Clinical Trial Results:
Interventional, Randomised, Double-blind, Parallel-group, Placebo-controlled, Active-reference, Flexible-dose Study of Brexpiprazole in Patients With Acute Schizophrenia
Summary
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EudraCT number |
2012-002252-17 |
Trial protocol |
CZ DE EE SK PL RO |
Global end of trial date |
17 Dec 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
14 Jul 2016
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First version publication date |
14 Jul 2016
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
14644A
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01810380 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
H. Lundbeck A/S
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Sponsor organisation address |
Ottiliavej 9, Valby, Denmark, 2500
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Public contact |
Email contact via, H. Lundbeck A/S, LundbeckClinicalTrials@Lundbeck.com
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Scientific contact |
Email contact via, H. Lundbeck A/S, LundbeckClinicalTrials@Lundbeck.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
17 Dec 2014
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
17 Dec 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
17 Dec 2014
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To determine the efficacy and safety of brexpiprazole for the treatment of adults experiencing an acute episode of schizophrenia
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Protection of trial subjects |
The trial was conducted in accordance with the Declaration of Helsinki (2008) and ICH Good Clinical
Practice (1996)
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
25 Mar 2013
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Estonia: 11
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Country: Number of subjects enrolled |
France: 2
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Country: Number of subjects enrolled |
Poland: 15
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Country: Number of subjects enrolled |
Romania: 38
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Country: Number of subjects enrolled |
Russian Federation: 116
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Country: Number of subjects enrolled |
Serbia: 35
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Country: Number of subjects enrolled |
Slovakia: 3
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Country: Number of subjects enrolled |
Ukraine: 88
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Country: Number of subjects enrolled |
United States: 160
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Worldwide total number of subjects |
468
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EEA total number of subjects |
69
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
466
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From 65 to 84 years |
2
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||||||||||||||||||||||||||||||||||
Pre-assignment
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Screening details |
Subjects who met each of the inclusion and none of the exclusion criteria were eligible to participate in the study | ||||||||||||||||||||||||||||||||||||||||||||
Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||||||||||||||||||||||||||||
Roles blinded |
Subject, Investigator | ||||||||||||||||||||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Placebo | ||||||||||||||||||||||||||||||||||||||||||||
Arm description |
- | ||||||||||||||||||||||||||||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Once daily as tablets and capsules, orally
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Arm title
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Brexpiprazole | ||||||||||||||||||||||||||||||||||||||||||||
Arm description |
- | ||||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Brexpiprazole
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
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Arm title
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Quetiapine extended release | ||||||||||||||||||||||||||||||||||||||||||||
Arm description |
- | ||||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Quetiapine Extended Release
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally
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Baseline characteristics reporting groups
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Reporting group title |
Placebo
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Brexpiprazole
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Quetiapine extended release
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Placebo
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Reporting group description |
- | ||
Reporting group title |
Brexpiprazole
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Reporting group description |
- | ||
Reporting group title |
Quetiapine extended release
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Reporting group description |
- |
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End point title |
Change from baseline to Week 6 in PANSS total score | ||||||||||||||||
End point description |
The Positive and Negative Syndrome Scale (PANSS) is a 30-item scale for assessing the symptoms of schizophrenia. For each PANSS item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score (30 items) ranged from 30 to 210 with a higher score indicating greater severity of symptoms.
Population Description: Full Analysis Set (FAS)
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End point type |
Primary
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End point timeframe |
Baseline and Week 6
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Statistical analysis title |
Placebo vs. Brexpiprazole | ||||||||||||||||
Statistical analysis description |
The overall significance level was 0.05. The primary and the key secondary endpoints were tested hierarchically. Only if the primary endpoint was statistically significant would confirmatory testing continue with the key secondary endpoint.
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Comparison groups |
Placebo v Brexpiprazole
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Number of subjects included in analysis |
309
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Analysis specification |
Pre-specified
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Analysis type |
other | ||||||||||||||||
P-value |
= 0.056 [1] | ||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||
Parameter type |
Least square mean difference | ||||||||||||||||
Point estimate |
-4.1
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Confidence interval |
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level |
95% | ||||||||||||||||
sides |
2-sided
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lower limit |
-8.2 | ||||||||||||||||
upper limit |
0.1 | ||||||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
2.1
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Notes [1] - For all efficacy analyses the primary comparison is the difference between brexpiprazole 2 to 4 mg/day and placebo at Week 6. |
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Statistical analysis title |
Placebo vs. Quetiapine Extended Release | ||||||||||||||||
Comparison groups |
Placebo v Quetiapine extended release
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Number of subjects included in analysis |
309
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Analysis specification |
Pre-specified
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Analysis type |
other | ||||||||||||||||
P-value |
= 0.0002 | ||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||
Parameter type |
Least square mean difference | ||||||||||||||||
Point estimate |
-8
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Confidence interval |
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level |
95% | ||||||||||||||||
sides |
2-sided
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lower limit |
-12.2 | ||||||||||||||||
upper limit |
-3.9 | ||||||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
2.1
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End point title |
Change from baseline to Week 6 in CGI-S score | ||||||||||||||||
End point description |
The Clinical Global Impression – Severity of Illness (CGI-S) provides the clinician’s impression of the patient’s current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients).
Population Description: FAS
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End point type |
Secondary
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End point timeframe |
Baseline and Week 6
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No statistical analyses for this end point |
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End point title |
CGI-I score at Week 6 | ||||||||||||||||
End point description |
The Clinical Global Impression – Global Improvement (CGI-I) provides the clinician’s impression of the patient’s improvement (or worsening). The clinician assesses the patient’s condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). In all cases, the assessment should be made independent of whether the rater believes the improvement is drug-related or not.
Population Description: FAS
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End point type |
Secondary
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End point timeframe |
Week 6
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No statistical analyses for this end point |
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End point title |
Change from baseline to Week 6 in PANSS Positive Subscale score | ||||||||||||||||
End point description |
The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Positive Subscale score is calculated from 7 items (for example: delusions, conceptual disorganization and hallucinatory behaviour). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms
Population Description: FAS
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End point type |
Secondary
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End point timeframe |
Baseline and Week 6
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No statistical analyses for this end point |
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End point title |
Change from baseline to Week 6 in PANSS Negative Subscale score | ||||||||||||||||
End point description |
The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Negative Subscale score is calculated from 7 items (for example: blunted affect, emotional withdrawal and poor rapport). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms
Population Description: FAS
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End point type |
Secondary
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End point timeframe |
Baseline and Week 6
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No statistical analyses for this end point |
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End point title |
Change from baseline to Week 6 in PANSS General Psychopathology Subscale score | ||||||||||||||||
End point description |
The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS General Psychopathology Subscale score is calculated from 16 items (for example: somatic concern, anxiety and guilt feelings). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms
Population Description: FAS
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End point type |
Secondary
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End point timeframe |
Baseline and Week 6
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No statistical analyses for this end point |
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End point title |
Change from baseline to Week 6 in PANSS Excited Component score | ||||||||||||||||
End point description |
The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Excited Component score is calculated from 5 items (for example: poor impulse control, tension and hostility). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms
Population Description: FAS
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End point type |
Secondary
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End point timeframe |
Baseline and Week 6
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No statistical analyses for this end point |
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End point title |
Change from baseline to Week 6 in PANSS Marder Factor scores: negative symptoms | ||||||||||||||||
End point description |
The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Marder Factor scores: negative symptoms is calculated from 7 items (for example: blunted affect, emotional withdrawal and motor retardation). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms
Population Description: FAS
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End point type |
Secondary
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End point timeframe |
Baseline and Week 6
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No statistical analyses for this end point |
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End point title |
Change from baseline to Week 6 in PANSS Marder Factor scores: positive symptoms | ||||||||||||||||
End point description |
The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Marder Factor scores: positive symptoms is calculated from 8 items (for example: delusions, conceptual disorganization and stereotype thinking). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms
Population Description: FAS
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End point type |
Secondary
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End point timeframe |
Baseline and Week 6
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No statistical analyses for this end point |
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End point title |
Change from baseline to Week 6 in PANSS Marder Factor scores: disorganized thoughts | ||||||||||||||||
End point description |
The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Marder Factor scores: disorganized thoughts is calculated from 7 items (for example: conceptual disorganization, difficulty in abstract thinking and mannerisms and posturing). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms
Population Description: FAS
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End point type |
Secondary
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End point timeframe |
Baseline and Week 6
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No statistical analyses for this end point |
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End point title |
Change from baseline to Week 6 in PANSS Marder Factor scores: uncontrolled hostility/excitement | ||||||||||||||||
End point description |
The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Marder Factor scores: uncontrolled hostility/excitement is calculated from 4 items (for example: excitement, hostility, and uncooperativeness).Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms
Population Description: FAS
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End point type |
Secondary
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End point timeframe |
Baseline and Week 6
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No statistical analyses for this end point |
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End point title |
Change from baseline to Week 6 in PANSS Marder Factor scores: anxiety/depression | ||||||||||||||||
End point description |
The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Marder Factor scores: anxiety/depression is calculated from 4 items (for example: anxiety, guilt feelings, and tension). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms
Population Description: FAS
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End point type |
Secondary
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End point timeframe |
Baseline and Week 6
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No statistical analyses for this end point |
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End point title |
Discontinuation due to lack of efficacy during the study | ||||||||||||||||
End point description |
Discontinuation due to lack of efficacy was based on the primary reason for withdrawal, based on all patients treated set (APTS)
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End point type |
Secondary
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End point timeframe |
Baseline to Week 6
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No statistical analyses for this end point |
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End point title |
Response rate at Week 6 | ||||||||||||||||
End point description |
The response rate was defined as a reduction of ≥30% from baseline in PANSS total score OR a CGI-I score of 1 or 2
Population Description: FAS (last assessment)
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End point type |
Secondary
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End point timeframe |
Baseline and Week 6
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No statistical analyses for this end point |
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End point title |
Change from baseline to Week 6 in PSP total score | ||||||||||||||||
End point description |
The Personal and Social Performance Scale (PSP) is a clinician-rated scale designed and validated to measure a patient’s current level of social functioning. The PSP scale consists of a 100-point single-item rating scale, subdivided into 10 equal intervals. Scores of 1 to 10 indicate lack of autonomy in basic functioning, whereas scores of 91 to 100 reflect excellent functioning. The total score is and is based on 4 primary domains of PSP (socially useful activities (including work and study), personal and social relationships, self-care, and disturbing and aggressive behaviours). The 4 domains are assessed on a 6-point scale, from absent to very severe. A higher score indicates a better performance.
Population Description: only patients with PSP assessments between Days 15 to 27 and after Day 35 were included in this analysis; the number of participants analysed is therefore smaller than the defined FAS and also smaller than other PSP analyses using LOCF
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End point type |
Secondary
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End point timeframe |
Baseline and Week 6
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No statistical analyses for this end point |
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End point title |
PSP functional remission rate at Week 6 | ||||||||||||||||
End point description |
The PSP functional remission rate was defined as a PSP total score ≥71
FAS (last assessment). Patients who have no post-baseline PSP values available were not included as response is defined based on change from baseline and no baseline carried forward analysis was planned; the number of participants analyzed is therefore smaller than the defined FAS.
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End point type |
Secondary
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End point timeframe |
Week 6
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No statistical analyses for this end point |
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End point title |
PSP functional response rate at Week 6 | ||||||||||||||||
End point description |
The PSP functional response rate was defined as ≥10 point improvement from Baseline on the PSP total score
Population Description : Patients who have no post-baseline PSP values available were not included as response is defined based on change from baseline and no baseline carried forward analysis was planned; the number of participants analyzed is therefore smaller than the defined FAS.
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End point type |
Secondary
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End point timeframe |
Week 6
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No statistical analyses for this end point |
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End point title |
PSP domain D: disturbing and aggressive behaviours at Week 6 | ||||||||||||||||
End point description |
PSP domain D: disturbing and aggressive behaviours were categorised as “aggressive” (corresponding to mild, manifest, marked, severe, or very severe) or “nonaggressive” (corresponding to absent)
Population Description: only patients who have PSP assessment at Week 6 were included in this analysis; the number of participants analysed is therefore smaller than the defined FAS and also smaller than other PSP analyses where last assessment carried forward was used
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End point type |
Secondary
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End point timeframe |
Week 6
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
First dose to follow-up
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
16.1
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Reporting groups
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Reporting group title |
Placebo
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Quetiapine Extended Release
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Brexpiprazole
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |