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

NCT00326625 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 366

Last updated 2022-08-03

Study results available
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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

Interventions

DRUG

40 mg glatiramer acetate

parenteral drug

DRUG

Placebo

Sponsors & Collaborators

  • Teva Pharmaceutical Industries, Ltd.

    lead INDUSTRY

Principal Investigators

  • Merav Bassan, PhD. · Teva Pharmaceuticals Industries LTD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-27
Primary Completion
2008-06-17
Completion
2008-06-17

Countries

  • Belgium
  • France
  • Germany
  • Israel
  • Italy
  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00326625 on ClinicalTrials.gov