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Clinical Trials/NCT00886977
NCT00886977UnknownPhase 2

Pilot-Study of YAM80 in Amyotrophic Lateral Sclerosis. Evaluation of the Efficacy and Safety of YAM80 in Amyotrophic Lateral Sclerosis (ALS)

Yoshino Neurology Clinic1 site in 1 country25 target enrollmentStarted: April 2009Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Enrollment
25
Locations
1
Primary Endpoint
ALSFRS-R
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
25 Years to 65 Years (Adult, Older Adult)
Sex
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

Outcomes

Primary Outcomes

ALSFRS-R

Time Frame: 24w + follow-up period

Safety

Time Frame: 24w and the follow up period

Secondary Outcomes

  • Manual Muscle Testing(24w + follow-up period)
  • Grip/pinch strength(24w + followup period)
  • Pulmonary function (forced vital capacity)(24w + follow-up period)

Investigators

Sponsor Class
Other

Study Sites (1)

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