Back to resultsEfficacy and Safety of YAM80 in Amyotrophic Lateral Sclerosis (ALS)
Primary Purpose
Amyotrophic Lateral Sclerosis
Status
Unknown status
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
YAM80
Sponsored by
About this trial
This is an interventional treatment trial for Amyotrophic Lateral Sclerosis focused on measuring ALS
Eligibility 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
Sites / Locations
- Yoshino Neurology Clinic
Outcomes
Primary Outcome Measures
ALSFRS-R
Safety
Secondary Outcome Measures
Manual Muscle Testing
Grip/pinch strength
Pulmonary function (forced vital capacity)
Full Information
NCT ID
NCT00886977
First Posted
April 21, 2009
Last Updated
October 22, 2010
Sponsor
Yoshino Neurology Clinic
1. Study Identification
Unique Protocol Identification Number
NCT00886977
Brief Title
Efficacy and Safety of YAM80 in Amyotrophic Lateral Sclerosis (ALS)
Official Title
Pilot-Study of YAM80 in Amyotrophic Lateral Sclerosis. Evaluation of the Efficacy and Safety of YAM80 in Amyotrophic Lateral Sclerosis (ALS)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Unknown status
Study Start Date
April 2009 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Yoshino Neurology Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The efficacy and safety are evaluated when YAM80 is administered orally to the patients of Amyotrophic Lateral Sclerosis (ALS).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis
Keywords
ALS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
YAM80
Intervention Description
Oral administration, 2 to 6 mg, once a day.
Primary Outcome Measure Information:
Title
ALSFRS-R
Time Frame
24w + follow-up period
Title
Safety
Time Frame
24w and the follow up period
Secondary Outcome Measure Information:
Title
Manual Muscle Testing
Time Frame
24w + follow-up period
Title
Grip/pinch strength
Time Frame
24w + followup period
Title
Pulmonary function (forced vital capacity)
Time Frame
24w + follow-up period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hiide Yoshino, M.D.
Organizational Affiliation
Yoshino Neurology Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yoshino Neurology Clinic
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of YAM80 in Amyotrophic Lateral Sclerosis (ALS)
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