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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Yoshino Neurology Clinic.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Yoshino Neurology Clinic
ClinicalTrials.gov Identifier:
NCT00886977
First received: April 21, 2009
Last updated: October 22, 2010
Last verified: April 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Amyotrophic Lateral Sclerosis
 Drug: YAM80
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot-Study of YAM80 in Amyotrophic Lateral Sclerosis. Evaluation of the Efficacy and Safety of YAM80 in Amyotrophic Lateral Sclerosis (ALS)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yoshino Neurology Clinic:

Primary Outcome Measures:
  • ALSFRS-R [ Time Frame: 24w + follow-up period ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: 24w and the follow up period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Manual Muscle Testing [ Time Frame: 24w + follow-up period ] [ Designated as safety issue: No ]
  • Grip/pinch strength [ Time Frame: 24w + followup period ] [ Designated as safety issue: No ]
  • Pulmonary function (forced vital capacity) [ Time Frame: 24w + follow-up period ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 25
Study Start Date: April 2009
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: YAM80
    Oral administration, 2 to 6 mg, once a day.
  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00886977

Locations
Japan
Yoshino Neurology Clinic
Tokyo, Japan
Sponsors and Collaborators
Yoshino Neurology Clinic
Investigators
Principal Investigator: Hiide Yoshino, M.D. Yoshino Neurology Clinic
  More Information

No publications provided

Responsible Party: Hiide Yoshino, Clinic Director, Yoshino Neurology Clinic
ClinicalTrials.gov Identifier: NCT00886977     History of Changes
Other Study ID Numbers: YAM80-01
Study First Received: April 21, 2009
Last Updated: October 22, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Yoshino Neurology Clinic:
ALS

Additional relevant MeSH terms:
Amyotrophic Lateral Sclerosis
Sclerosis
Motor Neuron Disease
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
 Neurodegenerative Diseases
TDP-43 Proteinopathies
Neuromuscular Diseases
Proteostasis Deficiencies
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013