Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03610048




Registration number
NCT03610048
Ethics application status
Date submitted
26/07/2018
Date registered
1/08/2018
Date last updated
16/07/2021

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)
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
Sex
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
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
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/08/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2020
Sample size
Target
Accrual to date
Final
175
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/ct2/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/ct2/show/NCT03610048