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

This study is ongoing, but not recruiting participants.
Information provided by:
Yoshino Neurology Clinic
ClinicalTrials.gov Identifier:
First received: April 21, 2009
Last updated: October 22, 2010
Last verified: April 2009
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: 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:

Further study details as provided by Yoshino Neurology Clinic:

Primary Outcome Measures:
  • ALSFRS-R [ Time Frame: 24w + follow-up period ]
  • Safety [ Time Frame: 24w and the follow up period ]

Secondary Outcome Measures:
  • 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 ]

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.

Ages Eligible for Study:   25 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00886977

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

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

Keywords provided by Yoshino Neurology Clinic:

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

ClinicalTrials.gov processed this record on January 19, 2017