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

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00886977
• Other study ID #: YAM80-01
• Status: Active, not recruiting
• Phase: Phase 2
• First received: April 21, 2009
• Last updated: October 22, 2010
• Start date: April 2009

Study information

• 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

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

Drug:
• YAM80
Oral administration, 2 to 6 mg, once a day.

Locations

Country	Name	City	State
Japan	Yoshino Neurology Clinic	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Yoshino Neurology Clinic

Country where clinical trial is conducted

Japan, 

Outcome

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