CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 366 enrolled
Drug / intervention
40 mg glatiramer acetate +1 moredrug
Likely dose
40 mg glatiramer acetatefrom 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/NCT00326625
NCT00326625Phase 2Completed
CompareCT.gov

A Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Tolerability and Safety of 40 mg Glatiramer Acetate Injection in Subjects With Amyotrophic Lateral Sclerosis (ALS)

Teva Pharmaceutical Industries, Ltd.·interventional·Posted May 17, 2006·Updated Aug 3, 2022

In Brief

A Phase 2 clinical trial evaluating 40 mg glatiramer acetate and Placebo for Amyotrophic Lateral Sclerosis. Completed, enrolled 366 participants across 7 sites in 6 countries.

Detailed Summary

Teva is developing 40 mg/ml Glatiramer Acetate (GA) Injection , administered once daily under the skin, for the treatment of ALS. The study drug is a higher dose formulation of Copaxone® (20 mg/ml GA), a marketed medication, approved for the treatment of relapsing-remitting multiple sclerosis. GA is an immunomodulating drug that has anti inflammatory and neuroprotective properties, which are believed to be of therapeutic value in ALS. The study treatment duration is 1 year (52 weeks).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAmyotrophic Lateral Sclerosis
CountriesBelgium, France, Germany, Israel, Italy, United Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 17, 2006
Enrollment StartJul 27, 2006
Primary CompletionJun 17, 2008
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 20.1 years ago

Interventions

40 mg glatiramer acetatedrug

parenteral drug

Placebodrug