NL-OMON44970
Completed
Phase 3
A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 2/3 study to compare the efficacy and safety of masitinib versus placebo in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - AB10015
AB Science0 sites10 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- ALS
- Sponsor
- AB Science
- Enrollment
- 10
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial is onging in other countries
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Female or male patient aged between 18 and 75 years of age, with a
- •weight \> 50 kg and BMI between 18 and 35 kg/m².
- •2\. Familial or sporadic ALS
- •3\. Patient diagnosed with laboratory supported, clinically probable or
- •definite ALS according to the World Federation of Neurology Revised El
- •Escorial criteria (Brooks, 1994\)
- •4\. Disease duration from symptoms onset no longer than 36 months at
- •the screening visit
- •5\. Patient treated with a stable dose of riluzole (100 mg/day) for at
- •least 30 days prior to screening
Exclusion Criteria
- •1\. Patient with history of hematologic, hepatic, respiratory disorder
- •that is clinically significant for his/her participation in the study
- •2\. Patient who underwent tracheotomy and /or gastrostomy
- •3\. Patient with a diagnosis of cancer or evidence of continued disease
- •within five years before starting study treatment
- •4\. Patient with significant sensory abnormalities, dementia, other
- •neurologic diseases, uncompensated medical illness and psychiatric
- •5\. Patient who have participated in a clinical trial within 3 months prior
- •to screening
- •6\. Pregnant, or nursing female patient
Outcomes
Primary Outcomes
Not specified
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