Amyotrophic Lateral Sclerosis
Conditions
Keywords
ALS
Brief summary
The efficacy and safety are evaluated when YAM80 is administered orally to the patients of Amyotrophic Lateral Sclerosis (ALS).
Interventions
DRUGYAM80
Oral administration, 2 to 6 mg, once a day.
Sponsors
Yoshino Neurology Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ALSFRS-R | 24w + follow-up period |
| Safety | 24w and the follow up period |
Secondary
| Measure | Time frame |
|---|---|
| Manual Muscle Testing | 24w + follow-up period |
| Grip/pinch strength | 24w + followup period |
| Pulmonary function (forced vital capacity) | 24w + follow-up period |
Countries
Japan
Outcome results
None listed