Perampanel for sporadic amyotrophic lateral sclerosis (ALS): A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 Trial
- Conditions
- Sporadic amyotrophic lateral sclerosis
- Registration Number
- JPRN-UMIN000025614
- Lead Sponsor
- Department of Neurology, Tokyo Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 66
Not provided
- Patients who underwent tracheostomy. - Patients who experienced non-invasive positive pressure ventilation. - Patients whose percent-predicted forced vital capacity (%FVC) is <80%. - Patients with progressive bulbar palsy type. - Patients with cognitive impairment, severe disease in the renal, cardiovascular, or hematological system. - Patients with hepatic disease. - Patients with malignant tumor. - Pregnant women or women with a possibility of becoming pregnant. - Patients who participated in another clinical study within 12 weeks before starting the observation period. - Patients who has initiated perampanel therapy in the past or at present. - Patients who are judged to be ineligible for study entry by the investigators.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the effect of perampanel on progression of the disease in subjects with ALS, as measured by the ALS Functional Rating Scale -Revised (ALSFRS-R). [Time Frame: 48 weeks.] [Designated as safety issue: Yes]
- Secondary Outcome Measures
Name Time Method Change in ALSFRS-R slope [Time Frame: Every 12 weeks.] [Designated as safety issue: Yes] Manual Muscle Test (MMT) [Time Frame: Every 12 weeks.] [Designated as safety issue: Yes] Percent-predicted forced vital capacity (%FVC) [Time Frame: Every 12 weeks.] [Designated as safety issue: Yes]