Overview

This trial is active, not recruiting.

Condition amyotrophic lateral sclerosis
Treatment yam80
Phase phase 2
Sponsor Yoshino Neurology Clinic
Start date April 2009
End date December 2010
Trial size 25 participants
Trial identifier NCT00886977, YAM80-01

Summary

The efficacy and safety are evaluated when YAM80 is administered orally to the patients of Amyotrophic Lateral Sclerosis (ALS).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
ALSFRS-R
time frame: 24w + follow-up period
Safety
time frame: 24w and the follow up period

Secondary Outcomes

Measure
Manual Muscle Testing
time frame: 24w + follow-up period
Grip/pinch strength
time frame: 24w + followup period
Pulmonary function (forced vital capacity)
time frame: 24w + follow-up period

Eligibility Criteria

Male or female participants from 25 years up to 65 years old.

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

Additional Information

Official title Pilot-Study of YAM80 in Amyotrophic Lateral Sclerosis. Evaluation of the Efficacy and Safety of YAM80 in Amyotrophic Lateral Sclerosis (ALS)
Principal investigator Hiide Yoshino, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in October 2010.
Information provided to ClinicalTrials.gov by Yoshino Neurology Clinic.