Dutasteride to Treat Spinal and Bulbar Muscular Atrophy (SBMA)
Kennedy's Disease, Spinal and Bulbar Muscular Atrophy
About this trial
This is an interventional treatment trial for Kennedy's Disease focused on measuring Motor Neuron, Androgen Receptor, Polyglutamine, X-Linked, Ligand Dependency, Spinal and Bulbar Muscular Atrophy, SBMA, Kennedy Disease
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Sites / Locations
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Dutasteride
Placebo
Dutasteride 0.5 mg/day
Matched placebo