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A Long-Term Safety Study of ALKS 5461

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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02141399
Recruitment Status : Completed
First Posted : May 19, 2014
Results First Posted : December 14, 2018
Last Update Posted : December 14, 2018
Sponsor:
Information provided by (Responsible Party):
Alkermes, Inc.

Tracking Information
First Submitted Date  ICMJE May 15, 2014
First Posted Date  ICMJE May 19, 2014
Results First Submitted Date  ICMJE November 21, 2018
Results First Posted Date  ICMJE December 14, 2018
Last Update Posted Date December 14, 2018
Actual Study Start Date  ICMJE May 2014
Actual Primary Completion Date November 20, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 21, 2018)
Incidence of Adverse Events (AEs) [ Time Frame: Up to 56 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 15, 2014)
Safety and tolerability will be assessed by number and percentage of subjects with adverse events (AEs) [ Time Frame: Up to 56 weeks ]
Change History Complete list of historical versions of study NCT02141399 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Long-Term Safety Study of ALKS 5461
Official Title  ICMJE 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)
Brief Summary This is a 52-week open-label study to evaluate the safety and tolerability of ALKS 5461.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE Drug: ALKS 5461
Sublingual tablet, taken daily
Study Arms  ICMJE Experimental: ALKS 5461
Intervention: Drug: ALKS 5461
Publications * Thase M, Stanford AD, Memisoglu A, Martin W, Claxton A, Bodnik JA, Trivedi MH, Fava M, Pathak S. 50 Adjunctive Buprenorphine/Samidorphan Combination in Patients with Major Depressive Disorder: Phase 3 Long-term Extension Study Results. CNS Spectr. 2019 Feb;24(1):203-204. doi: 10.1017/S1092852919000427.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 21, 2018)
1485
Original Estimated Enrollment  ICMJE
 (submitted: May 15, 2014)
1700
Actual Study Completion Date  ICMJE November 20, 2017
Actual Primary Completion Date November 20, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Bulgaria,   Canada,   Germany,   Hungary,   Poland,   Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02141399
Other Study ID Numbers  ICMJE ALK5461-208
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alkermes, Inc.
Study Sponsor  ICMJE Alkermes, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Sanjeev Pathak, MD Alkermes, Inc.
PRS Account Alkermes, Inc.
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP