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A Long-Term Safety Study of ALKS 5461

NCT02141399 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1485

Last updated 2018-12-14

Study results available
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Summary

This is a 52-week open-label study to evaluate the safety and tolerability of ALKS 5461.

Conditions

Interventions

DRUG

ALKS 5461

Sublingual tablet, taken daily

Sponsors & Collaborators

  • Alkermes, Inc.

    lead INDUSTRY

Principal Investigators

  • Sanjeev Pathak, MD · Alkermes, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2017-11-20
Completion
2017-11-20

Countries

  • United States
  • Australia
  • Bulgaria
  • Canada
  • Germany
  • Hungary
  • Poland
  • Puerto Rico

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02141399 on ClinicalTrials.gov