Clinical Trial of Glatiramer Acetate in Amyotrophic Lateral Sclerosis (ALS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00326625|
Recruitment Status : Completed
First Posted : May 17, 2006
Results First Posted : October 20, 2021
Last Update Posted : October 20, 2021
|Condition or disease||Intervention/treatment||Phase|
|Amyotrophic Lateral Sclerosis||Drug: 40 mg glatiramer acetate Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||366 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official 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)|
|Actual Study Start Date :||July 27, 2006|
|Actual Primary Completion Date :||June 17, 2008|
|Actual Study Completion Date :||June 17, 2008|
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
Placebo Comparator: Placebo
Pre-filled syringe of matching placebo, administered subcutaneously once a day.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00326625
|Tel Aviv, Israel|
|Aylesbury, United Kingdom|
|Study Chair:||Merav Bassan, PhD.||Teva Pharmaceuticals Industries LTD|