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Completed

NCT Number: NCT00326625

Clinical Trial of Glatiramer Acetate in 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).

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Key information

Conditions

Amyotrophic Lateral Sclerosis Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Teva Benelux, Haarlem, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

40 mg glatiramer acetate

Drug

parenteral drug

Placebo

Drug

Primary outcomes

  1. 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

  1. Time to Event: Death, Tracheostomy, Permanent Assisted Ventilation

    Time frame: Baseline up to 52 weeks

    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.

Sponsors and collaborators

Lead sponsor

Teva Pharmaceutical Industries, Ltd.

Industry

Registry information

Official study title

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)

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
May 17, 2006
Registry last updated
Aug 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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