Status:
COMPLETED
Clinical Trial of Glatiramer Acetate in Amyotrophic Lateral Sclerosis (ALS)
Lead Sponsor:
Teva Pharmaceutical Industries, Ltd.
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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)...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 27 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 17 2008
Estimated Enrollment :
366 Patients enrolled
Trial Details
Trial ID
NCT00326625
Start Date
July 27 2006
End Date
June 17 2008
Last Update
August 3 2022
Active Locations (7)
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1
Teva Benelux
Haarlem, Belgium
2
Teva Benelux
Leuven, Belgium
3
Teva France
Paris, France
4
Teva Germany
Mörfelden-Walldorf, Germany