CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 194 enrolled
Drug / intervention
Placebo +3 moredrug
Likely dose
Dexpramipexole 50 mg/dayfrom 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/NCT00647296
NCT00647296Phase 2Completed
CompareCT.gov

A 2-Part, Randomized, Double-Blind, Safety and Tolerability Study Evaluating KNS-760704 in Patients With Amyotrophic Lateral Sclerosis (ALS)

Knopp Biosciences·interventional·Posted Mar 31, 2008·Updated Jul 8, 2021

In Brief

A Phase 2 clinical trial evaluating Placebo, Dexpramipexole 50 mg/day, and 2 other interventions for Amyotrophic Lateral Sclerosis. Completed, enrolled 194 participants across 21 sites.

Detailed Summary

This was a 2-part study of dexpramipexole in patients with ALS. Part 1 was a randomized, placebo-controlled, multi-center study to evaluate the safety, tolerability, and clinical effects of oral administration of 3 dosage levels of dexpramipexole vs. placebo for 12 weeks. Part 2 was a randomized, double-blind, 2-arm, parallel group, extension study evaluating the safety, tolerability, and clinical effects of oral administration of 2 dosage levels of dexpramipexole for up to 72 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAmyotrophic Lateral Sclerosis
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 31, 2008
Enrollment StartApr 9, 2008
Primary CompletionJul 31, 2009
Study CompletionSep 4, 2009
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 18.3 years ago

Interventions

Placebodrug

Placebo: 2 tablets taken orally twice daily

Dexpramipexole 50 mg/daydrug

Dexpramipexole: 2 x 12.5 mg tablets taken orally twice daily

Dexpramipexole 150 mg/daydrug

Dexpramipexole: 2 x 37.5 mg tablets taken orally twice daily

Dexpramipexole 300 mg/daydrug

Dexpramipexole: 2 x 75 mg tablets taken orally twice daily