Efficacy and Safety of YAM80 in Amyotrophic Lateral Sclerosis (ALS)
Phase 2
- Conditions
- Amyotrophic Lateral Sclerosis
- Registration Number
- NCT00886977
- Lead Sponsor
- Yoshino Neurology Clinic
- Brief Summary
The efficacy and safety are evaluated when YAM80 is administered orally to the patients of Amyotrophic Lateral Sclerosis (ALS).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria
- Patients aged between 25 and 65 years
- ALS patients who can visit the clinic for six months
- Forced Vital Capacity (FVC) > 70%
- Patients who can walk by themselves
- Change in ALSFRS-R score from -1 to -4 during 12 weeks before the initial administration
- Patients who are willing to give informed consent
Exclusion Criteria
- Tracheotomy and invasive ventilation
- Pregnant or possibly pregnant female patients
- Female patients of childbearing potential who cannot practice contraception during and two years after the administration, and male patients who cannot practice contraception during and six months after the administration
- Patients with clinically significant conditions such as cardiovascular, respiratory, haematological, and renal diseases.
- Patients who are being treated with investigational drugs
- Patients who are treated with other ALS drugs within 2 weeks prior to the first administration
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method ALSFRS-R 24w + follow-up period Safety 24w and the follow up period
- Secondary Outcome Measures
Name Time Method Manual Muscle Testing 24w + follow-up period Grip/pinch strength 24w + followup period Pulmonary function (forced vital capacity) 24w + follow-up period
Trial Locations
- Locations (1)
Yoshino Neurology Clinic
🇯🇵Tokyo, Japan