Clinical Trial Results:
A 26-week, Multicenter, Open-label, Extension Study of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in Patients with Schizophrenia
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Summary
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EudraCT number |
2012-003806-28 |
Trial protocol |
LV |
Global end of trial date |
17 Feb 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
09 Apr 2016
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First version publication date |
09 Apr 2016
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Other versions |
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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 |
31-12-297
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01683058 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Otsuka Pharmaceutical Development & Commercialization, Inc.
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Sponsor organisation address |
2440 Research Boulevard, Rockville, Maryland, United States, 20850
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Public contact |
Timothy Peters-Strickland, Otsuka Pharmaceutical Development & Commercialization, +1 609-249-6559, Tim.Peters-Strickland@otsuka-us.com
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Scientific contact |
Timothy Peters-Strickland, Otsuka Pharmaceutical Development & Commercialization, +1 609-249-6559, Tim.Peters-Strickland@otsuka-us.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 |
10 May 2014
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
17 Feb 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
17 Feb 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 |
The primary objective of this open-label trial was to evaluate the safety and tolerability of aripiprazole intramuscular (IM) depot administered for 26 weeks to participants with schizophrenia.
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Protection of trial subjects |
The trial was conducted in compliance with the protocol, International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Consolidated Guideline, and the applicable local laws and regulatory requirements of the countries in which the trial was conducted, copies of the protocol, amendments, and informed consent form (ICF) were reviewed and approved by the governing institutional review board (IRB) or independent ethics committee (IEC) for each investigational site or country, as appropriate, prior to trial start or prior to implementation of the amendment at that site or country.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
10 Jan 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 |
Latvia: 1
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Country: Number of subjects enrolled |
United States: 68
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Country: Number of subjects enrolled |
Croatia: 5
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Worldwide total number of subjects |
74
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EEA total number of subjects |
6
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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) |
74
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
A multicenter, open-label, single-arm rollover trial designed to demonstrate the safety of aripiprazole intramuscular (IM) depot [400 or 300 milligrams (mg)] for the acute treatment of participants with schizophrenia, who met completion criteria in the registration trial 2012-003805-86. 74 participants were enrolled in this trial. | ||||||||||||||||||
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Pre-assignment
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Screening details |
Participants entered this trial after completing the Week 12/Early Termination (ET) visit of trial 2012-003805-86 as it served as the Baseline evaluations for this trial. | ||||||||||||||||||
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Period 1
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Period 1 title |
Overall Trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||||
Blinding implementation details |
This was an open-label trial.
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Arms
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Arm title
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Aripiprazole IM Depot 400/300 mg | ||||||||||||||||||
Arm description |
All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for 24 weeks. | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
Aripiprazole
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Investigational medicinal product code |
OPC-14597, Lu AF41155
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Other name |
Abilify
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Pharmaceutical forms |
Powder and suspension for suspension for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
All participants received aripiprazole IM depot 400 mg/ 300 mg every 4 weeks for 24 weeks.
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Baseline characteristics reporting groups
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Reporting group title |
Aripiprazole IM Depot 400/300 mg
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Reporting group description |
All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for 24 weeks. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Aripiprazole IM Depot 400/300 mg
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Reporting group description |
All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for 24 weeks. | ||
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End point title |
Percentage of participants reporting treatment emergent adverse events (TEAEs) [1] | ||||||||||||||||||
End point description |
A TEAE was defined as an AE that began after the first injection or was continuous from Baseline for serious AEs, drug-related AEs and AEs resulting in death were also reported. In safety analysis, all enrolled participants took at least one injection of aripiprazole IM depot 400/300mg in the IM depot treatment period.
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End point type |
Primary
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End point timeframe |
Baseline to Week 24
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analysis was planned for Percentage of participants reporting treatment emergent adverse events (TEAEs), severe TEAEs, discontinued investigational medicinal product (IMP) due to AEs, serious TEAEs and outcome of death |
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Mean change from Baseline in suicidal ideation intensity total score by the Columbia Suicide Severity Rating Scale (C-SSRS) | ||||||||||||||||||||||
End point description |
Data collected from C-SSRS were mapped into C-CASA. The Columbia Classification Algorithm of Suicide Assessment (C-CASA) method and C-SSRS(text in parentheses as said below) were mapped as; 1= completed suicide(completed suicide); 2= suicide attempt(actual attempt); 3= preparatory actions toward imminent suicidal behavior (interrupted attempt, aborted attempt and preparatory acts/behavior); 4= suicidal ideation(wish to die, active suicidal thought, active suicidal thought with method, active suicidal thought with intent, active suicidal thought with plan/intent); 5= self-injurious behavior, intent unknown; 6= not enough information: death; 7= non-suicidal self-injurious behavior(nonsuicidal self-injurious behavior); 8= other accident; psychiatric/medical; 9= not enough information/non-death. C-CASA category 5, 6, 8 and 9 are not applicable. For each item, each participant received an intensity score from 0(none) to 5(worst). Suicidal ideation intensity total score range from 0 to 25.
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End point type |
Secondary
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End point timeframe |
Baseline to Week 24
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| No statistical analyses for this end point | |||||||||||||||||||||||
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End point title |
Mean change from Baseline by Week by Extrapyramidal Symptoms (EPS) evaluated using the Simpson-Angus Scale (SAS) | ||||||||||||
End point description |
The EPS rating scales included SAS total score (range 10-50) was the sum of the rating scores for 10 items from the SAS panel. This scale consists of a list of 10 symptoms, each to be rated on a 5-point scale of severity. For each symptom, the rating which best described the patient's condition were, 1= gait; 2= arm dropping; 3= shoulder shaking; 4= elbow rigidity; 5= wrist rigidity; 6= head rotation; 8= tremor; 9= salivation; 10= akathisia.
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End point type |
Secondary
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End point timeframe |
Baseline to Week 24
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Mean change from Baseline by Week by EPS evaluated using the Abnormal Involuntary Movement Scale (AIMS) | ||||||||||||
End point description |
EPS rating scale included the AIMS movement rating score (range 0-28) was the sum of the rating scores for facial and oral movements (i.e., item 1 - 4), extremity movements (i.e. item 5 - 6), and trunk movements (i.e. item 7). The symptoms for facial and oral movements were 1= muscles of facial expression, 2= lips and perioral area, 3= jaw and 4=tongue; extremity movements were, 5= upper (arms, wrists, hands, fingers), lower (legs, knees, ankles, toes), 7= neck, shoulders, hips). This scale consisted of 10 items, each to be rated on a 4-point scale of severity, and 2 questions to be answered by yes or no. To complete the scale, the patient was observed unobtrusively at rest (e.g., in waiting room). The chair used for this examination was hard, firm one without arms.
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End point type |
Secondary
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End point timeframe |
Baseline to Week 24
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Mean change from Baseline by Week by EPS evaluated using Barnes Akathisia Rating Scale (BARS) | ||||||||||||
End point description |
The BARS global score (range 0-5) was derived from the global clinical assessment of akathisia from the BARS panel were, 0= absent; 1= questionable; 2= mild akathisia; 3= moderate akathisia; 4= marked akathisia; 5= severe akathisia. Participants were observed while they were seated and then standing (for a minimum of 2 minutes in each position). Symptoms were observed in other situations (e.g., while engaged in neutral conversation, engaged in activity on the ward) was also rated.
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End point type |
Secondary
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End point timeframe |
Baseline to Week 24
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Mean change in body temperature from Baseline in all participants. | ||||||||||||||||||||||
End point description |
The body temperature, which is a vital sign parameter was one of the parameters to measure the safety and tolerability of individual participants. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).
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End point type |
Secondary
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End point timeframe |
Baseline to last visit
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| No statistical analyses for this end point | |||||||||||||||||||||||
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End point title |
Mean change in supine heart rate from Baseline in all participants. | ||||||||||||||||||||||
End point description |
The heart rate supine, which is a vital sign parameter was one of the parameters to measure the safety and tolerability of individual participants. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).
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End point type |
Secondary
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End point timeframe |
Baseline to last visit
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| No statistical analyses for this end point | |||||||||||||||||||||||
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End point title |
Mean change in supine systolic blood pressure (BP) from Baseline in all participants. | ||||||||||||||||||||||
End point description |
The systolic supine BP, which is a vital sign parameter was one of the parameters to measure the safety and tolerability of individual participants. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).
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End point type |
Secondary
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End point timeframe |
Baseline to last visit
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| No statistical analyses for this end point | |||||||||||||||||||||||
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End point title |
Mean change in supine diastolic BP from Baseline in all participants. | ||||||||||||||||||||||
End point description |
The diastolic supine BP, which is a vital sign parameter was one of the parameters to measure the safety and tolerability of individual participants. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).
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End point type |
Secondary
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End point timeframe |
Baseline to last visit
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| No statistical analyses for this end point | |||||||||||||||||||||||
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End point title |
Mean change in sitting heart rate from Baseline in all participants. | ||||||||||||||||||||||
End point description |
The heart rate sitting, which is a vital sign parameter was one of the parameters to measure the safety and tolerability of individual participants. Orthostatic assessments of blood pressure and heart rate were made after the participant was supine for at least 5 minutes and again after the participant was sitting for approximately 2 minutes. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).
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End point type |
Secondary
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End point timeframe |
Baseline to last visit
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| No statistical analyses for this end point | |||||||||||||||||||||||
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End point title |
Mean change in sitting systolic BP from Baseline in all participants. | ||||||||||||||||||||||
End point description |
The systolic sitting BP, which is a vital sign parameter was one of the parameters to measure the safety and tolerability of individual participants. Orthostatic assessments of blood pressure and heart rate were made after the participant was supine for at least 5 minutes and again after the participant was sitting for approximately 2 minutes. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).
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End point type |
Secondary
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End point timeframe |
Baseline to last visit
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| No statistical analyses for this end point | |||||||||||||||||||||||
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End point title |
Mean change in sitting diastolic BP from Baseline in all participants. | ||||||||||||||||||||||
End point description |
The diastolic sitting BP, which is a vital sign parameter was one of the parameters to measure the safety and tolerability of individual participants. Orthostatic assessments of blood pressure and heart rate were made after the participant was supine for at least 5 minutes and again after the participant was sitting for approximately 2 minutes. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).
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End point type |
Secondary
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End point timeframe |
Baseline to last visit
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| No statistical analyses for this end point | |||||||||||||||||||||||
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End point title |
Mean change in ventricular rate from Baseline in all participants. | ||||||||||||||
End point description |
The measurement ventricular rate is an ECG parameter which was one of the parameters to measure the safety and tolerability of individual participants. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).
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End point type |
Secondary
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End point timeframe |
Baseline to last visit
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| No statistical analyses for this end point | |||||||||||||||
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End point title |
Mean change in PR interval from Baseline in all participants. | ||||||||||||||
End point description |
The measurement PR interval is an ECG parameter was one of the parameters to measure the safety and tolerability of individual participants. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).
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End point type |
Secondary
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End point timeframe |
Baseline to last visit
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| No statistical analyses for this end point | |||||||||||||||
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End point title |
Mean change in RR interval from Baseline in all participants. | ||||||||||||||
End point description |
The measurement RR interval is an ECG parameter which was one of the primary parameters to measure the safety and tolerability of individual participants. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).
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End point type |
Secondary
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End point timeframe |
Baseline to last visit
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| No statistical analyses for this end point | |||||||||||||||
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End point title |
Mean change in QRS interval from Baseline in all participants. | ||||||||||||||
End point description |
The measurement QRS interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).
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End point type |
Secondary
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End point timeframe |
Baseline to last visit
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| No statistical analyses for this end point | |||||||||||||||
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End point title |
Mean change in QT interval from Baseline in all participants. | ||||||||||||||
End point description |
The measurement QT interval is an ECG parameter which was one of the parameters to measure the safety and tolerability of individual participants. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).
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End point type |
Secondary
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End point timeframe |
Baseline to last visit
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| No statistical analyses for this end point | |||||||||||||||
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End point title |
Mean change in QTcB interval from Baseline in all participants. | ||||||||||||||
End point description |
The measurement QTcB interval is an ECG parameter which was one of the parameters to measure the safety and tolerability of individual participants. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).
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End point type |
Secondary
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End point timeframe |
Baseline to last visit
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| No statistical analyses for this end point | |||||||||||||||
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End point title |
Mean change in QTcF interval from Baseline in all participants. | ||||||||||||||
End point description |
The measurement QTcF interval is an ECG parameter which was one of the parameters to measure the safety and tolerability of individual participants. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).
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End point type |
Secondary
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End point timeframe |
Baseline to last visit
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| No statistical analyses for this end point | |||||||||||||||
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End point title |
Mean change in QTcN interval from Baseline in all participants. | ||||||||||||||
End point description |
The measurement QTcN interval is an ECG parameter which was one of the parameters to measure the safety and tolerability of individual participants. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).
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End point type |
Secondary
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End point timeframe |
Baseline to last visit
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| No statistical analyses for this end point | |||||||||||||||
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End point title |
Mean change in clinically relevant body weight changes from Baseline in all participants. | ||||||||||||||
End point description |
Clinically relevant body weight changes was one of the primary parameters to measure the safety and tolerability of individual participants. Each participant's body mass index (BMI) kilogram per square meter (kg/m2) were calculated from the screening. Body weight, BMI, and waist circumference changes were evaluated by calculating mean change from Baseline and by tabulating the incidence of ≥7% weight gain or loss. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).
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End point type |
Secondary
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End point timeframe |
Baseline to last visit
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| No statistical analyses for this end point | |||||||||||||||
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End point title |
Mean change in clinically relevant body mass index from Baseline in all participants. | ||||||||||||||
End point description |
Clinically relevant body mass index was one of the primary parameters to measure the safety and tolerability of individual participants. Each participant's body mass index (BMI) kilogram per square meter (kg/m2) were calculated from the screening. Body weight, BMI, and waist circumference changes were evaluated by calculating mean change from Baseline and by tabulating the incidence of ≥7% weight gain or loss. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).
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End point type |
Secondary
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End point timeframe |
Baseline to last visit
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| No statistical analyses for this end point | |||||||||||||||
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End point title |
Mean change in clinically relevant waist circumference from Baseline in all participants. | ||||||||||||
End point description |
Clinically relevant waist circumference was one of the primary parameters to measure the safety and tolerability of individual participants. Each participant's body mass index (BMI) kilogram per square meter (kg/m2) were calculated from the screening. Body weight, BMI, and waist circumference changes were evaluated by calculating mean change from Baseline and by tabulating the incidence of ≥7% weight gain or loss. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit). Only Week 24 and last visit data was included. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).
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End point type |
Secondary
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End point timeframe |
Baseline to last visit
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Number of participants with clinically relevant laboratory values. | ||||||||
End point description |
The laboratory values were one of the parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal values in serum chemistry, hematology, urinalyses and prolactin tests that were identified based on pre-defined criteria. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit). There were no clinically relevant findings with regard to laboratory values reported in this study.
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End point type |
Secondary
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End point timeframe |
Baseline to last visit
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| No statistical analyses for this end point | |||||||||
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End point title |
Number of participants with clinically relevant physical examination. | ||||||||
End point description |
The physical examination evaluation was one of the parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in the following body systems: head, ears, eyes, nose, and throat; thorax; abdomen; urogenital; extremities; neurological; and skin and mucosae. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit). None of the abnormalities or findings were noted during physical examination were considered clinically relevant.
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End point type |
Secondary
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End point timeframe |
Baseline to last visit
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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 |
AEs were recorded from the time the ICF was signed until follow-up for safety 14 (±2) days after the last trial visit.
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Adverse event reporting additional description |
A SAE was any untoward medical occurrence that results in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or any new problem, experienced by a participant when enrolled in a trial, whether or not it was considered drug related by the study physician.
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
16.0
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Reporting groups
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Reporting group title |
Aripiprazole IM depot 400/300 mg
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Reporting group description |
All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks. | ||||||||||||||||||||||||||||||||||||||||||||||
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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? Yes | |||
Date |
Amendment |
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27 Sep 2012 |
The changes in this amendment were made to reflect the updates to Protocol 31-12-291 (Trial 2012-003805-86) which eliminated an Interim Analysis. This change required trial 2012-003806-28 remove references to participants who were discontinued from Trial 2012-003805-86 due to a positive interim analysis. General revisions to the protocol were; added Lundbeck Protocol Number Lu AF41155 to cover page and synopsis and made minor formatting corrections. |
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12 Oct 2012 |
The change in this amendment was made to reflect the correction to needle gauge based on Body Mass Index (BMI). General revisions were made to this protocol such as; Deleted all reference to needle: 21 gauge, 1.5 inch for BMI ≤28 kg/m2 participants in the active treatment phase of Trial 2012-003805-86 who were discontinued from that trial due to a positive interim analysis (IA), changed text to needle: 22 gauge, 1.5 inch for BMI ≤28 and minor formatting corrections. |
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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 | |||
