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)

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 Overview

• Status: Completed
• Conditions: Amyotrophic Lateral Sclerosis
• Intervention / Treatment: Drug: Placebo; Drug: 40 mg glatiramer acetate

• Study Type: Interventional
• Enrollment (Actual): 366
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Haarlem, Belgium
    • Teva Benelux
  • Leuven, Belgium
    • Teva Benelux
• France
  • Paris, France
    • Teva France
• Germany
  • Moerfelden-Walldorf, Germany
    • Teva Germany
  • Morfelden-Walldorf, Germany
    • Teva Germany
• Israel
  • Tel Aviv, Israel
    • Teva Israel
• Italy
  • Milano, Italy
    • Teva Italy
• United Kingdom
  • Aylesbury, United Kingdom
    • Teva UK

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 40 mg glatiramer acetate (GA); Pre-filled syringe of 40 mg glatiramer acetate (GA) for injection, administered subcutaneously once a day.	Drug: 40 mg glatiramer acetate; parenteral drug
Placebo Comparator: Placebo; Pre-filled syringe of matching placebo, administered subcutaneously once a day.	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Slope of Change From Baseline in the ALS Functional Rating Scale (ALSFRS-R)	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.	Baseline, Weeks 4, 8, 12, 17, 22, 26, 31, 36, 40, 44, 48, 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Event: Death, Tracheostomy, Permanent Assisted Ventilation	Composite endpoint of time to death, tracheostomy, or permanent assisted ventilation analyzed using the Cox's proportional hazards model to compare the risk of death, tracheostomy, or permanent assisted ventilation between treatment groups. The model includes center country, Riluzole© use, site of ALS onset, time from ALS onset, and baseline ALSFRS-R score, baseline slow VC and baseline BMI as covariates. Because less than 50% of participants experienced the event, the median time to event (i.e. the descriptive statistic for the day for which 50% of participants experienced the event) could not be calculated. Hence the days are reported as not available.	Baseline up to 52 weeks

Collaborators and Investigators

• Sponsor: Teva Pharmaceutical Industries, Ltd.
• Investigators: Study Chair: Merav Bassan, PhD., Teva Pharmaceuticals Industries LTD

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2006
• Primary Completion (Actual): June 17, 2008
• Study Completion (Actual): June 17, 2008

Study Registration Dates

• First Submitted: May 16, 2006
• First Submitted That Met QC Criteria: May 16, 2006
• First Posted (Estimate): May 17, 2006

Study Record Updates

• Last Update Posted (Actual): August 3, 2022
• Last Update Submitted That Met QC Criteria: August 1, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Diseases; Neurodegenerative Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Sclerosis; Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Physiological Effects of Drugs; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Adjuvants, Immunologic; Glatiramer Acetate; (T,G)-A-L
• Other Study ID Numbers: ALS-GA-201