NCT00886977

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

April 21, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 23, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Last Updated

October 25, 2010

Status Verified

April 1, 2009

Enrollment Period

1.7 years

First QC Date

April 21, 2009

Last Update Submit

October 22, 2010

Conditions

Amyotrophic Lateral Sclerosis

Keywords

ALS

Outcome Measures

Primary Outcomes (2)

  • ALSFRS-R

    24w + follow-up period

  • Safety

    24w and the follow up period

Secondary Outcomes (3)

  • Manual Muscle Testing

    24w + follow-up period

  • Grip/pinch strength

    24w + followup period

  • Pulmonary function (forced vital capacity)

    24w + follow-up period

Interventions

YAM80DRUG

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

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yoshino Neurology Clinic

Tokyo, Japan

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Hiide Yoshino, M.D.

    Yoshino Neurology Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 21, 2009

First Posted

April 23, 2009

Study Start

April 1, 2009

Primary Completion

December 1, 2010

Last Updated

October 25, 2010

Record last verified: 2009-04

Locations

JP(1)