153
Comments P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.15
Confidence Interval (2-Sided) 90%
-0.40 to 0.09
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.148
Estimation Comments MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 300 mg
Comments Change at Week 2, Dressing
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.861
Comments P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.13
Confidence Interval (2-Sided) 90%
-0.07 to 0.33
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.119
Estimation Comments MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 75 mg
Comments Change at Week 7, Dressing
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.443
Comments P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.02
Confidence Interval (2-Sided) 90%
-0.22 to 0.18
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.120
Estimation Comments MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 300 mg
Comments Change at Week 7, Dressing
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.359
Comments P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.04
Confidence Interval (2-Sided) 90%
-0.20 to 0.13
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.100
Estimation Comments MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 75 mg
Comments Change at Week 12, Dressing
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.268
Comments P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.10
Confidence Interval (2-Sided) 90%
-0.36 to 0.17
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.157
Estimation Comments MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 300 mg
Comments Change at Week 12, Dressing
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.411
Comments P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.03
Confidence Interval (2-Sided) 90%
-0.24 to 0.19
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.129
Estimation Comments MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 75 mg
Comments Change at Week 2, Personal Hygiene
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.358
Comments P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.06
Confidence Interval (2-Sided) 90%
-0.31 to 0.20
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.151
Estimation Comments MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 300 mg
Comments Change at Week 2, Personal Hygiene
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.946
Comments P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.20
Confidence Interval (2-Sided) 90%
0.00 to 0.41
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.123
Estimation Comments MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 75 mg
Comments Change at Week 7, Personal Hygiene
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.505
Comments P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.00
Confidence Interval (2-Sided) 90%
-0.32 to 0.33
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.193
Estimation Comments MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 300 mg
Comments Change at Week 7, Personal Hygiene
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.658
Comments P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.06
Confidence Interval (2-Sided) 90%
-0.20 to 0.33
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.158
Estimation Comments MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.
Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 75 mg
Comments Change at Week 12, Personal Hygiene
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.649
Comments P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.07
Confidence Interval (2-Sided) 90%
-0.24 to 0.38
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.184
Estimation Comments MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.
Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 300 mg
Comments Change at Week 12, Personal Hygiene
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.661
Comments P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.06
Confidence Interval (2-Sided) 90%
-0.19 to 0.32
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.151
Estimation Comments MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.
5.Secondary Outcome
Title Change From Baseline in the Modified Friedreich Ataxia Rating Scale Neurological Examination (mFARS-neuro) Total Score
Hide Description The mFARS-neuro neurological examination is a clinician-rated measure based on neural substrates affected in Friedreich ataxia including: bulbar on a scale of 0-11, upper limb coordination on a scale of 0-36, lower limb coordination on a scale of 0-16, and upright stability/gait functions on a scale of 0-36 for a total possible score of 0 to 99 with higher scores representing greater disability. A negative change from Baseline indicates improvement. Change from Baseline in mFARS-neuro was analyzed using MMRM ANCOVA with Baseline mFARS-neuro as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline mFARS-neuro-by-visit interactions.
Time Frame Baseline and Weeks 2, 7 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point.
Arm/Group Title Placebo TAK-831 75 mg TAK-831 300 mg
Hide Arm/Group Description:
TAK-831 placebo-matching tablets, orally, twice daily for up to 12 weeks.
TAK-831 75 mg, tablets, orally, twice daily for up to 12 weeks.
TAK-831 300 mg, tablets, orally, twice daily for up to 12 weeks.
Overall Number of Participants Analyzed 27 14 26
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
Change from Baseline at Week 2 Number Analyzed 27 participants 13 participants 26 participants
-3.36  (0.650) -0.70  (0.919) -0.58  (0.647)
Change from Baseline at Week 7 Number Analyzed 26 participants 13 participants 23 participants
-2.41  (0.799) -2.01  (1.114) -1.35  (0.828)
Change from Baseline at Week 12 Number Analyzed 24 participants 12 participants 24 participants
-3.30  (0.762) -1.28  (1.057) -1.19  (0.752)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 75 mg
Comments Change from Baseline at Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.992
Comments P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 2.67
Confidence Interval (2-Sided) 90%
0.86 to 4.47
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.078
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 300 mg
Comments Change from Baseline at Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.999
Comments P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 2.78
Confidence Interval (2-Sided) 90%
1.29 to 4.28
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.892
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 75 mg
Comments Change from Baseline at Week 7
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.616
Comments P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.40
Confidence Interval (2-Sided) 90%
-1.84 to 2.64
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.338
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 300 mg
Comments Change from Baseline at Week 7
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.823
Comments P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 1.06
Confidence Interval (2-Sided) 90%
-0.83 to 2.95
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.131
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 75 mg
Comments Change from Baseline at Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.942
Comments P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 2.02
Confidence Interval (2-Sided) 90%
-0.10 to 4.13
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.266
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 300 mg
Comments Change from Baseline at Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.975
Comments P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 2.11
Confidence Interval (2-Sided) 90%
0.35 to 3.87
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.053
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in the mFARS-neuro Subscales Scores
Hide Description The mFARS-neuro neurological examination is a clinician-rated measure based on neural substrates affected in Friedreich ataxia including: bulbar on a scale of 0-11, upper limb coordination on a scale of 0-36, lower limb coordination on a scale of 0-16, and upright stability/gait functions on a scale of 0-36, with the higher scores representing greater disability. A negative change from Baseline indicates improvement. Change from Baseline in mFARS-neuro was analyzed using MMRM ANCOVA with Baseline mFARS-neuro as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline mFARS-neuro-by visit interactions.
Time Frame Baseline and Weeks 2, 7, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point.
Arm/Group Title Placebo TAK-831 75 mg TAK-831 300 mg
Hide Arm/Group Description:
TAK-831 placebo-matching tablets, orally, twice daily for up to 12 weeks.
TAK-831 75 mg, tablets, orally, twice daily for up to 12 weeks.
TAK-831 300 mg, tablets, orally, twice daily for up to 12 weeks.
Overall Number of Participants Analyzed 27 14 26
Least Squares Mean (Standard Error)
Unit of Measure: unit on a scale
Change at Week 2, Bulbar Number Analyzed 27 participants 13 participants 26 participants
0.08  (0.080) 0.15  (0.112) 0.14  (0.082)
Change at Week 7, Bulbar Number Analyzed 26 participants 13 participants 23 participants
0.01  (0.074) -0.08  (0.102) 0.17  (0.079)
Change at Week 12, Bulbar Number Analyzed 24 participants 12 participants 24 participants
0.01  (0.085) 0.06  (0.118) 0.21  (0.087)
Change at Week 2, Upper Limb Coordination Number Analyzed 27 participants 13 participants 26 participants
-1.55  (0.425) 0.44  (0.601) -0.53  (0.419)
Change at Week 7, Upper Limb Coordination Number Analyzed 26 participants 13 participants 23 participants
-0.90  (0.533) 0.17  (0.741) -0.72  (0.547)
Change at Week 12, Upper Limb Coordination Number Analyzed 24 participants 12 participants 24 participants
-1.19  (0.608) 0.02  (0.848) -0.65  (0.602)
Change at Week 2, Lower Limb Coordination Number Analyzed 27 participants 13 participants 26 participants
-0.92  (0.292) -0.52  (0.415) -0.14  (0.289)
Change at Week 7, Lower Limb Coordination Number Analyzed 26 participants 13 participants 23 participants
-0.84  (0.494) -0.88  (0.691) -0.67  (0.516)
Change at Week 12, Lower Limb Coordination Number Analyzed 24 participants 12 participants 24 participants
-1.62  (0.449) -0.63  (0.625) -0.67  (0.445)
Change at Week 2, Upright Stability Number Analyzed 27 participants 13 participants 26 participants
-0.5  (0.37) -0.3  (0.53) 0.5  (0.38)
Change at Week 7, Upright Stability Number Analyzed 26 participants 13 participants 23 participants
-0.2  (0.27) -0.8  (0.38) 0.4  (0.28)
Change at Week 12, Upright Stability Number Analyzed 24 participants 12 participants 24 participants
-0.1  (0.35) -0.3  (0.48) 0.4  (0.34)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 75 mg
Comments Change at Week 2, Bulbar
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.07
Confidence Interval (2-Sided) 90%
-0.15 to 0.29
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.133
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 300 mg
Comments Change at Week 2, Bulbar
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.06
Confidence Interval (2-Sided) 90%
-0.12 to 0.25
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.110
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 75 mg
Comments Change at Week 7, Bulbar
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.10
Confidence Interval (2-Sided) 90%
-0.30 to 0.11
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.122
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 300 mg
Comments Change at Week 7, Bulbar
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.16
Confidence Interval (2-Sided) 90%
-0.02 to 0.33
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.104
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 75 mg
Comments Change at Week 12, Bulbar
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.05
Confidence Interval (2-Sided) 90%
-0.19 to 0.28
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.141
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 300 mg
Comments Change at Week 12, Bulbar
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.20
Confidence Interval (2-Sided) 90%
0.00 to 0.40
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.118
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 75 mg
Comments Change at Week 2, Upper Limb Coordination
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 1.99
Confidence Interval (2-Sided) 90%
0.83 to 3.14
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.689
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 300 mg
Comments Change at Week 2, Upper Limb Coordination
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 1.02
Confidence Interval (2-Sided) 90%
0.06 to 1.97
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.571
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 75 mg
Comments Change at Week 7, Upper Limb Coordination
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 1.08
Confidence Interval (2-Sided) 90%
-0.40 to 2.55
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.882
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 300 mg
Comments Change at Week 7, Upper Limb Coordination
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.18
Confidence Interval (2-Sided) 90%
-1.06 to 1.43
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.743
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 75 mg
Comments Change at Week 12, Upper Limb Coordination
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 1.21
Confidence Interval (2-Sided) 90%
-0.48 to 2.91
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.016
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 300 mg
Comments Change at Week 12, Upper Limb Coordination
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.53
Confidence Interval (2-Sided) 90%
-0.87 to 1.94
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.840
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 75 mg
Comments Change at Week 2, Lower Limb Coordination
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.40
Confidence Interval (2-Sided) 90%
-0.41 to 1.20
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.482
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 300 mg
Comments Change at Week 2, Lower Limb Coordination
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.79
Confidence Interval (2-Sided) 90%
0.12 to 1.45
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.397
Estimation Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 75 mg
Comments Change at Week 7, Lower Limb Coordination
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.04
Confidence Interval (2-Sided) 90%
-1.44 to 1.36
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.837
Estimation Comments [Not Specified]
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 300 mg
Comments Change at Week 7, Lower Limb Coordination
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.17
Confidence Interval (2-Sided) 90%
-1.01 to 1.36
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.707
Estimation Comments [Not Specified]
Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 75 mg
Comments Change at Week 12, Lower Limb Coordination
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.99
Confidence Interval (2-Sided) 90%
-0.27 to 2.25
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.755
Estimation Comments [Not Specified]
Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 300 mg
Comments Change at Week 12, Lower Limb Coordination
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.95
Confidence Interval (2-Sided) 90%
-0.09 to 2.00
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.626
Estimation Comments [Not Specified]
Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 75 mg
Comments Change at Week 2, Upright Stability
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.2
Confidence Interval (2-Sided) 90%
-0.8 to 1.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.63
Estimation Comments [Not Specified]
Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 300 mg
Comments Change at Week 2, Upright Stability
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 1.0
Confidence Interval (2-Sided) 90%
0.1 to 1.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.52
Estimation Comments [Not Specified]
Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 75 mg
Comments Change at Week 7, Upright Stability
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.5
Confidence Interval (2-Sided) 90%
-1.3 to 0.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.45
Estimation Comments [Not Specified]
Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 300 mg
Comments Change at Week 7, Upright Stability
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.6
Confidence Interval (2-Sided) 90%
0.0 to 1.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.38
Estimation Comments [Not Specified]
Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 75 mg
Comments Change at Week 12, Upright Stability
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.2
Confidence Interval (2-Sided) 90%
-1.2 to 0.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.57
Estimation Comments [Not Specified]
Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 300 mg
Comments Change at Week 12, Upright Stability
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.5
Confidence Interval (2-Sided) 90%
-0.3 to 1.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.48
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in the mFARS-neuro Individual Item Scores
Hide Description mFARS-neuro examination is a clinician-rated measure based on neural substrates affected in Friedreich ataxia individual items:Cough,Speech,Right(R)Finger to Finger Test,Left(L)Finger to Finger Test,R-Nose to Finger Test,L-Nose to Finger Test,R-Dysmetria Test,L-Dysmetria Test,Rapid Alternating Movement(RAM)of R-Hands,RAM of L-Hands,R-Finger Taps(FT),L-FT,R-Heel Along Shin Slide,L-Heel Along Shin Slide,R-Heel Along Shin Tap,L-Heel Along Shin Tap,Siting Posture,Stance Feet Apart(SFA)-3 Trial Average(TTA),SFA(Eyes Closed)-TTA,Stance Feet Together(SFT)-TTA,SFT(Eyes Closed)-TTA,Tandem Stance-TTA,Stance on Dominant Foot-TTA,Tandem Walk and Gait.Items were scored on scale of 0 to 2,3,4 or 5,with higher scores indicating greater disability.Negative change from Baseline(BL)indicates improvement.Change from BL in mFARS-neuro was analyzed using MMRM ANCOVA with BL as covariate;pooled site,visit,treatment,ambulation status as fixed factors;treatment-by-visit,BL mFARS-neuro-by visit interactions.
Time Frame Baseline and Weeks 2, 7, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point.
Arm/Group Title Placebo TAK-831 75 mg TAK-831 300 mg
Hide Arm/Group Description:
TAK-831 placebo-matching tablets, orally, twice daily for up to 12 weeks.
TAK-831 75 mg, tablets, orally, twice daily for up to 12 weeks.
TAK-831 300 mg, tablets, orally, twice daily for up to 12 weeks.
Overall Number of Participants Analyzed 27 14 26
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
Change at Week 2, Cough (0-2) Number Analyzed 27 participants 13 participants 26 participants
0.06  (0.051) 0.07  (0.072) 0.06  (0.051)
Change at Week 7, Cough (0-2) Number Analyzed 26 participants 13 participants 23 participants
0.01  (0.063) -0.05  (0.087) 0.11  (0.065)
Change at Week 12, Cough (0-2) Number Analyzed 24 participants 12 participants 24 participants
0.01  (0.063) 0.08  (0.088) 0.13  (0.063)
Change at Week 2, Speech (0-3) Number Analyzed 27 participants 13 participants 26 participants
0.00  (0.058) 0.08  (0.083) 0.10  (0.060)
Change at Week 7, Speech (0-3) Number Analyzed 26 participants 13 participants 23 participants
0.00  (0.043) -0.04  (0.060) 0.07  (0.045)
Change at Week 12, Speech (0-3) Number Analyzed 24 participants 12 participants 24 participants
0.00  (0.056) 0.00  (0.079) 0.09  (0.057)
Change at Week 2,Right Finger to Finger Test(0-3) Number Analyzed 27 participants 13 participants 26 participants
0.10  (0.079) 0.17  (0.109) 0.06  (0.078)
Change at Week 7,Right Finger to Finger Test(0-3) Number Analyzed 26 participants 13 participants 23 participants
0.04  (0.075) 0.12  (0.102) -0.02  (0.075)
Change at Week 12,Right Finger to Finger Test(0-3) Number Analyzed 24 participants 12 participants 24 participants
0.21  (0.077) 0.12  (0.105) 0.06  (0.074)
Change at Week 2, Left Finger to Finger Test (0-3) Number Analyzed 27 participants 13 participants 26 participants
0.04  (0.085) 0.13  (0.120) 0.07  (0.084)
Change at Week 7, Left Finger to Finger Test (0-3) Number Analyzed 26 participants 13 participants 23 participants
0.05  (0.075) 0.07  (0.104) 0.07  (0.077)
Change at Week 12,Left Finger to Finger Test(0-3) Number Analyzed 24 participants 12 participants 24 participants
0.13  (0.095) 0.22  (0.132) 0.04  (0.093)
Change at Week 2, Right Nose to Finger Test (0-4) Number Analyzed 27 participants 13 participants 26 participants
-0.08  (0.085) 0.21  (0.126) 0.06  (0.085)
Change at Week 7, Right Nose to Finger Test (0-4) Number Analyzed 26 participants 13 participants 23 participants
0.01  (0.103) 0.09  (0.147) -0.07  (0.107)
Change at Week 12, Right Nose to Finger Test (0-4) Number Analyzed 24 participants 12 participants 24 participants
0.00  (0.098) -0.15  (0.140) 0.00  (0.097)
Change at Week 2, Left Nose to Finger Test (0-4) Number Analyzed 27 participants 13 participants 26 participants
-0.05  (0.096) 0.08  (0.137) 0.05  (0.095)
Change at Week 7, Left Nose to Finger Test (0-4) Number Analyzed 26 participants 13 participants 23 participants
0.15  (0.095) 0.32  (0.133) 0.01  (0.098)
Change at Week 12, Left Nose to Finger Test (0-4) Number Analyzed 24 participants 12 participants 24 participants
0.11  (0.103) 0.10  (0.141) 0.14  (0.099)
Change at Week 2, Right Dysmetria Test (0-4) Number Analyzed 27 participants 13 participants 26 participants
-0.11  (0.106) -0.15  (0.151) 0.01  (0.105)
Change at Week 7, Right Dysmetria Test (0-4) Number Analyzed 26 participants 13 participants 23 participants
-0.23  (0.129) -0.11  (0.181) -0.06  (0.134)
Change at Week 12, Right Dysmetria Test (0-4) Number Analyzed 24 participants 12 participants 24 participants
-0.11  (0.132) 0.01  (0.185) -0.16  (0.130)
Change at Week 2, Left Dysmetria Test (0-4) Number Analyzed 27 participants 13 participants 26 participants
-0.27  (0.111) 0.02  (0.160) -0.12  (0.110)
Change at Week 7, Left Dysmetria Test (0-4) Number Analyzed 27 participants 13 participants 23 participants
-0.02  (0.136) -0.26  (0.191) -0.16  (0.141)
Change at Week 12, Left Dysmetria Test (0-4) Number Analyzed 24 participants 12 participants 24 participants
-0.17  (0.151) -0.11  (0.211) 0.06  (0.149)
Change at Week 2, RAM of Right Hands (0-3) Number Analyzed 27 participants 13 participants 26 participants
-0.18  (0.103) 0.05  (0.145) -0.06  (0.102)
Change at Week 7, RAM of Right Hands (0-3) Number Analyzed 26 participants 13 participants 23 participants
0.03  (0.122) -0.03  (0.170) 0.03  (0.126)
Change at Week 12, RAM of Right Hands (0-3) Number Analyzed 24 participants 12 participants 24 participants
-0.07  (0.113) 0.12  (0.156) -0.12  (0.112)
Change at Week 2, RAM of Left Hands (0-3) Number Analyzed 27 participants 13 participants 26 participants
-0.11  (0.085) -0.03  (0.120) -0.03  (0.085)
Change at Week 7, RAM of Left Hands (0-3) Number Analyzed 26 participants 13 participants 23 participants
-0.08  (0.123) 0.01  (0.173) 0.05  (0.129)
Change at Week 12, RAM of Left Hands (0-3) Number Analyzed 24 participants 12 participants 24 participants
-0.20  (0.096) 0.11  (0.133) 0.02  (0.095)
Change at Week 2, Right Finger Taps (0-4) Number Analyzed 27 participants 13 participants 26 participants
-0.39  (0.121) 0.05  (0.172) -0.23  (0.124)
Change at Week 7, Right Finger Taps (0-4) Number Analyzed 26 participants 13 participants 23 participants
-0.18  (0.136) 0.04  (0.190) -0.19  (0.143)
Change at Week 12, Right Finger Taps (0-4) Number Analyzed 24 participants 12 participants 24 participants
-0.31  (0.140) -0.13  (0.195) -0.37  (0.140)
Change at Week 2, Left Finger Taps (0-4) Number Analyzed 27 participants 13 participants 26 participants
-0.22  (0.132) 0.28  (0.189) -0.17  (0.132)
Change at Week 7, Left Finger Taps (0-4) Number Analyzed 26 participants 13 participants 23 participants
-0.37  (0.131) 0.22  (0.182) -0.21  (0.136)
Change at Week 12, Left Finger Taps (0-4) Number Analyzed 24 participants 12 participants 24 participants
-0.50  (0.161) 0.07  (0.225) -0.17  (0.160)
Change at Week 2,Right Heel Along Shin Slide(0-4) Number Analyzed 27 participants 13 participants 26 participants
-0.24  (0.118) -0.04  (0.166) -0.24  (0.117)
Change at Week 7,Right Heel Along Shin Slide(0-4) Number Analyzed 25 participants 13 participants 23 participants
-0.18  (0.152) -0.32  (0.209) -0.35  (0.155)
Change at Week 12,Right Heel Along Shin Slide(0-4) Number Analyzed 23 participants 12 participants 24 participants
-0.43  (0.164) -0.09  (0.223) -0.30  (0.160)
Change at Week 2, Left Heel Along Shin Slide (0-4) Number Analyzed 27 participants 13 participants 26 participants
0.01  (0.121) -0.15  (0.174) 0.05  (0.121)
Change at Week 7, Left Heel Along Shin Slide (0-4) Number Analyzed 26 participants 13 participants 23 participants
0.08  (0.133) -0.23  (0.187) -0.09  (0.138)
Change at Week 12,Left Heel Along Shin Slide(0-4) Number Analyzed 24 participants 12 participants 24 participants
-0.16  (0.151) -0.18  (0.210) -0.15  (0.149)
Change at Week 2, Right Heel Along Shin Tap (0-4) Number Analyzed 27 participants 13 participants 26 participants
-0.39  (0.114) -0.17  (0.159) 0.04  (0.113)
Change at Week 7, Right Heel Along Shin Tap (0-4) Number Analyzed 25 participants 13 participants 23 participants
-0.14  (0.163) -0.41  (0.224) -0.14  (0.168)
Change at Week 12, Right Heel Along Shin Tap (0-4) Number Analyzed 23 participants 12 participants 24 participants
-0.32  (0.137) -0.18  (0.184) 0.01  (0.131)
Change at Week 2, Left Heel Along Shin Tap (0-4) Number Analyzed 27 participants 13 participants 26 participants
-0.38  (0.121) -0.22  (0.171) -0.05  (0.120)
Change at Week 7, Left Heel Along Shin Tap (0-4) Number Analyzed 26 participants 13 participants 23 participants
-0.36  (0.165) 0.01  (0.230) -0.15  (0.171)
Change at Week 12, Left Heel Along Shin Tap (0-4) Number Analyzed 24 participants 12 participants 24 participants
-0.52  (0.180) -0.21  (0.251) -0.27  (0.178)
Change at Week 2, Siting Posture (0-4) Number Analyzed 27 participants 13 participants 26 participants
-0.3  (0.11) -0.1  (0.15) -0.1  (0.11)
Change at Week 7, Siting Posture (0-4) Number Analyzed 26 participants 13 participants 23 participants
-0.4  (0.11) -0.5  (0.15) -0.2  (0.11)
Change at Week 12, Siting Posture (0-4) Number Analyzed 24 participants 12 participants 24 participants
-0.1  (0.12) -0.3  (0.16) -0.1  (0.11)
Change at Week 2, SFA -TTA (0-4) Number Analyzed 27 participants 13 participants 26 participants
-0.1  (0.15) 0.0  (0.21) -0.1  (0.15)
Change at Week 7, SFA - TTA (0-4) Number Analyzed 26 participants 13 participants 23 participants
0.1  (0.12) 0.0  (0.17) -0.1  (0.12)
Change at Week 12, SFA - TTA (0-4) Number Analyzed 24 participants 12 participants 24 participants
-0.1  (0.13) 0.0  (0.19) 0.0  (0.13)
Change at Week 2, SFA (Eyes Closed) - TTA (0-4) Number Analyzed 27 participants 13 participants 26 participants
0.0  (0.07) 0.1  (0.10) -0.1  (0.07)
Change at Week 7, SFA (Eyes Closed) - TTA (0-4) Number Analyzed 26 participants 13 participants 23 participants
0.2  (0.11) 0.1  (0.16) 0.0  (0.12)
Change at Week 12, SFA (Eyes Closed) - TTA (0-4) Number Analyzed 24 participants 12 participants 24 participants
0.2  (0.14) 0.2  (0.19) 0.0  (0.14)
Change at Week 2, SFT - TTA (0-4) Number Analyzed 27 participants 13 participants 26 participants
0.0  (0.18) -0.3  (0.26) 0.4  (0.19)
Change at Week 7, SFT - TTA (0-4) Number Analyzed 26 participants 13 participants 23 participants
-0.1  (0.11) -0.1  (0.15) 0.3  (0.11)
Change at Week 12, SFT - TTA (0-4) Number Analyzed 24 participants 12 participants 24 participants
0.0  (0.14) -0.2  (0.19) 0.3  (0.14)
Change at Week 2, SFT (Eyes Closed) - TTA (0-4) Number Analyzed 27 participants 13 participants 26 participants
0.1  (0.06) 0.1  (0.09) 0.0  (0.06)
Change at Week 7, SFT (Eyes Closed) - TTA (0-4) Number Analyzed 26 participants 13 participants 23 participants
0.1  (0.06) 0.1  (0.09) 0.1  (0.07)
Change at Week 12, SFT (Eyes Closed) - TTA (0-4) Number Analyzed 24 participants 12 participants 24 participants
0.0  (0.07) 0.0  (0.09) -0.1  (0.06)
Change at Week 2, Tandem Stance - TTA (0-4) Number Analyzed 27 participants 13 participants 26 participants
0.0  (0.05) 0.0  (0.07) 0.0  (0.05)
Change at Week 7, Tandem Stance - TTA (0-4) Number Analyzed 26 participants 13 participants 23 participants
0.0  (0.05) -0.1  (0.07) 0.1  (0.05)
Change at Week 12, Tandem Stance - TTA (0-4) Number Analyzed 24 participants 12 participants 24 participants
0.1  (0.05) 0.0  (0.07) 0.1  (0.05)
Change at Week 2,Stance on Dominant Foot-TTA(0-4) Number Analyzed 27 participants 13 participants 26 participants
NA [1]   (NA) NA [2]   (NA) NA [2]   (NA)
Change at Week 7,Stance on Dominant Foot-TTA(0-4) Number Analyzed 26 participants 13 participants 23 participants
NA [2]   (NA) NA [2]   (NA) NA [2]   (NA)
Change at Week 12,Stance on Dominant Foot-TTA(0-4) Number Analyzed 24 participants 12 participants 24 participants
NA [2]   (NA) NA [2]   (NA) NA [2]   (NA)
Change at Week 2, Tandem Walk (0-3) Number Analyzed 27 participants 13 participants 26 participants
0.0  (0.05) 0.0  (0.07) 0.0  (0.05)
Change at Week 7, Tandem Walk (0-3) Number Analyzed 26 participants 13 participants 23 participants
0.0  (0.05) -0.1  (0.07) 0.0  (0.05)
Change at Week 12, Tandem Walk (0-3) Number Analyzed 24 participants 12 participants 24 participants
0.0  (0.06) -0.1  (0.08) 0.0  (0.06)
Change at Week 2, Gait (0-5) Number Analyzed 27 participants 13 participants 26 participants
-0.3  (0.12) -0.2  (0.17) 0.2  (0.12)
Change at Week 7, Gait (0-5) Number Analyzed 26 participants 13 participants 23 participants
-0.1  (0.11) -0.3  (0.15) 0.2  (0.11)
Change at Week 12, Gait (0-5) Number Analyzed 24 participants 12 participants 24 participants
-0.1  (0.11) -0.2  (0.15) 0.1  (0.10)
[1]
The least squares (LS) mean and standard error (SE) was not estimable as there was no change from baseline in subscale score at this time point.
[2]
The LS mean and SE was not estimable as there was no change from baseline in subscale score at this time point.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 75 mg
Comments Change at Week 2, Cough
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.01
Confidence Interval (2-Sided) 90%
-0.13 to 0.15
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.084
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 300 mg
Comments Change at Week 2, Cough
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.00
Confidence Interval (2-Sided) 90%
-0.11 to 0.12
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.069
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 75 mg
Comments Change at Week 7, Cough
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.06
Confidence Interval (2-Sided) 90%
-0.24 to 0.11
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.105
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 300 mg
Comments Change at Week 7, Cough
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.10
Confidence Interval (2-Sided) 90%
-0.05 to 0.25
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.088
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 75 mg
Comments Change at Week 12, Cough
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.07
Confidence Interval (2-Sided) 90%
-0.11 to 0.25
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.106
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 300 mg
Comments Change at Week 12, Cough
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.12
Confidence Interval (2-Sided) 90%
-0.03 to 0.26
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.087
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 75 mg
Comments Change at Week 2, Speech
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.08
Confidence Interval (2-Sided) 90%
-0.09 to 0.25
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.100
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 300 mg
Comments Change at Week 2, Speech
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.10
Confidence Interval (2-Sided) 90%
-0.04 to 0.24
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.083
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 75 mg
Comments Change at Week 7, Speech
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.04
Confidence Interval (2-Sided) 90%
-0.16 to 0.08
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.071
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 300 mg
Comments Change at Week 7, Speech
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.07
Confidence Interval (2-Sided) 90%
-0.03 to 0.17
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.060
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 75 mg
Comments Change at Week 12, Speech
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.00
Confidence Interval (2-Sided) 90%
-0.16 to 0.16
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.095
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 300 mg
Comments Change at Week 12, Speech
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.09
Confidence Interval (2-Sided) 90%
-0.04 to 0.22
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.079
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 75 mg
Comments Change at Week 2, Right Finger to Finger Test
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.07
Confidence Interval (2-Sided) 90%
-0.14 to 0.29
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.131
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 300 mg
Comments Change at Week 2, Right Finger to Finger Test
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.04
Confidence Interval (2-Sided) 90%
-0.22 to 0.14
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.108
Estimation Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 75 mg
Comments Change at Week 7, Right Finger to Finger Test
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.07
Confidence Interval (2-Sided) 90%
-0.13 to 0.28
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.122
Estimation Comments [Not Specified]
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 300 mg
Comments Change at Week 7, Right Finger to Finger Test
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.07
Confidence Interval (2-Sided) 90%
-0.24 to 0.11
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.103
Estimation Comments [Not Specified]
Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 75 mg
Comments Change at Week 12, Right Finger to Finger Test
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.09
Confidence Interval (2-Sided) 90%
-0.30 to 0.12
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.126
Estimation Comments [Not Specified]
Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 300 mg
Comments Change at Week 12, Right Finger to Finger Test
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.14
Confidence Interval (2-Sided) 90%
-0.32 to 0.03
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.104
Estimation Comments [Not Specified]
Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 75 mg
Comments Change at Week 2, Left Finger to Finger Test
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.09
Confidence Interval (2-Sided) 90%
-0.15 to 0.33
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.142
Estimation Comments [Not Specified]
Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 300 mg
Comments Change at Week 2, Left Finger to Finger Test
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.04
Confidence Interval (2-Sided) 90%
-0.16 to 0.23
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.117
Estimation Comments [Not Specified]
Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 75 mg
Comments Change at Week 7, Left Finger to Finger Test
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.03
Confidence Interval (2-Sided) 90%
-0.18 to 0.23
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.123
Estimation Comments [Not Specified]
Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 300 mg
Comments Change at Week 7, Left Finger to Finger Test
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.03
Confidence Interval (2-Sided) 90%
-0.15 to 0.20
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.104
Estimation Comments [Not Specified]
Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 75 mg
Comments Change at Week 12, Left Finger to Finger Test
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.09
Confidence Interval (2-Sided) 90%
-0.17 to 0.36
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.158
Estimation Comments [Not Specified]
Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 300 mg
Comments Change at Week 12, Left Finger to Finger Test
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.09
Confidence Interval (2-Sided) 90%
-0.30 to 0.13
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.130
Estimation Comments [Not Specified]
Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 75 mg
Comments Change at Week 2, Right Nose to Finger Test
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.29
Confidence Interval (2-Sided) 90%
0.04 to 0.53
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.145
Estimation Comments [Not Specified]
Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 300 mg
Comments Change at Week 2, Right Nose to Finger Test
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.14
Confidence Interval (2-Sided) 90%
-0.06 to 0.33
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.118
Estimation Comments [Not Specified]
Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 75 mg
Comments Change at Week 7, Right Nose to Finger Test
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.07
Confidence Interval (2-Sided) 90%
-0.22 to 0.37
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.174
Estimation Comments [Not Specified]
Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 300 mg
Comments Change at Week 7, Right Nose to Finger Test
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.08
Confidence Interval (2-Sided) 90%
-0.32 to 0.16
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.146
Estimation Comments [Not Specified]
Hide Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 75 mg
Comments Change at Week 12, Right Nose to Finger Test
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.15
Confidence Interval (2-Sided) 90%
-0.43 to 0.12
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.166
Estimation Comments [Not Specified]
Hide Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 300 mg
Comments Change at Week 12, Right Nose to Finger Test
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.00
Confidence Interval (2-Sided) 90%
-0.23 to 0.23
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.136
Estimation Comments [Not Specified]
Hide Statistical Analysis 31
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 75 mg
Comments Change at Week 2, Left Nose to Finger Test
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.13
Confidence Interval (2-Sided) 90%
-0.14 to 0.40
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.161
Estimation Comments [Not Specified]
Hide Statistical Analysis 32
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 300 mg
Comments Change at Week 2, Left Nose to Finger Test
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.10
Confidence Interval (2-Sided) 90%
-0.12 to 0.33
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.133
Estimation Comments [Not Specified]
Hide Statistical Analysis 33
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 75 mg
Comments Change at Week 7, Left Nose to Finger Test
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.17
Confidence Interval (2-Sided) 90%
-0.09 to 0.43
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.157
Estimation Comments [Not Specified]
Hide Statistical Analysis 34
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 300 mg
Comments Change at Week 7, Left Nose to Finger Test
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.13
Confidence Interval (2-Sided) 90%
-0.36 to 0.09
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.134
Estimation Comments [Not Specified]
Hide Statistical Analysis 35
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 75 mg
Comments Change at Week 12, Left Nose to Finger Test
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.01
Confidence Interval (2-Sided) 90%
-0.29 to 0.27
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.169
Estimation Comments [Not Specified]
Hide Statistical Analysis 36
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 300 mg
Comments Change at Week 12, Left Nose to Finger Test
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.03
Confidence Interval (2-Sided) 90%
-0.21 to 0.27
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.141
Estimation Comments [Not Specified]
Hide Statistical Analysis 37
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 75 mg
Comments Change at Week 2, Right Dysmetria Test
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.04
Confidence Interval (2-Sided) 90%
-0.33 to 0.26
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.176
Estimation Comments [Not Specified]
Hide Statistical Analysis 38
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 300 mg
Comments Change at Week 2, Right Dysmetria Test
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.12
Confidence Interval (2-Sided) 90%
-0.12 to 0.36
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.145
Estimation Comments [Not Specified]
Hide Statistical Analysis 39
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 75 mg
Comments Change at Week 7, Right Dysmetria Test
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.12
Confidence Interval (2-Sided) 90%
-0.25 to 0.48
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.217
Estimation Comments [Not Specified]
Hide Statistical Analysis 40
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 300 mg
Comments Change at Week 7, Right Dysmetria Test
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.17
Confidence Interval (2-Sided) 90%
-0.14 to 0.47
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.183
Estimation Comments [Not Specified]
Hide Statistical Analysis 41
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 75 mg
Comments Change at Week 12, Right Dysmetria Test
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.11
Confidence Interval (2-Sided) 90%
-0.26 to 0.48
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.221
Estimation Comments [Not Specified]
Hide Statistical Analysis 42
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 300 mg
Comments Change at Week 12, Right Dysmetria Test
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.06
Confidence Interval (2-Sided) 90%
-0.36 to 0.25
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.183
Estimation Comments [Not Specified]
Hide Statistical Analysis 43
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 75 mg
Comments Change at Week 2, Left Dysmetria Test
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.29
Confidence Interval (2-Sided) 90%
-0.02 to 0.60
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.185
Estimation Comments [Not Specified]
Hide Statistical Analysis 44
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 300 mg
Comments Change at Week 2, Left Dysmetria Test
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.15
Confidence Interval (2-Sided) 90%
-0.10 to 0.41
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.153
Estimation Comments [Not Specified]
Hide Statistical Analysis 45
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 75 mg
Comments Change at Week 7, Left Dysmetria Test
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.25
Confidence Interval (2-Sided) 90%
-0.63 to 0.13
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.228
Estimation Comments [Not Specified]
Hide Statistical Analysis 46
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 300 mg
Comments Change at Week 7, Left Dysmetria Test
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.14
Confidence Interval (2-Sided) 90%
-0.47 to 0.18
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.192
Estimation Comments [Not Specified]
Hide Statistical Analysis 47
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 75 mg
Comments Change at Week 12, Left Dysmetria Test
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.06
Confidence Interval (2-Sided) 90%
-0.37 to 0.48
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.254
Estimation Comments [Not Specified]
Hide Statistical Analysis 48
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 300 mg
Comments Change at Week 12, Left Dysmetria Test
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.23
Confidence Interval (2-Sided) 90%
-0.11 to 0.58
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.209
Estimation Comments [Not Specified]
Hide Statistical Analysis 49
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 75 mg
Comments Change at Week 2, RAM of Right Hands
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.22
Confidence Interval (2-Sided) 90%
-0.06 to 0.51
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.170
Estimation Comments [Not Specified]
Hide Statistical Analysis 50
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 300 mg
Comments Change at Week 2, RAM of Right Hands
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.11
Confidence Interval (2-Sided) 90%
-0.12 to 0.35
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.141
Estimation Comments [Not Specified]
Hide Statistical Analysis 51
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 75 mg
Comments Change at Week 7, RAM of Right Hands
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.06
Confidence Interval (2-Sided) 90%
-0.41 to 0.28
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.204
Estimation Comments [Not Specified]
Hide Statistical Analysis 52
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 300 mg
Comments Change at Week 7, RAM of Right Hands
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.00
Confidence Interval (2-Sided) 90%
-0.29 to 0.29
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.172
Estimation Comments [Not Specified]
Hide Statistical Analysis 53
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 75 mg
Comments Change at Week 12, RAM of Right Hands
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.19
Confidence Interval (2-Sided) 90%
-0.12 to 0.51
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.187
Estimation Comments [Not Specified]
Hide Statistical Analysis 54
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 300 mg
Comments Change at Week 12, RAM of Right Hands
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.05
Confidence Interval (2-Sided) 90%
-0.31 to 0.21
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.156
Estimation Comments [Not Specified]
Hide Statistical Analysis 55
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-831 75 mg
Comments Change at Week 2, RAM of Left Hands
Type of Statistical Test Superiority
Comments