Back to resultsClinical Trial of Glatiramer Acetate in Amyotrophic Lateral Sclerosis (ALS)
Primary Purpose
Amyotrophic Lateral Sclerosis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
40 mg glatiramer acetate
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Amyotrophic Lateral Sclerosis
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.
Sites / Locations
- Teva Benelux
- Teva Benelux
- Teva France
- Teva Germany
- Teva Germany
- Teva Israel
- Teva Italy
- Teva UK
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
40 mg glatiramer acetate (GA)
Placebo
Arm Description
Pre-filled syringe of 40 mg glatiramer acetate (GA) for injection, administered subcutaneously once a day.
Pre-filled syringe of matching placebo, administered subcutaneously once a day.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT00326625
First Posted
May 16, 2006
Last Updated
August 1, 2022
Sponsor
Teva Pharmaceutical Industries, Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT00326625
Brief Title
Clinical Trial of Glatiramer Acetate in Amyotrophic Lateral Sclerosis (ALS)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
July 27, 2006 (Actual)
Primary Completion Date
June 17, 2008 (Actual)
Study Completion Date
June 17, 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Teva Pharmaceutical Industries, Ltd.
4. Oversight
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
366 (Actual)
8. Arms, Groups, and Interventions
Arm Title
40 mg glatiramer acetate (GA)
Arm Type
Experimental
Arm Description
Pre-filled syringe of 40 mg glatiramer acetate (GA) for injection, administered subcutaneously once a day.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Pre-filled syringe of matching placebo, administered subcutaneously once a day.
Intervention Type
Drug
Intervention Name(s)
40 mg glatiramer acetate
Intervention Description
parenteral drug
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Slope of Change From Baseline in the ALS Functional Rating Scale (ALSFRS-R)
Description
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 Frame
Baseline, Weeks 4, 8, 12, 17, 22, 26, 31, 36, 40, 44, 48, 52
Secondary Outcome Measure Information:
Title
Time to Event: Death, Tracheostomy, Permanent Assisted Ventilation
Description
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.
Time Frame
Baseline up to 52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merav Bassan, PhD.
Organizational Affiliation
Teva Pharmaceuticals Industries LTD
Official's Role
Study Chair
Facility Information:
Facility Name
Teva Benelux
City
Haarlem
Country
Belgium
Facility Name
Teva Benelux
City
Leuven
Country
Belgium
Facility Name
Teva France
City
Paris
Country
France
Facility Name
Teva Germany
City
Moerfelden-Walldorf
Country
Germany
Facility Name
Teva Germany
City
Morfelden-Walldorf
Country
Germany
Facility Name
Teva Israel
City
Tel Aviv
Country
Israel
Facility Name
Teva Italy
City
Milano
Country
Italy
Facility Name
Teva UK
City
Aylesbury
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Clinical Trial of Glatiramer Acetate in Amyotrophic Lateral Sclerosis (ALS)
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