Efficacy and Safety of YAM80 in Amyotrophic Lateral Sclerosis (ALS)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00886977
• Date of registration: 21/04/2009
• Prospective Registration: No
• Primary sponsor: Yoshino Neurology Clinic
• Public title: Efficacy and Safety of YAM80 in Amyotrophic Lateral Sclerosis (ALS)
• Scientific title: Pilot-Study of YAM80 in Amyotrophic Lateral Sclerosis. Evaluation of the Efficacy and Safety of YAM80 in Amyotrophic Lateral Sclerosis (ALS)
• Date of first enrolment: April 2009
• Target sample size: 25
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00886977
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Japan

Contacts

• Name: Hiide Yoshino, M.D.
• Affiliation: Yoshino Neurology Clinic

Key inclusion & exclusion criteria

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



Age minimum: 25 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Amyotrophic Lateral Sclerosis

Intervention(s)

Drug: YAM80

Primary Outcome(s)

Safety [Time Frame: 24w and the follow up period]

ALSFRS-R [Time Frame: 24w + follow-up period]

Secondary Outcome(s)

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]

Secondary ID(s)

YAM80-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors