Clinical Trial Results:
A Phase 3, Multicenter Study to Assess the Long Term Safety and Tolerability of ALKS 3831 in Subjects with Schizophrenia
Summary
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EudraCT number |
2015-003880-13 |
Trial protocol |
SK HU BG |
Global end of trial date |
18 Jun 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
04 Jul 2019
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First version publication date |
04 Jul 2019
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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 |
ALK3831-A306
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02669758 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Alkermes
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Sponsor organisation address |
852 Winter Street, Waltham, United States, 02451
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Public contact |
Eva Stroynowski, Alkermes Inc, ++1 718609-7000, eva.stroynowski@alkermes.com
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Scientific contact |
Eva Stroynowski, Alkermes Inc, ++1 718609-7000, eva.stroynowski@alkermes.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 |
12 Feb 2019
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
18 Jun 2018
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Global end of trial reached? |
Yes
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Global end of trial date |
18 Jun 2018
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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 study is to evaluate the long term safety and tolerability of ALKS 3831 in subjects with schizophrenia.
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Protection of trial subjects |
This trial was conducted in compliance with Good Clinical Practice (GCP) guidelines for conducting clinical trials. The informed consent form (ICF), protocol, and amendments were reviewed and approved by the institutional review board (IRB) or independent ethics committee (IEC) for each clinical trial site.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Jan 2016
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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 |
Bulgaria: 100
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Country: Number of subjects enrolled |
United States: 75
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Country: Number of subjects enrolled |
Ukraine: 69
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Country: Number of subjects enrolled |
Serbia: 33
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Worldwide total number of subjects |
277
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EEA total number of subjects |
100
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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) |
273
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From 65 to 84 years |
4
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85 years and over |
0
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Recruitment
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Recruitment details |
Subjects who completed the 4-week treatment period of the antecedent study, ALK3831-A305, were eligible to be enrolled in Study ALK3831-A306 within 7 days of their last study visit in ALK3831-A305. | ||||||||||||||||||||||||
Pre-assignment
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Screening details |
A total of 4 subjects enrolled but were not dosed. Three subjects were lost-to-follow-up prior to receiving study drug, and one subject was not compliant with study drug. A total of 277 patients were administered at least one dose of ALKS 3831 and were included in the safety population. | ||||||||||||||||||||||||
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 |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||||||||||
Arms
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Arm title
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ALKS 3831 | ||||||||||||||||||||||||
Arm description |
Olanzapine + samidorphan; administered as a coated bilayer tablet | ||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||
Investigational medicinal product name |
ALKS 3831
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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 |
Tablets were administered for daily dosing
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Baseline characteristics reporting groups
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Reporting group title |
Overall Study
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Safety Population
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Subject analysis set type |
Safety analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
The Safety Population includes all subjects who received at least one dose of study drug.
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End points reporting groups
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Reporting group title |
ALKS 3831
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Reporting group description |
Olanzapine + samidorphan; administered as a coated bilayer tablet | ||
Subject analysis set title |
Safety Population
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
The Safety Population includes all subjects who received at least one dose of study drug.
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End point title |
Incidence of Adverse Events [1] | ||||||
End point description |
Safety population includes all subjects who received at least one dose of study drug.
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End point type |
Primary
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End point timeframe |
Up to 52 weeks
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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: Summary statistics were conducted for the primary endpoint, and have been included. |
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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 |
Up to 52 weeks
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
19.0
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Reporting groups
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Reporting group title |
ALKS 3831
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Reporting group description |
Administered as a coated bilayer tablet; ALKS 3831: Daily dosing | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 2% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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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28 Mar 2016 |
Updated laboratory parameters, and added clarification lanauge |
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25 Apr 2017 |
Clarification language added surrounding end of study visits; dosage and administration details were updated. |
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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 |