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A Randomized, Double-Blind, Placebo Controlled, Two-Period Cross-Over, Proof of Activity Study to Evaluate the Effects of TAK-041 on Motivational Anhedonia as Add-On to Antipsychotics in Participants With Stable Schizophrenia

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ClinicalTrials.gov Identifier: NCT03319953
Recruitment Status : Completed
First Posted : October 24, 2017
Results First Posted : February 9, 2021
Last Update Posted : March 19, 2021
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
Neurocrine Biosciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Stable Schizophrenia
Interventions Drug: TAK-041
Drug: Placebo
Drug: Second Generation Antipsychotics (SGA)
Enrollment 23
Recruitment Details Participants took part in the study at single investigative sites in United Kingdom from 21 December 2017 to 06 November 2019.
Pre-assignment Details  
Arm/Group Title Treatment Sequence 1: TAK-041 40 mg/Placebo + Antipsychotics Treatment Sequence 2: Placebo/TAK-041 40 mg + Antipsychotics Treatment Sequence 3: TAK-041 160 mg/Placebo + Antipsychotics Treatment Sequence 4: Placebo/TAK-041 160 mg + Antipsychotics
Hide Arm/Group Description TAK-041 40 milligram (mg), suspension, orally on Day 1 of Treatment Period 1, followed by 35 days wash-out Period, followed by TAK-041 placebo-matching, suspension, orally on Day 1 of Treatment Period 2. All participants received a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period. TAK-041 placebo-matching, suspension, orally on Day 1 of Treatment Period 1, followed by 35 days Wash-out Period, followed by TAK-041 40 mg, suspension, orally on Day 1 of Treatment Period 2. All participants received a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period. TAK-041 160 mg, suspension, orally on Day 1 of Treatment Period 1, followed by 35 days Wash-out Period, followed by TAK-041 placebo-matching, suspension, orally on Day 1 of Treatment Period 2. All participants received stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period. TAK-041 placebo-matching, suspension, orally on Day 1 of Treatment Period 1, followed by 35 days Wash-out Period, followed by TAK-041 160 mg, suspension, orally on Day 1 of Treatment Period 2. All participants received stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.
Period Title: Period 1 (Day 1 to 14)
Started 3 4 9 7
Completed [1] 3 4 9 7
Not Completed 0 0 0 0
[1]
Completed = Participants who completed study treatment.
Period Title: Washout Period (Day 15 to 49)
Started 3 4 9 7
Completed 3 4 9 7
Not Completed 0 0 0 0
Period Title: Period 2 (Day 49 to 154)
Started 3 4 9 7
Treated [1] 2 4 8 6
Completed [2] 2 4 8 6
Not Completed 1 0 1 1
Reason Not Completed
Withdrawal by Subject             1             0             0             0
Reason not Specified             0             0             1             1
[1]
3 participants discontinued before receiving their respective treatment, per sequence, in Period 2.
[2]
Completed = Participants who completed study treatment.
Arm/Group Title Treatment Sequence 1: TAK-041 40 mg/Placebo + Antipsychotics Treatment Sequence 2: Placebo/TAK-041 40 mg + Antipsychotics Treatment Sequence 3: TAK-041 160 mg/Placebo + Antipsychotics Treatment Sequence 4: Placebo/TAK-041 160 mg + Antipsychotics Total
Hide Arm/Group Description TAK-041 40 milligram (mg), suspension, orally on Day 1 of Treatment Period 1, followed by 35 days wash-out Period, followed by TAK-041 placebo-matching, suspension, orally on Day 1 of Treatment Period 2. All participants received a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period. TAK-041 placebo-matching, suspension, orally on Day 1 of Treatment Period 1, followed by 35 days Wash-out Period, followed by TAK-041 40 mg, suspension, orally on Day 1 of Treatment Period 2. All participants received a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period. TAK-041 160 mg, suspension, orally on Day 1 of Treatment Period 1, followed by 35 days Wash-out Period, followed by TAK-041 placebo-matching, suspension, orally on Day 1 of Treatment Period 2. All participants received stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period. TAK-041 placebo-matching, suspension, orally on Day 1 of Treatment Period 1, followed by 35 days Wash-out Period, followed by TAK-041 160 mg, suspension, orally on Day 1 of Treatment Period 2. All participants received stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period. Total of all reporting groups
Overall Number of Baseline Participants 3 4 9 7 23
Hide Baseline Analysis Population Description
All randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 4 participants 9 participants 7 participants 23 participants
42.0  (16.5) 39.3  (16.1) 46.8  (12.1) 43.4  (9.6) 43.8  (12.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 4 participants 9 participants 7 participants 23 participants
Female
0
   0.0%
2
  50.0%
2
  22.2%
2
  28.6%
6
  26.1%
Male
3
 100.0%
2
  50.0%
7
  77.8%
5
  71.4%
17
  73.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 4 participants 9 participants 7 participants 23 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
3
 100.0%
4
 100.0%
9
 100.0%
7
 100.0%
23
 100.0%
Unknown or Not Reported
0
   0.0%
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 3 participants 4 participants 9 participants 7 participants 23 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
1
  11.1%
0
   0.0%
1
   4.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
 100.0%
3
  75.0%
4
  44.4%
6
  85.7%
16
  69.6%
White
0
   0.0%
1
  25.0%
4
  44.4%
0
   0.0%
5
  21.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
1
  14.3%
1
   4.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Change From Baseline in the Brief Assessment of Cognition in Schizophrenia (BACS) Composite Score at Second Testing After TAK-041 Administration
Hide Description BACS is a reliable and sensitive measure of cognitive function in schizophrenia. The BACS consists of items across six subtests: Verbal Memory, Digit Sequencing, Token Motor, Verbal Fluency, Symbol Coding, and Tower of London. The subtest scale scores were used to compute a composite BACS t-score of 50 (20) is the mean (standard deviation) of a relevant index population. Higher values indicate better performance. Bayesian normal linear model was used for analysis.
Time Frame Baseline (Day -1) and Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacodynamic (PD) Analysis Set included all participants who received at least 1 dose of study drug and had at least 1 evaluable primary or exploratory PD measurement. Number analyzed is the number of participants with data available for analyses.
Arm/Group Title Placebo TAK-041 40 mg TAK-041 160 mg
Hide Arm/Group Description:
TAK-041 placebo-matching, suspension, orally on Day 1 of Treatment Period 1 or 2. All participants took a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.
TAK-041 40 mg, suspension, orally on Day 1 of Treatment Period 1 or 2. All participants took a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.
TAK-041 160 mg, suspension, orally on Day 1 of Treatment Period 1 or 2. All participants took a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.
Overall Number of Participants Analyzed 21 7 15
Mean (Standard Deviation)
Unit of Measure: t-scale
Baseline Number Analyzed 21 participants 7 participants 15 participants
29.72  (12.867) 27.35  (12.753) 27.89  (8.214)
Day 14 Number Analyzed 21 participants 6 participants 14 participants
2.28  (6.963) 5.35  (6.944) 1.31  (5.618)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-041 40 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2079
Comments Bayesian method was used to calculate the posterior probability. High posterior probability of a difference between TAK-041 and placebo >2.0.
Method Bayesian Normal Linear Model
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-041 160 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0633
Comments Bayesian method was used to calculate the posterior probability. High posterior probability of a difference between TAK-041 and placebo >2.0.
Method Bayesian Normal Linear Model
Comments [Not Specified]
2.Primary Outcome
Title Blood-Oxygen-Level-Dependent (BOLD) Signal in the Average Ventral Striatum (VS) Region of Interest (ROI) Activation in the Monetary Incentive Delay (MID) Reward Task at First Testing After TAK-041 Administration
Hide Description Blood-oxygen-level-dependent imaging, or BOLD-contrast imaging, is a method used in functional magnetic resonance imaging (fMRI) to observe different areas of the brain or other organs, which are found to be active at any given time. The MID task is a reward anticipation paradigm that robustly engages the VS, a key area associated with coding incentive reward. Dysfunctional processing of reward information is associated with motivational impairments in schizophrenia. Motivational impairment is a key aspect of negative symptoms, and has been associated with reduced activity in the VS. Any change in BOLD signal that comes in fMRI is reported.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
PD Analysis Set included all participants who received at least 1 dose of study drug and had at least 1 evaluable primary or exploratory PD measurement. Overall number of participants analyzed is the number of participants with data available for analyses.
Arm/Group Title Placebo TAK-041 40 mg TAK-041 160 mg
Hide Arm/Group Description:
TAK-041 placebo-matching, suspension, orally on Day 1 of Treatment Period 1 or 2. All participants took a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.
TAK-041 40 mg, suspension, orally on Day 1 of Treatment Period 1 or 2. All participants took a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.
TAK-041 160 mg, suspension, orally on Day 1 of Treatment Period 1 or 2. All participants took a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.
Overall Number of Participants Analyzed 20 6 13
Mean (Standard Deviation)
Unit of Measure: BOLD signal
0.23  (0.396) 0.23  (0.202) 0.03  (0.458)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-041 40 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1706
Comments Bayesian method was used to calculate the posterior probability. High posterior probability of a difference between TAK-041 and placebo >0.09.
Method Bayesian Normal Linear Model
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-041 160 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0373
Comments Bayesian method was used to calculate the posterior probability. High posterior probability of a difference between TAK-041 and placebo >0.09.
Method Bayesian Normal Linear Model
Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)
Hide Description An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.
Time Frame From the first dose of study drug up to 77 days after last dose of study drug (Up to Day 154)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least 1 dose of study drug.
Arm/Group Title Placebo TAK-041 40 mg TAK-041 160 mg
Hide Arm/Group Description:
TAK-041 placebo-matching, suspension, orally on Day 1 of Treatment Period 1 or 2. All participants took a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.
TAK-041 40 mg, suspension, orally on Day 1 of Treatment Period 1 or 2. All participants took a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.
TAK-041 160 mg, suspension, orally on Day 1 of Treatment Period 1 or 2. All participants took a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.
Overall Number of Participants Analyzed 21 7 15
Measure Type: Number
Unit of Measure: percentage of participants
57.1 71.4 53.3
4.Secondary Outcome
Title Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose
Hide Description Clinical Laboratory parameters included tests for chemistry, hematology and urinalysis. Markedly abnormal values during treatment period were categorized as: alanine aminotransferase (ALT)>3.0 U/L*upper limit of normal(ULN),albumin<25 g/L*lower limit of normal(LLN), alkaline phosphatase >3.0 U/L*ULN, aspartate aminotransferase >3.0 U/L*ULN, bilirubin >34.2 umol/L*ULN, calcium <1.75 mmol/L, >2.88 mmol/L, chloride <75 mmol/L, >126 mmol/L, creatinine >177umol/L, gamma glutamyl transferase >3 U/L*ULN, glucose <2.8 mmol/L, >19.4 mmol/L, potassium<3 mmol/L, >6 mmol/L, sodium <130 mmol/L, >150 mmol/L,Urea <130 mmol/L, erythrocytes <0.8*LLN >1.2*ULN, hematocrit <0.8*LLN, >1.2*ULN, hemoglobin <0.8 g/L*LLN, >1.2 g/L*ULN, leukocytes <0.5 (10^9/L)*LLN, >1.5 (10^9/L)*ULN, platelets <75(10^9/L), >600(10^9/L).
Time Frame From the first dose of study drug up to 77 days after last dose of study drug (Up to Day 154)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least 1 dose of study drug.
Arm/Group Title Placebo TAK-041 40 mg TAK-041 160 mg
Hide Arm/Group Description:
TAK-041 placebo-matching, suspension, orally on Day 1 of Treatment Period 1 or 2. All participants took a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.
TAK-041 40 mg, suspension, orally on Day 1 of Treatment Period 1 or 2. All participants took a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.
TAK-041 160 mg, suspension, orally on Day 1 of Treatment Period 1 or 2. All participants took a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.
Overall Number of Participants Analyzed 21 7 15
Measure Type: Number
Unit of Measure: percentage of participants
0 0 0
5.Secondary Outcome
Title Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements At Least Once Post Dose
Hide Description Vital signs included oral body temperature measurement, supine and standing blood pressure, respiration rate, and pulse. Pulse and blood pressure were measured after 5 minutes supine and again at 1 and 3 minutes after standing. The markedly abnormal value (MAV) criteria for vital signs included systolic blood pressure < 85 mmHg, > 180 mmHg; diastolic blood pressure < 50 mmHg, > 110 mmHg; pulse < 50 beats/min, > 120 beats/min; temperature < 35.6 C > 37.7 C.
Time Frame From the first dose of study drug up to 77 days after last dose of study drug (Up to Day 154)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least 1 dose of study drug. Only categories with at least one participant are reported.
Arm/Group Title Placebo TAK-041 40 mg TAK-041 160 mg
Hide Arm/Group Description:
TAK-041 placebo-matching, suspension, orally on Day 1 of Treatment Period 1 or 2. All participants took a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.
TAK-041 40 mg, suspension, orally on Day 1 of Treatment Period 1 or 2. All participants took a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.
TAK-041 160 mg, suspension, orally on Day 1 of Treatment Period 1 or 2. All participants took a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.
Overall Number of Participants Analyzed 21 7 15
Measure Type: Number
Unit of Measure: percentage of participants
<35.6 C 0 0 6.7
>37.7 C 4.8 0 0
6.Secondary Outcome
Title Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) at Least Once Post Dose
Hide Description The markedly abnormal value (MAV) criteria for 12-lead ECG parameters included ECG Mean Heart Rate < 50 beats/min, > 120 beats/min; PR Interval, Aggregate <= 80 msec, >= 200 msec; QRS Duration, Aggregate <= 80 msec, >= 180 msec; QTcB Interval, Aggregate <= 300 msec, >= 500 msec OR (>= 30 msec change from baseline and >= 450 msec); QTcF Interval, Aggregate <= 300 msec, >= 500 msec OR (>= 30 msec change from baseline and >= 450 msec).
Time Frame From the first dose of study drug up to 77 days after last dose of study drug (Up to Day 154)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least 1 dose of study drug. Categories with at least one participant are reported. Number analyzed is the number of participants with data available for analyses.
Arm/Group Title Placebo TAK-041 40 mg TAK-041 160 mg
Hide Arm/Group Description:
TAK-041 placebo-matching, suspension, orally on Day 1 of Treatment Period 1 or 2. All participants took a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.
TAK-041 40 mg, suspension, orally on Day 1 of Treatment Period 1 or 2. All participants took a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.
TAK-041 160 mg, suspension, orally on Day 1 of Treatment Period 1 or 2. All participants took a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.
Overall Number of Participants Analyzed 21 7 15
Measure Type: Number
Unit of Measure: percentage of participants
ECG Mean Heart Rate: <50 beats per minute Number Analyzed 19 participants 5 participants 15 participants
0 0 6.7
PR Interval: >=200 milliseconds Number Analyzed 19 participants 5 participants 15 participants
10.5 20.0 13.3
QRS Duration: <=80 milliseconds Number Analyzed 19 participants 5 participants 15 participants
36.8 20.0 33.3
7.Secondary Outcome
Title Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS)
Hide Description Treatment-emergent suicidal ideation (SI) or suicidal behavior (SB) compared to baseline will be measured by an increase in suicidal ideation category (1-5 on the C-SSRS) or suicidal behavior category (6-10 on the C-SSRS) during treatment from the maximum suicidal ideation/behavior category at baseline, or any suicidal ideation/behavior during treatment if there is none at baseline. C-SSRS is used to assess whether participant experienced suicidal ideation (1: wish to be dead; 2: non-specific active suicidal thoughts; 3: active suicidal ideation with any methods (not plan) without intent to act; 4: active suicidal ideation with some intent to act, without specific plan; 5: active suicidal ideation with specific plan and intent) and suicidal behavior (6: actual attempt; 7: interrupted attempt; 8: aborted attempt; 9: preparatory acts or behavior; 10: suicidal behavior).
Time Frame Baseline (Day -1) and Days 14, 35 and 77
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least 1 dose of study drug. Only categories with at least one participant are reported. Number analyzed is the number of participants with data available for analyses.
Arm/Group Title Placebo TAK-041 40 mg TAK-041 160 mg
Hide Arm/Group Description:
TAK-041 placebo-matching, suspension, orally on Day 1 of Treatment Period 1 or 2. All participants took a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.
TAK-041 40 mg, suspension, orally on Day 1 of Treatment Period 1 or 2. All participants took a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.
TAK-041 160 mg, suspension, orally on Day 1 of Treatment Period 1 or 2. All participants took a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.
Overall Number of Participants Analyzed 21 7 15
Measure Type: Count of Participants
Unit of Measure: Participants
SI-Wish to be Dead, Day -1 Number Analyzed 21 participants 7 participants 15 participants
3
  14.3%
0
   0.0%
1
   6.7%
SI-Wish to be Dead, Day 14 Number Analyzed 21 participants 7 participants 14 participants
1
   4.8%
0
   0.0%
0
   0.0%
SI-Wish to be Dead, Day 77 Number Analyzed 10 participants 4 participants 6 participants
1
  10.0%
0
   0.0%
1
  16.7%
SB-Non-suicidal Self-injurious Behaviour, Day 77 Number Analyzed 0 participants 4 participants 6 participants
1
  25.0%
0
   0.0%
Time Frame From the first dose of study drug up to 77 days after last dose of study drug (Up to Day 154)
Adverse Event Reporting Description At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all participants who were enrolled and received at least 1 dose of study drug.
 
Arm/Group Title Placebo TAK-041 40 mg TAK-041 160 mg
Hide Arm/Group Description TAK-041 placebo-matching, suspension, orally on Day 1 of Treatment Period 1 or 2. All participants took a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period. TAK-041 40 mg, suspension, orally on Day 1 of Treatment Period 1 or 2. All participants took a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period. TAK-041 160 mg, suspension, orally on Day 1 of Treatment Period 1 or 2. All participants took a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.
All-Cause Mortality
Placebo TAK-041 40 mg TAK-041 160 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/7 (0.00%)   0/15 (0.00%) 
Hide Serious Adverse Events
Placebo TAK-041 40 mg TAK-041 160 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/7 (0.00%)   0/15 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo TAK-041 40 mg TAK-041 160 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   12/21 (57.14%)   5/7 (71.43%)   8/15 (53.33%) 
Blood and lymphatic system disorders       
Neutropenia  1  2/21 (9.52%)  0/7 (0.00%)  0/15 (0.00%) 
Gastrointestinal disorders       
Vomiting  1  1/21 (4.76%)  0/7 (0.00%)  1/15 (6.67%) 
Gastrooesophageal Reflux Disease  1  0/21 (0.00%)  0/7 (0.00%)  1/15 (6.67%) 
Nausea  1  1/21 (4.76%)  0/7 (0.00%)  0/15 (0.00%) 
General disorders       
Fatigue  1  2/21 (9.52%)  0/7 (0.00%)  1/15 (6.67%) 
Chest Pain  1  1/21 (4.76%)  0/7 (0.00%)  1/15 (6.67%) 
Catheter Site Pain  1  1/21 (4.76%)  0/7 (0.00%)  0/15 (0.00%) 
Infections and infestations       
Nasopharyngitis  1  3/21 (14.29%)  1/7 (14.29%)  0/15 (0.00%) 
Upper Respiratory Tract Infection  1  2/21 (9.52%)  0/7 (0.00%)  0/15 (0.00%) 
Pharyngitis  1  0/21 (0.00%)  0/7 (0.00%)  1/15 (6.67%) 
Injury, poisoning and procedural complications       
Fall  1  0/21 (0.00%)  0/7 (0.00%)  1/15 (6.67%) 
Muscle Strain  1  0/21 (0.00%)  0/7 (0.00%)  1/15 (6.67%) 
Procedural Headache  1  0/21 (0.00%)  1/7 (14.29%)  0/15 (0.00%) 
Investigations       
Alanine Aminotransferase Increased  1  0/21 (0.00%)  0/7 (0.00%)  1/15 (6.67%) 
Aspartate Aminotransferase Increased  1  0/21 (0.00%)  0/7 (0.00%)  1/15 (6.67%) 
Lymphocyte Count Decreased  1  0/21 (0.00%)  1/7 (14.29%)  0/15 (0.00%) 
Metabolism and nutrition disorders       
Hypokalaemia  1  0/21 (0.00%)  1/7 (14.29%)  0/15 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  1/21 (4.76%)  0/7 (0.00%)  1/15 (6.67%) 
Back Pain  1  0/21 (0.00%)  1/7 (14.29%)  1/15 (6.67%) 
Myalgia  1  2/21 (9.52%)  0/7 (0.00%)  0/15 (0.00%) 
Muscle Spasms  1  1/21 (4.76%)  0/7 (0.00%)  0/15 (0.00%) 
Neck Pain  1  0/21 (0.00%)  0/7 (0.00%)  1/15 (6.67%) 
Nervous system disorders       
Headache  1  2/21 (9.52%)  1/7 (14.29%)  1/15 (6.67%) 
Somnolence  1  1/21 (4.76%)  0/7 (0.00%)  1/15 (6.67%) 
Syncope  1  0/21 (0.00%)  0/7 (0.00%)  1/15 (6.67%) 
Psychiatric disorders       
Anxiety  1  1/21 (4.76%)  0/7 (0.00%)  0/15 (0.00%) 
Insomnia  1  1/21 (4.76%)  0/7 (0.00%)  0/15 (0.00%) 
Panic Attack  1  1/21 (4.76%)  0/7 (0.00%)  0/15 (0.00%) 
Paranoia  1  1/21 (4.76%)  0/7 (0.00%)  0/15 (0.00%) 
Schizophrenia  1  0/21 (0.00%)  0/7 (0.00%)  1/15 (6.67%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  0/21 (0.00%)  2/7 (28.57%)  0/15 (0.00%) 
Nasal Congestion  1  1/21 (4.76%)  0/7 (0.00%)  0/15 (0.00%) 
Oropharyngeal Pain  1  1/21 (4.76%)  0/7 (0.00%)  0/15 (0.00%) 
Rhinorrhoea  1  1/21 (4.76%)  0/7 (0.00%)  0/15 (0.00%) 
Skin and subcutaneous tissue disorders       
Dry Skin  1  1/21 (4.76%)  0/7 (0.00%)  0/15 (0.00%) 
Social circumstances       
Pregnancy Of Partner  1  1/21 (4.76%)  0/7 (0.00%)  0/15 (0.00%) 
1
Term from vocabulary, MedDRA:22.0
Indicates events were collected by systematic assessment
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.
Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Takeda
Phone: +1-877-825-3327
EMail: trialdisclosures@takeda.com
Layout table for additonal information
Responsible Party: Neurocrine Biosciences
ClinicalTrials.gov Identifier: NCT03319953    
Other Study ID Numbers: TAK-041-2001
U1111-1191-6915 ( Other Identifier: World Health Organisation )
2017-001084-20 ( EudraCT Number: European Medicines Agency )
17/YH/0195 ( Registry Identifier: NRES )
03319953 ( Registry Identifier: ClinicalTrials.gov )
First Submitted: October 20, 2017
First Posted: October 24, 2017
Results First Submitted: November 6, 2020
Results First Posted: February 9, 2021
Last Update Posted: March 19, 2021