Amyotrophic Lateral Sclerosis Clinical Trial
Official title:
Pilot-Study of YAM80 in Amyotrophic Lateral Sclerosis. Evaluation of the Efficacy and Safety of YAM80 in Amyotrophic Lateral Sclerosis (ALS)
Verified date | April 2009 |
Source | Yoshino Neurology Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | Japan: Ministry of Health, Labor and Welfare |
Study type | Interventional |
The efficacy and safety are evaluated when YAM80 is administered orally to the patients of Amyotrophic Lateral Sclerosis (ALS).
Status | Active, not recruiting |
Enrollment | 25 |
Est. completion date | |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 25 Years to 65 Years |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Japan | Yoshino Neurology Clinic | Tokyo |
Lead Sponsor | Collaborator |
---|---|
Yoshino Neurology Clinic |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ALSFRS-R | 24w + follow-up period | No | |
Primary | Safety | 24w and the follow up period | Yes | |
Secondary | Manual Muscle Testing | 24w + follow-up period | No | |
Secondary | Grip/pinch strength | 24w + followup period | No | |
Secondary | Pulmonary function (forced vital capacity) | 24w + follow-up period | Yes |
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