Clinical Trial of Glatiramer Acetate in Amyotrophic Lateral Sclerosis (ALS)

Amyotrophic Lateral Sclerosis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00326625
• Other study ID #: ALS-GA-201
• Status: Completed
• Phase: Phase 2
• Start date: July 27, 2006
• Est. completion date: June 17, 2008

Study information

• Verified date: August 2022
• Source: Teva Branded Pharmaceutical Products R&D, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 366
• Est. completion date: June 17, 2008
• Est. primary completion date: June 17, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

Drug:
• 40 mg glatiramer acetate
parenteral drug
• Placebo

Locations

Country	Name	City	State
Belgium	Teva Benelux	Haarlem
Belgium	Teva Benelux	Leuven
France	Teva France	Paris
Germany	Teva Germany	Moerfelden-Walldorf
Germany	Teva Germany	Morfelden-Walldorf
Israel	Teva Israel	Tel Aviv
Italy	Teva Italy	Milano
United Kingdom	Teva UK	Aylesbury

Sponsors (1)

Lead Sponsor	Collaborator
Teva Pharmaceutical Industries, Ltd.

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Israel,  Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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