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

Teva Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Amyotrophic Lateral Sclerosis

Treatments: Drug: Placebo; Drug: 40 mg glatiramer acetate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00326625

ALS-GA-201

Details and patient eligibility

About

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).

Enrollment: 366 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis of definite or probable ALS in accordance with the El-Escorial criteria.
2. Subject has experienced his/her first ALS symptoms within 3 years prior to the screening visit.
3. Slow VC test equal or greater than 70% of the predicted value.
4. The sum of the 3 respiratory items on the ALSFRS-R must total at least 10 points.
5. Stable dose of riluzole for at least 8 weeks prior to screening.
6. Age - 18-70 (inclusive).

Exclusion criteria

1. The use of invasive or non-invasive ventilation.
2. Subject having undergone gastrostomy.
3. Subject with any clinically significant or unstable medical condition.
4. Subjects participating in any other clinical trial (within 12 weeks prior to screening and thereafter).
5. Additional criteria per protocol.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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366 participants in 2 patient groups, including a placebo group

40 mg glatiramer acetate (GA)

Experimental group

Description:

Pre-filled syringe of 40 mg glatiramer acetate (GA) for injection, administered subcutaneously once a day.

Treatment:

Drug: 40 mg glatiramer acetate

Placebo

Placebo Comparator group

Description:

Pre-filled syringe of matching placebo, administered subcutaneously once a day.

Treatment:

Drug: Placebo