CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 942 enrolled
Drug / intervention
Dexpramipexole +1 moredrug
Likely dose
Dexpramipexole 150mgfrom 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/NCT01281189
NCT01281189Phase 3Completed

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Safety and Efficacy of Dexpramipexole in Subjects With Amyotrophic Lateral Sclerosis

Knopp Biosciences·interventional·Posted Jan 21, 2011·Updated Jun 7, 2021

In Brief

A Phase 3 clinical trial evaluating Dexpramipexole and Placebo for Amyotrophic Lateral Sclerosis. Completed, enrolled 942 participants across 82 sites in 11 countries.

Detailed Summary

The purpose of this study is to determine whether dexpramipexole (150 mg twice daily) is safe and effective in the treatment of Amyotrophic Lateral Sclerosis (ALS).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Belgium, Canada, France, Germany, Ireland, Netherlands, Spain, Sweden, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 21, 2011
Enrollment StartMar 1, 2011
Primary CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 15.4 years ago

Interventions

Dexpramipexoledrug

Oral tablet 150mg twice daily for up to 18 months.

Placebodrug

Oral tablet twice daily for up to 18 months.