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Trial record 94 of 2983 for:    Schizophrenia

Pediatric Schizophrenia Efficacy and Safety Study

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: NCT01911429
Recruitment Status : Completed
First Posted : July 30, 2013
Results First Posted : March 22, 2017
Last Update Posted : April 18, 2017
Sponsor:
Information provided by (Responsible Party):
Sunovion

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Schizophrenia
Interventions Drug: Lurasidone 40 mg
Drug: Lurasidone 80 mg
Drug: Placebo 40 or 80 mg
Enrollment 327
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lurasidone 40 mg Lurasidone 80 mg Placebo
Hide Arm/Group Description

Lurasidone 40 mg once daily

Lurasidone 40 mg: Lurasidone 40 mg once daily

Lurasidone 80 mg once daily

Lurasidone 80 mg: Lurasidone 80 mg once daily Subjects received lurasidone 40/mg day from Days 1-3, and 80mg/day from days 4 to Week 6 visit

Placebo 40 or 80 mg once daily

Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily

Period Title: Overall Study
Started 108 106 [1] 113 [2]
Completed 96 96 93
Not Completed 12 10 20
Reason Not Completed
Adverse Event             5             3             9
Lack of Efficacy             1             2             4
Lost to Follow-up             0             0             1
Protocol Violation             0             0             1
Withdrawal by Subject             5             5             4
Accidental randomization             0             0             1
subject left study             1             0             0
[1]
Subjects received lurasidone 40/mg day from Days 1-3, and 80mg/day from days 4 to Week 6 visit
[2]
one subject randomized to Placebo group was never dosed for study medication, making the total 112
Arm/Group Title Lurasidone 40 mg Lurasidone 80 mg Placebo Total
Hide Arm/Group Description

Lurasidone 40 mg once daily

Lurasidone 40 mg: Lurasidone 40 mg once daily

Lurasidone 80 mg once daily

Lurasidone 80 mg: Lurasidone 80 mg once daily

Placebo 40 or 80 mg once daily

Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily

Total of all reporting groups
Overall Number of Baseline Participants 110 104 112 326
Hide Baseline Analysis Population Description
two subjects from the lurasidone 80mg (originally 106) group transferred to the lurasidone 40 mg (originally 108) group
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 110 participants 104 participants 112 participants 326 participants
<=18 years
110
 100.0%
104
 100.0%
112
 100.0%
326
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 110 participants 104 participants 112 participants 326 participants
15.5  (1.33) 15.3  (1.35) 15.3  (1.37) 15.4  (1.35)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 110 participants 104 participants 112 participants 326 participants
13-15 years old
50
  45.5%
55
  52.9%
55
  49.1%
160
  49.1%
16-17 years old
60
  54.5%
49
  47.1%
57
  50.9%
166
  50.9%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 110 participants 104 participants 112 participants 326 participants
Female
67
  60.9%
70
  67.3%
71
  63.4%
208
  63.8%
Male
43
  39.1%
34
  32.7%
41
  36.6%
118
  36.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 110 participants 104 participants 112 participants 326 participants
Hispanic or Latino
13
  11.8%
18
  17.3%
13
  11.6%
44
  13.5%
Not Hispanic or Latino
97
  88.2%
86
  82.7%
99
  88.4%
282
  86.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 110 participants 104 participants 112 participants 326 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
6
   5.5%
4
   3.8%
5
   4.5%
15
   4.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
20
  18.2%
18
  17.3%
22
  19.6%
60
  18.4%
White
73
  66.4%
73
  70.2%
74
  66.1%
220
  67.5%
More than one race
11
  10.0%
9
   8.7%
11
   9.8%
31
   9.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 110 participants 104 participants 112 participants 326 participants
North America 38 35 37 110
South America 9 8 9 26
Europe 5 57 61 123
Southeast Asia 2 1 1 4
East Asia 2 1 1 4
Baseline BMI Percentile  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 110 participants 104 participants 112 participants 326 participants
< 3th percentile 0 1 1 2
> 3th to 85th percentile 74 65 72 211
>97th percentile 6 6 8 20
Baseline BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 110 participants 104 participants 112 participants 326 participants
22.38  (3.262) 22.56  (3.497) 22.52  (3.606) 22.48  (3.448)
Baseline weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 110 participants 104 participants 112 participants 326 participants
63.5  (12.39) 63.9  (12.88) 64.0  (11.88) 63.8  (12.34)
DSM-IV diagnosis of Schizophrenia  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 110 participants 104 participants 112 participants 326 participants
295.10 schizophrenia, disorganized type
13
  11.8%
6
   5.8%
7
   6.3%
26
   8.0%
295.30 schizophrenia, paranoid type
88
  80.0%
81
  77.9%
85
  75.9%
254
  77.9%
295.90 schizophrenia, undifferentiated type
9
   8.2%
17
  16.3%
20
  17.9%
46
  14.1%
1.Primary Outcome
Title Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6.
Hide Description

PANNS total score: Changes from baseline over time - mixed model for repeated measures at week 6 -PANSS total score may range from 30 to 210- Higher values of PANSS total score represent greater severity of illness

LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures with fixed effects terms for treatment, visit (as a categorical variable), pooled country, age strata, PANSS total score at baseline, and treatment-by-visit interaction.

Time Frame Baseline to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population includes all randomized subjects who receive at least one dose of study medication and have at least one post-baseline assessment in any efficacy variable.
Arm/Group Title Lurasidone 40 mg Lurasidone 80 mg Placebo
Hide Arm/Group Description:

Lurasidone 40 mg once daily

Lurasidone 40 mg: Lurasidone 40 mg once daily

Lurasidone 80 mg once daily

Lurasidone 80 mg: Lurasidone 80 mg once daily

Placebo 40 or 80 mg once daily

Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily

Overall Number of Participants Analyzed 108 106 112
Mean (Standard Deviation)
Unit of Measure: units on a scale
baseline 94.5  (10.97) 94.0  (11.12) 92.8  (11.08)
Week 6 -18.6  (1.59) -18.3  (1.60) -10.5  (1.59)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lurasidone 40 mg, Placebo
Comments

The sample size was estimated to provide at least 85% power to reject at least one of the null hypotheses of no difference between placebo and lurasidone doses.

LS Mean, LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM).

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method LS mean difference (SE)
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference (SE)
Estimated Value -8.0
Confidence Interval (2-Sided) 95%
-12.4 to -3.7
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lurasidone 80 mg, Placebo
Comments

The sample size was estimated to provide at least 85% power to reject at least one of the null hypotheses of no difference between placebo and lurasidone doses.

LS Mean, LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM).

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments [Not Specified]
Method LS mean difference (SE)
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference (SE)
Estimated Value -7.7
Confidence Interval (2-Sided) 95%
-12.1 to -3.4
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale
Hide Description

Clinical Global Impression severity (CGI-S): Changes from baseline over time-mixed model for repeated measures- scale from 1-7 - 1=normal, not at all ill; 7=among the most extremely ill patients.

LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures with fixed effects terms for treatment, visit (as a categorical variable), pooled country, age strata, CGIS at baseline, and treatment-by-visit interaction.

Time Frame baseline, week 6
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population includes all randomized subjects who receive at least one dose of study medication and have at least one post-baseline assessment in any efficacy variable
Arm/Group Title Lurasidone 40 mg Lurasidone 80 mg Placebo
Hide Arm/Group Description:

Lurasidone 40 mg once daily

Lurasidone 40 mg: Lurasidone 40 mg once daily

Lurasidone 80 mg once daily

Lurasidone 80 mg: Lurasidone 80 mg once daily

Placebo 40 or 80 mg once daily

Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily

Overall Number of Participants Analyzed 108 106 112
Mean (Standard Deviation)
Unit of Measure: units on a scale
baseline 4.9  (0.62) 4.8  (0.66) 4.8  (0.61)
week 6 -0.97  (0.093) -0.92  (0.093) -0.50  (0.094)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lurasidone 40 mg, Placebo
Comments LS Mean, LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method LS mean difference (SE)
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference (SE)
Estimated Value -0.47
Confidence Interval (2-Sided) 95%
-0.73 to -0.22
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lurasidone 80 mg, Placebo
Comments LS Mean, LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0015
Comments [Not Specified]
Method LS mean difference (SE)
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference (SE)
Estimated Value -0.42
Confidence Interval (2-Sided) 95%
-0.67 to -0.16
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in PANSS Positive Subscale Scores
Hide Description

PANSS positive subscale score: changes from baseline over time - mixed model for repeated measures –Positive subscale (range 7-49): sum of Items P1 to P7 in the positive subscale - Higher values of PANSS Positive Subscale Score represent greater severity of illness

LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures with fixed effects terms for treatment, visit (as a categorical variable), pooled country, age strata, corresponding PANSS subscale score at baseline, and treatment-by-visit interaction.

Time Frame baseline, week 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Lurasidone 40 mg Lurasidone 80 mg Placebo
Hide Arm/Group Description:

Lurasidone 40 mg once daily

Lurasidone 40 mg: Lurasidone 40 mg once daily

Lurasidone 80 mg once daily

Lurasidone 80 mg: Lurasidone 80 mg once daily

Placebo 40 or 80 mg once daily

Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily

Overall Number of Participants Analyzed 108 106 112
Mean (Standard Deviation)
Unit of Measure: units on a scale
baseline 24.1  (3.96) 24.0  (4.08) 23.4  (3.75)
week 6 -6.3  (0.51) -6.3  (0.51) -3.1  (0.51)
4.Secondary Outcome
Title Change From Baseline in PANSS Positive, Negative Subscale Scores
Hide Description

PANSS Negative subscale score: changes form baseline over time - Mixed model for repeated measures - – Negative subscale (range 7-49): sum of Items N1 to N7 in the negative subscale - Higher values of PANSS Negative Subscale Score represent greater severity of illness

LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures with fixed effects terms for treatment, visit (as a categorical variable), pooled country, age strata, corresponding PANSS subscale score at baseline, and treatment-by-visit interaction.

Time Frame baseline, week 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Lurasidone 40 mg Lurasidone 80 mg Placebo
Hide Arm/Group Description:

Lurasidone 40 mg once daily

Lurasidone 40 mg: Lurasidone 40 mg once daily

Lurasidone 80 mg once daily

Lurasidone 80 mg: Lurasidone 80 mg once daily

Placebo 40 or 80 mg once daily

Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily

Overall Number of Participants Analyzed 108 106 112
Mean (Standard Deviation)
Unit of Measure: units on a scale
baseline 24.2  (4.32) 24.5  (4.37) 24.4  (4.01)
week 6 -4.0  (0.48) -3.8  (0.49) -2.3  (0.49)
5.Secondary Outcome
Title Proportion of Responders, Where Response is Based on ≥ 20% Improvement From Baseline in PANSS Total Score at Week 6
Hide Description PANSS responder analysis over time: achieving >= 20% reduction from baseline
Time Frame week 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Lurasidone 40 mg Lurasidone 80 mg Placebo
Hide Arm/Group Description:

Lurasidone 40 mg once daily

Lurasidone 40 mg: Lurasidone 40 mg once daily

Lurasidone 80 mg once daily

Lurasidone 80 mg: Lurasidone 80 mg once daily

Placebo 40 or 80 mg once daily

Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily

Overall Number of Participants Analyzed 108 106 112
Measure Type: Number
Unit of Measure: number of participants
69 47 69
6.Secondary Outcome
Title Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q)
Hide Description

PQ-LES-Q percentage maximum possible score: summary statistics over time - PQ-LES-Q % maximum possible score can range from 0% to 100%. Higher scores indicate better quality of life.

LS Mean and SE for change from baseline are from an ANCOVA model including factors of treatment, pooled country and age group (stratification factor), and corresponding Baseline score as covariate and LOCF approach.

Time Frame baseline, week 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Lurasidone 40 mg Lurasidone 80 mg Placebo
Hide Arm/Group Description:

Lurasidone 40 mg once daily

Lurasidone 40 mg: Lurasidone 40 mg once daily

Lurasidone 80 mg once daily

Lurasidone 80 mg: Lurasidone 80 mg once daily

Placebo 40 or 80 mg once daily

Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily

Overall Number of Participants Analyzed 108 106 112
Mean (Standard Deviation)
Unit of Measure: units on a scale
baseline 51.3  (17.26) 53.6  (18.50) 52.5  (15.67)
week 6 5.6  (1.28) 6.1  (1.30) 0.3  (1.24)
7.Secondary Outcome
Title Change From Baseline in Clinician-rated Children’s Global Assessment Scale (CGAS)
Hide Description

Clinician-rated Children’s Global Assessment Scale (CGAS) score: summary statistics over time - CGAS is a numeric scale (1 through 100) , where 1 represents the most impaired functioning and 100, superior functioning

LS Mean and SE for change from baseline are from an ANCOVA model including factors of treatment, pooled country and age group (stratification factor), and corresponding Baseline score as covariate and LOCF approach.

Time Frame baseline, week 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Lurasidone 40 mg Lurasidone 80 mg Placebo
Hide Arm/Group Description:

Lurasidone 40 mg once daily

Lurasidone 40 mg: Lurasidone 40 mg once daily

Lurasidone 80 mg once daily

Lurasidone 80 mg: Lurasidone 80 mg once daily

Placebo 40 or 80 mg once daily

Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily

Overall Number of Participants Analyzed 108 106 112
Mean (Standard Deviation)
Unit of Measure: units on a scale
baseline 44.2  (9.33) 44.6  (8.11) 43.9  (8.34)
week 6 11.3  (1.16) 11.9  (1.18) 7.5  (1.17)
8.Secondary Outcome
Title Change From Baseline in PANSS General Psychopathology Subscale Scores
Hide Description

PANSS general psychopathology subscale score: changes from baseline over time - mixed model for repeated measures -– General psychopathology (range 16-112): sum of Items G1 to G16 in the general psychopathology subscale -Higher values of PANSS General Psychopathology Subscale Score represent greater severity of illness

LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures with fixed effects terms for treatment, visit (as a categorical variable), pooled country, age strata, corresponding PANSS subscale score at baseline, and treatment-by-visit interaction.

Time Frame baseline, week 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Lurasidone 40 mg Lurasidone 80 mg Placebo
Hide Arm/Group Description:

Lurasidone 40 mg once daily

Lurasidone 40 mg: Lurasidone 40 mg once daily

Lurasidone 80 mg once daily

Lurasidone 80 mg: Lurasidone 80 mg once daily

Placebo 40 or 80 mg once daily

Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily

Overall Number of Participants Analyzed 108 106 112
Mean (Standard Deviation)
Unit of Measure: units on a scale
baseline 46.2  (6.65) 45.5  (7.03) 45.0  (6.94)
week 6 -8.1  (0.80) -8.1  (0.81) -5.3  (0.80)
9.Secondary Outcome
Title Change From Baseline in PANSS Excitability Subscale Scores
Hide Description

Excitability subscale scores (range 4-28): consists of the following four items from the PANSS: excitement, hostility, uncooperativeness, and poor impulse control

  • Higher values of PANSS Excitability Subscale Score represent greater severity of illness

LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures with fixed effects terms for treatment, visit (as a categorical variable), pooled country, age strata, corresponding PANSS subscale score at baseline, and treatment-by-visit interaction.

Time Frame baseline, week 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Lurasidone 40 mg Lurasidone 80 mg Placebo
Hide Arm/Group Description:

Lurasidone 40 mg once daily

Lurasidone 40 mg: Lurasidone 40 mg once daily

Lurasidone 80 mg once daily

Lurasidone 80 mg: Lurasidone 80 mg once daily

Placebo 40 or 80 mg once daily

Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily

Overall Number of Participants Analyzed 108 106 112
Mean (Standard Deviation)
Unit of Measure: units on a scale
baseline 10.8  (2.91) 11.1  (3.07) 10.7  (3.23)
week 6 -0.6  (0.33) -1.7  (0.33) -2.4  (0.33)
Time Frame Treatment-emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter into the extension study or early discontinue during the double blind study), or through the last study day of the doubleblind period for subjects continuing into the extension study.
Adverse Event Reporting Description AEs were collected from the time the informed consent is signed to the end of the study. Non-leading questions were used to ask subjects about the possible occurrence of AEs. The investigator then established a diagnosis of the event based on signed, symptoms, and/or other clinical information. Please note that two subjects from the lurasidone 80mg (originally 106) group transferred to the lurasidone 40 mg (originally 108) group
 
Arm/Group Title Lurasidone 40 mg Lurasidone 80 mg Placebo
Hide Arm/Group Description

Lurasidone 40 mg once daily

Lurasidone 40 mg: Lurasidone 40 mg once daily

Lurasidone 80 mg once daily

Lurasidone 80 mg: Lurasidone 80 mg once daily

Placebo 40 or 80 mg once daily

Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily

All-Cause Mortality
Lurasidone 40 mg Lurasidone 80 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lurasidone 40 mg Lurasidone 80 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/110 (3.64%)      2/104 (1.92%)      9/112 (8.04%)    
Gastrointestinal disorders       
Diarrhoea  1  1/110 (0.91%)  1 0/104 (0.00%)  0 0/112 (0.00%)  0
Psychiatric disorders       
schizophrenia  1  2/110 (1.82%)  2 2/104 (1.92%)  2 7/112 (6.25%)  7
Homicidal Ideation  1  1/110 (0.91%)  0/104 (0.00%)  0 0/112 (0.00%)  0
Psychotic Disorder  1  0/110 (0.00%)  0 0/104 (0.00%)  0 1/112 (0.89%)  1
Suicidal Ideation  1  0/110 (0.00%)  0 0/104 (0.00%)  0 1/112 (0.89%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lurasidone 40 mg Lurasidone 80 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   70/110 (63.64%)      67/104 (64.42%)      53/112 (47.32%)    
Gastrointestinal disorders       
Nausea  1  14/110 (12.73%)  20 15/104 (14.42%)  18 3/112 (2.68%)  4
Vomiting  1  9/110 (8.18%)  10 7/104 (6.73%)  8 2/112 (1.79%)  2
Nervous system disorders       
Somnolence  1  10/110 (9.09%)  10 12/104 (11.54%)  12 6/112 (5.36%)  8
Headache  1  7/110 (6.36%)  8 11/104 (10.58%)  15 14/112 (12.50%)  19
Akathisia  1  10/110 (9.09%)  12 9/104 (8.65%)  10 2/112 (1.79%)  2
Sedation  1  6/110 (5.45%)  6 2/104 (1.92%)  3 2/112 (1.79%)  2
Psychiatric disorders       
Insomnia  1  6/110 (5.45%)  6 7/104 (6.73%)  8 10/112 (8.93%)  12
Agitation  1  5/110 (4.55%)  7 6/104 (5.77%)  6 5/112 (4.46%)  5
Anxiety  1  11/110 (10.00%)  14 3/104 (2.88%)  3 9/112 (8.04%)  11
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
In the event the Study is part of a multi-center study, the first publication of the results of the study shall be made in conjunction with the results of other participating study sites as a multi-center publication; provided however, if a multi-center publication is not forthcoming within twenty-four (24) months following completion of the Study at all sites, Institution and Investigator shall be free to publish.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: CNS Medical Director
Organization: Sunovion Pharmaceuticals Inc.
Phone: 1-866-503-6351
EMail: clinicaltrialsdisclosure@sunovion.com
Layout table for additonal information
Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT01911429     History of Changes
Other Study ID Numbers: D1050301
2013-001695-38 ( EudraCT Number )
First Submitted: July 22, 2013
First Posted: July 30, 2013
Results First Submitted: December 1, 2016
Results First Posted: March 22, 2017
Last Update Posted: April 18, 2017