CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,057 enrolled
Drug / intervention
ALKS 8700drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02634307
NCT02634307Phase 3Completed

A Phase 3 Open Label Study to Evaluate the Long-term Safety and Tolerability of ALKS 8700 in Adults With Relapsing Remitting Multiple Sclerosis

Biogen·interventional·Posted Dec 18, 2015·Updated Jul 26, 2022

In Brief

A Phase 3 clinical trial evaluating ALKS 8700 for Multiple Sclerosis. Completed, enrolled 1,057 participants across 115 sites in 10 countries.

Detailed Summary

The primary objective of this study is to evaluate the long-term safety and tolerability of ALKS 8700 for the treatment of Relapsing Remitting Multiple Sclerosis (RRMS). The secondary objective of this study is to evaluate treatment effect over time in adult participants with RRMS treated with ALKS 8700.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, Bulgaria, Canada, Germany, Poland, Russia, Serbia, Spain, Ukraine, United States
CollaboratorsAlkermes, Inc.

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 18, 2015
Enrollment StartDec 10, 2015
Primary CompletionJun 1, 2021
Study CompletionNov 11, 2021
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 10.5 years ago

Interventions

ALKS 8700drug

Administered as specified in the treatment arm.