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

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

NCT00886977•Yoshino Neurology Clinic

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

25 - 65 years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Yoshino Neurology Clinic

Tokyo, Japan

Key Dates

Start Date

April 1, 2009

Primary Completion Date

December 1, 2010

Last Updated

October 25, 2010

Enrollment

ESTIMATED participants

Conditions

Amyotrophic Lateral Sclerosis

Interventions

YAM80

DRUG

Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS

NCT07322003

Amyotrophic Lateral Sclerosis

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RECRUITING

Intermuscular Coherence as a Biomarker for ALS

NCT05104710

Amyotrophic Lateral Sclerosis

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RECRUITINGNA

Connect-One: Early Feasibility Study of Connexus® Brain-Computer Interface (BCI)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 25, 2010Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS

Intermuscular Coherence as a Biomarker for ALS

Connect-One: Early Feasibility Study of Connexus® Brain-Computer Interface (BCI)

UPenn Observational Research Repository on Neurodegenerative Disease

Control Cohort CTRL COH

Identifying Biomarkers in ALS Patients Using Neuronal Derived Extracellular Vesicles