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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2009 by Yoshino Neurology Clinic.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00886977
First Posted: April 23, 2009
Last Update Posted: October 25, 2010
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.
Information provided by:
Yoshino Neurology Clinic
  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: 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)

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Hiide Yoshino, Clinic Director, Yoshino Neurology Clinic
ClinicalTrials.gov Identifier: NCT00886977     History of Changes
Other Study ID Numbers: YAM80-01
First Submitted: April 21, 2009
First Posted: April 23, 2009
Last Update Posted: October 25, 2010
Last Verified: April 2009

Keywords provided by Yoshino Neurology Clinic:
ALS

Additional relevant MeSH terms:
Sclerosis
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