Phase 2
N=366
Clinical Trial of Glatiramer Acetate in Amyotrophic Lateral Sclerosis (ALS)
Amyotrophic Lateral Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT00326625 ↗Enrolled (actual)
366
Serious AEs
29.8%
Results posted
Oct 2021
Primary outcome: Primary: Slope of Change From Baseline in the ALS Functional Rating Scale (ALSFRS-R) — -1.05; -1.00 Units on a Scale per Month — p=0.4807
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 40 mg glatiramer acetate (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Teva Pharmaceutical Industries, Ltd.
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Slope of Change From Baseline in the ALS Functional Rating Scale (ALSFRS-R) |
-1.05; -1.00 | 0.4807 |
| SECONDARY Time to Event: Death, Tracheostomy, Permanent Assisted Ventilation |
NA; NA | 0.8583 |
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).
Eligibility Criteria
Inclusion Criteria
- Diagnosis of definite or probable ALS in accordance with the El-Escorial criteria.
- Subject has experienced his/her first ALS symptoms within 3 years prior to the screening visit.
- Slow VC test equal or greater than 70% of the predicted value.
- The sum of the 3 respiratory items on the ALSFRS-R must total at least 10 points.
- Stable dose of riluzole for at least 8 weeks prior to screening.
- Age - 18-70 (inclusive).
Exclusion Criteria
- The use of invasive or non-invasive ventilation.
- Subject having undergone gastrostomy.
- Subject with any clinically significant or unstable medical condition.
- Subjects participating in any other clinical trial (within 12 weeks prior to screening and thereafter).
- Additional criteria per protocol.
Data sourced from ClinicalTrials.gov (NCT00326625). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.