NCT00326625

Clinical Trial of Glatiramer Acetate in Amyotrophic Lateral Sclerosis (ALS)

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 366 (actual)
• Sponsor: Teva Pharmaceutical Industries, Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Amyotrophic Lateral Sclerosis

Interventions

Type	Name	Description
DRUG	40 mg glatiramer acetate	parenteral drug
DRUG	Placebo

Timeline

• Start date: 2006-07-27
• Primary completion: 2008-06-17
• Completion: 2008-06-17
• First posted: 2006-05-17
• Last updated: 2022-08-03
• Results posted: 2021-10-20

Locations

7 sites across 6 countries: Belgium, France, Germany, Israel, Italy, United Kingdom