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| ID | Type | Description | Link |
|---|---|---|---|
| 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 |
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| Name | Class |
|---|---|
| Takeda | INDUSTRY |
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The purpose of the study is to determine whether motivation/reward deficits observed in schizophrenia are attenuated and whether cognitive impairment associated with schizophrenia is improved by add-on TAK-041 administration to antipsychotics in participants with stable schizophrenia.
The drug being tested in this study is called TAK-041. TAK-041 is being tested to treat people who have stable schizophrenia. This study will look whether motivation/reward deficits observed in schizophrenia are attenuated and whether cognitive impairment associated with schizophrenia is improved in people who take TAK-041 in addition to standard care.
The study will enroll approximately 32 patients. Participants will be randomly assigned (by chance, like flipping a coin) in 1:1 ratio to one of the two treatment sequences -which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need) to receive either TAK-041 40 mg or Placebo first and then will be crossed over to receive the opposite Intervention.
All participants will be asked to take oral suspension on Day 1 of each Period. There will be a wash-out Period of 35 days between the dosing days in Period 1 and 2.
This single-center trial will be conducted in the United Kingdom. The overall time to participate in this study is approximately 126 to 154 days. Participants will make multiple visits to the clinic plus a final visit 77 days after receiving their last dose of drug for a follow-up assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Sequence 1: TAK-041 40 mg/Placebo + Antipsychotics | Experimental | TAK-041 40 milligram (mg), suspension, orally on Day 1 of Treatment Period 1, followed by 35 day 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. |
|
| Treatment Sequence 2: Placebo/TAK-041 40 mg + Antipsychotics | Experimental | 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. |
|
| Treatment Sequence 3: TAK-041 160 mg/Placebo + Antipsychotics | Experimental | 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. |
|
| Treatment Sequence 4: Placebo/TAK-041 160 mg + Antipsychotics |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-041 | Drug | TAK-041 suspension |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Brief Assessment of Cognition in Schizophrenia (BACS) Composite Score at Second Testing After TAK-041 Administration | 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. | Baseline (Day -1) and Day 14 |
| 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 | 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. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) | 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. | From the first dose of study drug up to 77 days after last dose of study drug (Up to Day 154) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director Clinical Science | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kings College London | London | SE58AF | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40817174 | Derived | Hawkins PCT, Schwarz AJ, Stone JM, Pepper F, Gilleen J, Gijsen S, Mazibuko N, Arkilo D, Yin W, Wu J, Khudyakov P, Behrje R, Rosen L, Posener J, Mehta MA, Laurenza A. The GPR139 agonist TAK-041 produces time-dependent alterations to cerebral blood flow and reward system function in patients with schizophrenia: a randomised placebo-controlled trial. Psychopharmacology (Berl). 2026 Apr;243(4):819-829. doi: 10.1007/s00213-025-06884-x. Epub 2025 Aug 16. |
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Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
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Participants took part in the study at single investigative sites in United Kingdom from 21 December 2017 to 06 November 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Sequence 1: TAK-041 40 mg/Placebo + Antipsychotics | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 (Day 1 to 14) |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 10, 2018 | Nov 6, 2020 |
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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. |
|
| Placebo | Drug | TAK-041 placebo-matching suspension |
|
| Second Generation Antipsychotics (SGA) | Drug | Second generation antipsychotics included risperidone, paliperidone, iloperidone, quetiapine, olanzapine, ziprasidone, asenapine and lurasidone. |
|
| Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose | 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). | From the first dose of study drug up to 77 days after last dose of study drug (Up to Day 154) |
| Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements At Least Once Post Dose | 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. | From the first dose of study drug up to 77 days after last dose of study drug (Up to Day 154) |
| Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) at Least Once Post Dose | 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). | From the first dose of study drug up to 77 days after last dose of study drug (Up to Day 154) |
| Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS) | 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). | Baseline (Day -1) and Days 14, 35 and 77 |
| FG001 | Treatment Sequence 2: Placebo/TAK-041 40 mg + Antipsychotics | 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. |
| FG002 | Treatment Sequence 3: TAK-041 160 mg/Placebo + Antipsychotics | 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. |
| FG003 | Treatment Sequence 4: Placebo/TAK-041 160 mg + Antipsychotics | 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. |
| COMPLETED | Completed = Participants who completed study treatment. |
|
| NOT COMPLETED |
|
| Washout Period (Day 15 to 49) |
|
| Period 2 (Day 49 to 154) |
|
|
All randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Sequence 1: TAK-041 40 mg/Placebo + Antipsychotics | 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. |
| BG001 | Treatment Sequence 2: Placebo/TAK-041 40 mg + Antipsychotics | 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. |
| BG002 | Treatment Sequence 3: TAK-041 160 mg/Placebo + Antipsychotics | 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. |
| BG003 | Treatment Sequence 4: Placebo/TAK-041 160 mg + Antipsychotics | 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. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in the Brief Assessment of Cognition in Schizophrenia (BACS) Composite Score at Second Testing After TAK-041 Administration | 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. | 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. | Posted | Mean | Standard Deviation | t-scale | Baseline (Day -1) and Day 14 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | BOLD signal | Day 1 |
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| Secondary | Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) | 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. | Safety analysis set included all participants who were enrolled and received at least 1 dose of study drug. | Posted | Number | percentage of participants | From the first dose of study drug up to 77 days after last dose of study drug (Up to Day 154) |
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| Secondary | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose | 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). | Safety analysis set included all participants who were enrolled and received at least 1 dose of study drug. | Posted | Number | percentage of participants | From the first dose of study drug up to 77 days after last dose of study drug (Up to Day 154) |
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| Secondary | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements At Least Once Post Dose | 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. | 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. | Posted | Number | percentage of participants | From the first dose of study drug up to 77 days after last dose of study drug (Up to Day 154) |
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| Secondary | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) at Least Once Post Dose | 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). | 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. | Posted | Number | percentage of participants | From the first dose of study drug up to 77 days after last dose of study drug (Up to Day 154) |
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| Secondary | Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS) | 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). | 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. | Posted | Count of Participants | Participants | Baseline (Day -1) and Days 14, 35 and 77 |
|
From the first dose of study drug up to 77 days after last dose of study drug (Up to Day 154)
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | 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. | 0 | 21 | 0 | 21 | 12 | 21 |
| EG001 | TAK-041 40 mg | 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. | 0 | 7 | 0 | 7 | 5 | 7 |
| EG002 | TAK-041 160 mg | 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. | 0 | 15 | 0 | 15 | 8 | 15 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA:22.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA:22.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA:22.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA:22.0 | Systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA:22.0 | Systematic Assessment |
| |
| Catheter Site Pain | General disorders | MedDRA:22.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA:22.0 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA:22.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA:22.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA:22.0 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA:22.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA:22.0 | Systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA:22.0 | Systematic Assessment |
| |
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA:22.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA:22.0 | Systematic Assessment |
| |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA:22.0 | Systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA:22.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA:22.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA:22.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA:22.0 | Systematic Assessment |
| |
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA:22.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA:22.0 | Systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA:22.0 | Systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA:22.0 | Systematic Assessment |
| |
| Lymphocyte Count Decreased | Investigations | MedDRA:22.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA:22.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA:22.0 | Systematic Assessment |
| |
| Panic Attack | Psychiatric disorders | MedDRA:22.0 | Systematic Assessment |
| |
| Paranoia | Psychiatric disorders | MedDRA:22.0 | Systematic Assessment |
| |
| Schizophrenia | Psychiatric disorders | MedDRA:22.0 | Systematic Assessment |
| |
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA:22.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA:22.0 | Systematic Assessment |
| |
| Muscle Strain | Injury, poisoning and procedural complications | MedDRA:22.0 | Systematic Assessment |
| |
| Procedural Headache | Injury, poisoning and procedural complications | MedDRA:22.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA:22.0 | Systematic Assessment |
| |
| Pregnancy Of Partner | Social circumstances | MedDRA:22.0 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 13, 2019 | Nov 6, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| C000721087 | TAK-041 |
Not provided
Not provided
Not provided
| Reason not Specified |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Day 14 |
|
|
| 0.0633 |
Bayesian method was used to calculate the posterior probability. High posterior probability of a difference between TAK-041 and placebo >2.0. |
| Superiority |
| OG002 | TAK-041 160 mg | 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. |
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|
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.
| OG002 | TAK-041 160 mg | 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. |
|
|
| OG002 |
| TAK-041 160 mg |
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. |
|
|
| OG002 | TAK-041 160 mg | 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. |
|
|
| TAK-041 40 mg |
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. |
| OG002 | TAK-041 160 mg | 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. |
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