Status:
UNKNOWN
Efficacy and Safety of YAM80 in Amyotrophic Lateral Sclerosis (ALS)
Lead Sponsor:
Yoshino Neurology Clinic
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
25-65 years
Phase:
PHASE2
Brief Summary
The efficacy and safety are evaluated when YAM80 is administered orally to the patients of Amyotrophic Lateral Sclerosis (ALS).
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00886977
Start Date
April 1 2009
Last Update
October 25 2010
Active Locations (1)
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1
Yoshino Neurology Clinic
Tokyo, Japan