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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03610048
Other study ID # ALK5461-218
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
Start date August 9, 2018
Est. completion date May 1, 2020

Study information

Verified date June 2021
Source Alkermes, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will assess the long-term safety and tolerability of ALKS 5461 as an adjunctive treatment for refractory MDD.


Recruitment information / eligibility

Status Terminated
Enrollment 175
Est. completion date May 1, 2020
Est. primary completion date May 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 72 Years
Eligibility 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 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


Related Conditions & MeSH terms


Intervention

Drug:
ALKS 5461
samidorphan + buprenorphine administered sublingually

Locations

Country Name City State
Australia Alkermes Investigational Site Frankston Victoria
Australia Alkermes Investigational Site Noble Park Victoria
Australia Alkermes Investigational Site Richmond Victoria
Puerto Rico Alkermes Investigational Site San Juan
Puerto Rico Alkermes Investigational Site San Juan
United States Alkermes Investigational Site Allentown Pennsylvania
United States Alkermes Investigational Site Atlanta Georgia
United States Alkermes Investigational Site Bellevue Washington
United States Alkermes Investigational Site Canton Ohio
United States Alkermes Investigational Site Cincinnati Ohio
United States Alkermes Investigational Site Dallas Texas
United States Alkermes Investigational Site Decatur Georgia
United States Alkermes Investigational Site DeSoto Texas
United States Alkermes Investigational Site Hollywood Florida
United States Alkermes Investigational Site Jacksonville Florida
United States Alkermes Investigational Site Jamaica New York
United States Alkermes Investigational Site Lauderhill Florida
United States Alkermes Investigational Site Little Rock Arkansas
United States Alkermes Investigational Site Los Alamitos California
United States Alkermes Investigational Site Memphis Tennessee
United States Alkermes Investigational Site Mount Kisco New York
United States Alkermes Investigational Site O'Fallon Missouri
United States Alkermes Investigational Site Oceanside California
United States Alkermes Investigational Site Oklahoma City Oklahoma
United States Alkermes Investigational Site Orlando Florida
United States Alkermes Investigational Site Palm Bay Florida
United States Alkermes Investigational Site Pico Rivera California
United States Alkermes Investigational Site Pikesville Maryland
United States Alkermes Investigational Site Redlands California
United States Alkermes Investigational Site Santa Ana California
United States Alkermes Investigational Site Sherman Oaks California
United States Alkermes Investigational Site Temecula California
United States Alkermes Investigational Site Tucson Arizona
United States Alkermes Investigational Site Woodstock Vermont

Sponsors (1)

Lead Sponsor Collaborator
Alkermes, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Puerto Rico, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Subjects With Treatment-emergent Adverse Events (TEAEs) Number and percentage of subjects experiencing TEAEs Up to 68 weeks