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)
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 366
- Locations
- 6
- Primary Endpoint
- Slope of Change From Baseline in the ALS Functional Rating Scale (ALSFRS-R)
Study Overview
Brief 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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
40 mg glatiramer acetate (GA)
Pre-filled syringe of 40 mg glatiramer acetate (GA) for injection, administered subcutaneously once a day.
Intervention: 40 mg glatiramer acetate (Drug)
Placebo
Pre-filled syringe of matching placebo, administered subcutaneously once a day.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Slope of Change From Baseline in the ALS Functional Rating Scale (ALSFRS-R)
Time Frame: Baseline, Weeks 4, 8, 12, 17, 22, 26, 31, 36, 40, 44, 48, 52
The ALSFRS-R is a questionnaire-based scale for monitoring the progression of disability in patients with ALS. It is composed of 12 items, each scored between 0 and 4.The total score, calculated as the sum of these 12 items, ranges from 0 to 48. The higher the score, the less disabled the participant. Timepoints after baseline were included in calculation of slope of change in ALSFRS-R. Slope is derived from the time by treatment interaction term from the Repeated Measures Analysis of Covariance model. Descriptive statistics of the slope are reported.
Secondary Outcomes
- Time to Event: Death, Tracheostomy, Permanent Assisted Ventilation(Baseline up to 52 weeks)