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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03610048




Registration number
NCT03610048
Ethics application status
Date submitted
26/07/2018
Date registered
1/08/2018
Date last updated
16/04/2019

Titles & IDs
Public title
A Long Term Study of ALKS 5461 in the Treatment of Refractory Major Depressive Disorder (MDD)
Scientific title
A Phase 3b Extension Study of Adjunctive ALKS 5461 in the Treatment of Refractory Major Depressive Disorder
Secondary ID [1] 0 0
ALK5461-218
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Refractory 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 - Sublingual tablets


Treatment: Drugs: ALKS 5461
samidorphan + buprenorphine administered sublingually

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Subjects with Treatment-emergent Adverse Events (TEAEs) - Number and percentage of subjects experiencing TEAEs
Timepoint [1] 0 0
Up to 68 weeks

Eligibility
Key inclusion criteria
- Completed study ALK5461-217

- Be willing to abide by the contraception requirements as outlined in the study
protocol

- Be willing and able to follow the study procedures and visits as outlined in the
protocol

- Additional criteria may apply
Minimum age
18 Years
Maximum age
72 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Pregnant, planning to become pregnant, or breastfeeding

- A positive urine drug test for drugs of abuse

- Poses a current suicide risk

- Additional criteria may apply

Study design
Purpose of the study
Treatment
Allocation to intervention
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alkermes Investigational Site - Frankston
Recruitment hospital [2] 0 0
Alkermes Investigational Site - Noble Park
Recruitment hospital [3] 0 0
Alkermes Investigational Site - Richmond
Recruitment postcode(s) [1] 0 0
3199 - Frankston
Recruitment postcode(s) [2] 0 0
3174 - Noble Park
Recruitment postcode(s) [3] 0 0
3121 - Richmond
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Oklahoma
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
Tennessee
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Vermont
Country [15] 0 0
United States of America
State/province [15] 0 0
Washington
Country [16] 0 0
Puerto Rico
State/province [16] 0 0
San Juan

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

Ethics approval
Ethics application status

Summary
Brief summary
This study will assess the long-term safety and tolerability of ALKS 5461 as an adjunctive
treatment for refractory MDD.
Trial website
https://clinicaltrials.gov/show/NCT03610048
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Alkermes Medical Director
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
Country 0 0
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/show/NCT03610048