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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00886977
Recruitment Status : Unknown
Verified April 2009 by Yoshino Neurology Clinic.
Recruitment status was:  Active, not recruiting
First Posted : April 23, 2009
Last Update Posted : October 25, 2010
Information provided by:
Yoshino Neurology Clinic

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

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Drug: YAM80 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : April 2009
Estimated Primary Completion Date : December 2010

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

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

Secondary Outcome Measures :
  1. Manual Muscle Testing [ Time Frame: 24w + follow-up period ]
  2. Grip/pinch strength [ Time Frame: 24w + followup period ]
  3. Pulmonary function (forced vital capacity) [ Time Frame: 24w + follow-up period ]

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00886977

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

Responsible Party: Hiide Yoshino, Clinic Director, Yoshino Neurology Clinic Identifier: NCT00886977     History of Changes
Other Study ID Numbers: YAM80-01
First Posted: April 23, 2009    Key Record Dates
Last Update Posted: October 25, 2010
Last Verified: April 2009

Keywords provided by Yoshino Neurology Clinic:

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