Status:
COMPLETED
Dutasteride to Treat Spinal and Bulbar Muscular Atrophy (SBMA)
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Kennedy's Disease
Spinal and Bulbar Muscular Atrophy
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
This study will determine if the drug dutasteride can improve weakness, mobility, functioning, nerve function, and quality of life in patients with spinal and bulbar muscular atrophy (SBMA). Patients ...
Detailed Description
Background: Spinal and bulbar muscular atrophy (SBMA) or Kennedy's disease is a slowly progressive, X-linked motor neuron disease for which there is currently no treatment. It is caused by a mutation...
Eligibility Criteria
Inclusion
- Genetically confirmed SBMA
- Neurological symptoms of SBMA
- Ability to ambulate 100 feet with or without the use of assistive devices
- Willingness to participate in all aspects of trial design and follow-up
- Male sex
Exclusion
- Age less than 18 years
- Female sex
- A history of hypersensitivity to dutasteride or 5 alpha-reductase inhibitors.
- Exposure to 5 alpha-reductase inhibitors, anti-androgens, testosterone, or steroids in the preceding 6 months
- Patients who are taking potent cytochrome P450 3A4 (CYP3A4) inhibitors for over 4 weeks
- Patients with any pre-existing liver disease
- Alkaline phosphatase, gamma glutamyl transferase, or direct bilirubin greater than 1.5 times the upper limit of normal
- Alanine aminotransferase or aspartate aminotransferase greater than 1.5 times upper limit of normal in subjects with normal creatine kinase levels
- Creatinine greater than 1.5 times the upper limit of normal
- Platelet count, white blood cell count or hemoglobin below the lower limit of normal
- Other clinically significant medical disease that, in the judgment of the investigators, would expose the patient to undue risk of harm or prevent the patient from completing the study
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT00303446
Start Date
March 1 2006
End Date
December 1 2009
Last Update
January 27 2011
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892