A multi-national, multi-centre, 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) - n.a.
- Conditions
- Early stage of amyotrophic lateral sclerosis (ALS)MedDRA version: 8.1Level: PTClassification code 10002026
- Registration Number
- EUCTR2006-001688-49-DE
- Lead Sponsor
- TEVA Pharmaceutical Industries. Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
1. Male and female subjects with definite, probable or probable laboratory-supported ALS according to the World Federation of Neurology El Escorial criteria. ALS may be familial or sporadic.
2. Subjects must have experienced their first ALS symptoms within three years prior to the screening visit.
3. Subjects must have a slow VC score equal to or greater than 70% of the predicted value for gender, height and age at the screening and baseline visits.
4. The sum of the three respiratory items from the ALSFRS-R must total at least ten points at the screening and baseline visits.
5. Subjects taking riluzole must be on a stable dose for at least eight weeks prior to the screening visit and their serum AST and ALT levels should not exceed three times the upper normal limit.
6. Subjects must be between 18 and 70 years of age (inclusive).
7. Subjects and caregivers must be willing and able to provide written, informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. The use of invasive or non-invasive ventilation.
2. Subjects having undergone a gastrostomy.
3. Subjects with any clinically significant or unstable medical or surgical condition including cardiovascular, hepatic, pulmonary, renal, autoimmune, endocrine, metabolic or malignancy or any other condition that, in the investigator's opinion, places the subject at undue risk by participating in the study.
4. HBV or HCV seropositive subjects.
5. Subjects having used within the specified time prior to screening any of the following:
+ glatiramer acetate (any previous use)
+ mecasermin (within four weeks prior to screening)
+ rasagiline (within three weeks prior to screening)
+ minocycline (within three weeks prior to screening)
+ a dosage regimen of more than 600 mg/day coenzyme Q10 (within four weeks prior to screening)
+ any other marketed drug not approved for ALS (within twelve weeks prior to screening), excluding symptomatic drugs for ALS and supplements
6. Subjects participating in any other clinical trial for ALS (within twelve weeks prior to screening or thereafter).
7. Women who are pregnant or nursing at the time of screening or intend to be during the study period. Women of child-bearing potential who do not practice medically acceptable methods of contraception.
8. Subjects with current alcohol or drug abuse.
9. Subjects with known sensitivity to mannitol.
10. Subjects without a caregiver or healthcare professional to inject the study medication if unable to do so themselves.
11. Subjects unable at the time of the screening and baseline visits to comply with the planned schedule of study visits and study procedures.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the efficacy, tolerability and safety of once-daily subcutaneous injections of 40 mg glatiramer acetate in subjects with ALS.;Secondary Objective: Time to death / tracheostomy/permanent assisted ventilation;Primary end point(s): Change from baseline to each visit in ALSFRS-R score (slope).
- Secondary Outcome Measures
Name Time Method