Clinical Trial Results:
Interventional, open-label, long-term extension study to evaluate the safety and tolerability of brexpiprazole as adjunctive treatment in patients with major depressive disorder.
THE STUDY WAS PREMATURELY TERMINATED AND NO FIRM CONCLUSIONS CAN BE DRAWN REGARDING SAFETY AND EFFICACY
Summary
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EudraCT number |
2012-004169-42 |
Trial protocol |
SE LT DE GB IT FI SK PL BG LV EE |
Global end of trial date |
13 May 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
06 Jul 2016
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First version publication date |
22 Jul 2015
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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 |
000014767B
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01944969 | ||
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 |
LundbeckClinicalTrials@lundbeck.com, H. Lundbeck A/S, +45 36301311, LundbeckClinicalTrials@lundbeck.com
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Scientific contact |
LundbeckClinicalTrials@lundbeck.com, H. Lundbeck A/S, +45 36301311, 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 |
13 May 2014
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
13 May 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
13 May 2014
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
To evaluate the long-term safety and tolerability of brexpiprazole as adjunct treatment to antidepressant (ADT)
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Protection of trial subjects |
Safety data were reviewed regularly by the Lundbeck brexpiprazole Safety Committee to ensure that prompt action was taken, if needed, to maximise patient safety.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
08 Oct 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 |
Slovakia: 2
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Country: Number of subjects enrolled |
Sweden: 2
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Country: Number of subjects enrolled |
United Kingdom: 1
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Country: Number of subjects enrolled |
Estonia: 3
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Country: Number of subjects enrolled |
Finland: 2
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Country: Number of subjects enrolled |
Germany: 2
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Country: Number of subjects enrolled |
United States: 14
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Worldwide total number of subjects |
26
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EEA total number of subjects |
12
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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) |
3
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From 65 to 84 years |
23
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85 years and over |
0
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Recruitment
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Recruitment details |
Patients who had completed a randomised, double-blind study with adjunctive brexpiprazole treatment of MDD (lead-in studies 14570A or 14571A) were eligible to enter this extension study. | ||||||||||||||||
Pre-assignment
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Screening details |
Patients who had completed a randomised, double-blind study with adjunctive brexpiprazole treatment of MDD (lead-in studies 14570A or 14571A) were eligible to enter this extension study. | ||||||||||||||||
Period 1
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Period 1 title |
Baseline (week 0-4)
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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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Are arms mutually exclusive |
Yes
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Arm title
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Adult (lead in from study 14570A) | ||||||||||||||||
Arm description |
Baseline visit in this study was the same as completion visit in the lead in study 14570A (adults). | ||||||||||||||||
Arm type |
Experimental | ||||||||||||||||
Investigational medicinal product name |
Brexpiprazole
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Investigational medicinal product code |
Lu AF41156
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Other name |
OPC-34712
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
The patients received brexpiprazole 1 mg/day for the first week, and during the next 3 weeks were up-titrated in weekly steps to maximally 3 mg/day. In addition they received the same ADT as used in the lead in study.
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Arm title
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Elderly (lead in from study 14571A) | ||||||||||||||||
Arm description |
Baseline visit was the same as the completion visit in the lead in study 14571A (elderly). | ||||||||||||||||
Arm type |
Experimental | ||||||||||||||||
Investigational medicinal product name |
Brexpiprazole
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Investigational medicinal product code |
Lu AF41156
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Other name |
OPC-34712
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
The patients received brexpiprazole 0.5 mg/day for the first week, and during the next 3 weeks were up-titrated in weekly steps to maximally 3 mg/day. In addition they received the same ADT as used in the lead in study.
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Period 2
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Period 2 title |
Mainteance treatment (week 4 onwards)
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Is this the baseline period? |
No | ||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||
Arms
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Arm title
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Total | ||||||||||||||||
Arm description |
Up to 3 mg brexpiprazole per day plus continuation of adjunctive treatment to antidepressant treatment (ADT) received in lead in study | ||||||||||||||||
Arm type |
Experimental | ||||||||||||||||
Investigational medicinal product name |
Brexpiprazole
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Investigational medicinal product code |
Lu AF41156
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Other name |
OPC-34712
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
The dose of brexpiprazole could be increased or decreased during the study within the range of 1 to 3 mg/day. The dose of ADT should remain stable as much as possible, but could be changed from Week 14 onwards, if considered necessary by the investigator. Treatment with brexpiprazole was to be continued up to 52 weeks. However, the study was prematirely terminated.
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Baseline characteristics reporting groups
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Reporting group title |
Adult (lead in from study 14570A)
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Reporting group description |
Baseline visit in this study was the same as completion visit in the lead in study 14570A (adults). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Elderly (lead in from study 14571A)
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Reporting group description |
Baseline visit was the same as the completion visit in the lead in study 14571A (elderly). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Adult (lead in from study 14570A)
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Reporting group description |
Baseline visit in this study was the same as completion visit in the lead in study 14570A (adults). | ||
Reporting group title |
Elderly (lead in from study 14571A)
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Reporting group description |
Baseline visit was the same as the completion visit in the lead in study 14571A (elderly). | ||
Reporting group title |
Total
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Reporting group description |
Up to 3 mg brexpiprazole per day plus continuation of adjunctive treatment to antidepressant treatment (ADT) received in lead in study |
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End point title |
Total number of treatment-emergent adverse events [1] | ||||||||||||
End point description |
Please see Adverse events section for full adverse event report
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End point type |
Primary
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End point timeframe |
baseline to end of study (prematurely terminated)
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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 comparison between parameters were performed. Only number of adverse event are reported |
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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 |
Total
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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? Yes | |||||||
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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. | |||||||
Early termination leading to a small number analysed; only AEs reported |