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

October 22, 2010 updated by: Yoshino Neurology Clinic

Pilot-Study of YAM80 in Amyotrophic Lateral Sclerosis. Evaluation of the Efficacy and Safety of YAM80 in Amyotrophic Lateral Sclerosis (ALS)

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

Study Overview

Status

Unknown

Conditions

Amyotrophic Lateral Sclerosis

Intervention / Treatment

Drug: YAM80

Study Type

Interventional

Enrollment (Anticipated)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Japan
- - Tokyo, Japan
    - Yoshino Neurology Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
ALSFRS-R Time Frame: 24w + follow-up period	24w + follow-up period
Safety Time Frame: 24w and the follow up period	24w and the follow up period

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yoshino Neurology Clinic

Investigators

Principal Investigator: Hiide Yoshino, M.D., Yoshino Neurology Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

April 21, 2009

First Submitted That Met QC Criteria

April 22, 2009

First Posted (Estimate)

April 23, 2009

Study Record Updates

Last Update Posted (Estimate)

October 25, 2010

Last Update Submitted That Met QC Criteria

October 22, 2010

Last Verified