Trial | NCT00886977  Report issue

Title

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)

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    yam80 ...

  • Study Participants

    25
The efficacy and safety are evaluated when YAM80 is administered orally to the patients of Amyotrophic Lateral Sclerosis (ALS).
Study Started
Apr 30
2009
Primary Completion
Dec 31
2010
Anticipated
Last Update
Oct 25
2010
Estimate

Drug YAM80

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

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
No Results Posted