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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02141399




Registration number
NCT02141399
Ethics application status
Date submitted
15/05/2014
Date registered
19/05/2014
Date last updated
14/12/2018

Titles & IDs
Public title
A Long-Term Safety Study of ALKS 5461
Scientific title
A Phase 3 Multicenter Study of the Long-Term Safety and Tolerability of ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder in Adults Who Have an Inadequate Response to Antidepressant Therapy (the FORWARD-2 Study)
Secondary ID [1] 0 0
ALK5461-208
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Depressive Disorder 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ALKS 5461

Experimental: ALKS 5461 -


Treatment: Drugs: ALKS 5461
Sublingual tablet, taken daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Adverse Events (AEs)
Timepoint [1] 0 0
Up to 56 weeks

Eligibility
Key inclusion criteria
- Agree to use an approved method of contraception for the duration of the study

- Have the potential to safely benefit from the administration of ALKS 5461

- Have a diagnosis of major depressive disorder (MDD)

- Additional criteria may apply
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Have a positive test for drugs of abuse

- Currently pregnant or breastfeeding

- Have a current primary Axis-I disorder other than MDD

- Have used opioid agonists (eg, codeine, oxycodone, tramadol, morphine) or opioid
antagonists (eg, naloxone, naltrexone) within 14 days

- Have received electroconvulsive therapy treatment within the last 2 years, or received
more than 1 course of electroconvulsive treatment during their lifetime

- Have attempted suicide within the past 2 years

- Have a history of intolerance, allergy, or hypersensitivity to buprenorphine or opioid
antagonists (eg, naltrexone, naloxone)

- Have had a significant blood loss or blood donation within the past 60 days

- Additional criteria may apply

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/11/2017
Sample size
Target
Accrual to date
Final
1485
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Alkermes Investigational Site - Towong
Recruitment hospital [2] 0 0
Alkermes Investigational Site - Frankston
Recruitment hospital [3] 0 0
Alkermes Investigational Site - Melbourne
Recruitment postcode(s) [1] 0 0
4066 - Towong
Recruitment postcode(s) [2] 0 0
3199 - Frankston
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment outside Australia
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Alabama
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Arizona
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Washington
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Wisconsin
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Bulgaria
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Bourgas
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Bulgaria
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Kazanlak
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Sofia
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Varna
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Veliko Turnovo
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Vratza
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British Columbia
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Achim
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Ellwangen
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Stralsund
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Gdansk
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Gorlice
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San Juan

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Alkermes, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a 52-week open-label study to evaluate the safety and tolerability of ALKS 5461.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02141399
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sanjeev Pathak, MD
Address 0 0
Alkermes, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
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Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02141399