Perampanel for Sporadic Amyotrophic Lateral Sclerosis (ALS)
- Registration Number
- NCT03019419
- Lead Sponsor
- Tokyo Medical University
- Brief Summary
To investigate the safety and the efficacy of perampanel in patients with sporadic amyotrophic lateral sclerosis
- Detailed Description
To evaluate the effect of peramanel for 48 weeks on progression of disease in subjects with ALS, as measured by ALS Functional Rating Scale-Revised (ALSFRS-R)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo placebo Once daily placebo for control for 48 weeks Perampanel 4mg Perampanel Once daily 4mg of perampanel with dose-escalation tolerable from 2mg to 4mg for 48 weeks Perampanel 8mg Perampanel Once daily 8mg of perampanel with dose-escalation tolerable from 2mg to 8mg for 48 weeks
- Primary Outcome Measures
Name Time Method Change in ALS Functional rating scale 48 weeks
- Secondary Outcome Measures
Name Time Method Change in ALS Functional rating scale 12, 24, 36, and 48 weeks Manual Muscle Test 12, 24, 36, and 48 weeks Percent-predicted forced vital capacity 12, 24, 36, and 48 weeks
Trial Locations
- Locations (12)
Shiga University of Medical Science Hospital
🇯🇵Shiga, Japan
Tokyo Medical University
🇯🇵Tokyo, Japan
Kitasato University East Hospital
🇯🇵Kanagawa, Japan
Kumamoto Saishunso National Hospital
🇯🇵Kumamoto, Japan
Nagoya University Hospital
🇯🇵Nagoya, Japan
Okayama University Hospital
🇯🇵Okayama, Japan
Hokkaido University Hospital
🇯🇵Sapporo, Japan
Tohoku University Hospital
🇯🇵Sendai, Japan
The University of Tokyo Hospital
🇯🇵Tokyo, Japan
University of Tsukuba Hospital
🇯🇵Tsukuba, Japan
Yamaguchi University Hospital
🇯🇵Yamaguchi, Japan
Tokyo Metropolitan Neurological Hospital
🇯🇵Tokyo, Japan