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

NCT ID: NCT00886977

Last Updated: 2010-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Brief Summary

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

Detailed Description

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Conditions

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Amyotrophic Lateral Sclerosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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YAM80

Oral administration, 2 to 6 mg, once a day.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yoshino Neurology Clinic

OTHER

Sponsor Role lead

Responsible Party

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Yoshino Neurology Clinic

Principal Investigators

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Hiide Yoshino, M.D.

Role: PRINCIPAL_INVESTIGATOR

Yoshino Neurology Clinic

Locations

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Yoshino Neurology Clinic

Tokyo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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YAM80-01

Identifier Type: -

Identifier Source: org_study_id