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Sponsored by: |
National Institute of Neurological Disorders and Stroke (NINDS) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00303446 |
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 with this inherited disease have an abnormal androgen receptor protein. The male hormones testosterone and dihydrotestosterone (DHT) bind to this abnormal receptor, causing damage to nerve cells that innervate muscle and leading to weakness.
Dutasteride decreases DHT production. Lowering DHT levels may decrease the harmful effects of DHT to the nerves and improve strength in people with SBMA.
Males 18 years of age and older with SBMA who have neurological symptoms and can walk 100 feet (with or without assistive devices) may be eligible for this study. Candidates are screened with a blood test and a review of their medical records and genetic studies.
Participants undergo the following procedures:
Condition | Intervention | Phase |
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Kennedy's Disease Spinal and Bulbar Muscular Atrophy |
Procedure: Neurological Testing Drug: Dutasteride |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | Phase II Clinical Trial to Examine the Efficacy and Safety of Dutasteride in Patients With Kennedy's Disease (Spinal and Bulbar Muscular Atrophy) |
Estimated Enrollment: | 60 |
Study Start Date: | March 2006 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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 CYP3A4 inhibitors for over 4 weeks.
Patients with any pre-existing liver disease.
Alkaline phosphatase, GGT, or direct bilirubin greater than 1.5 X the upper limit of normal.
SGOT or SGPT greater than 1.5 X upper limit of normal in subjects with normal CK levels.
Creatinine greater than 1.5 X 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.
Responsible Party: | National Institutes of Health ( Kenneth H. Fischbeck, M.D./National Institute of Neurological Disorders and Stroke ) |
Study ID Numbers: | 060113, 06-N-0113 |
Study First Received: | March 15, 2006 |
Last Updated: | March 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00303446 History of Changes |
Health Authority: | United States: Federal Government |
Motor Neuron Androgen Receptor Polyglutamine X-Linked |
Ligand Dependency Spinal and Bulbar Muscalr Atrophy SBMA Kennedy Disease |
Dutasteride Pathological Conditions, Anatomical Signs and Symptoms Kennedy Disease |
Neurologic Manifestations Atrophy Muscular Atrophy Androgens |
Dutasteride Pathological Conditions, Anatomical Signs and Symptoms Neuromuscular Manifestations Molecular Mechanisms of Pharmacological Action Nervous System Diseases |
Neurologic Manifestations Enzyme Inhibitors Atrophy Pharmacologic Actions Muscular Atrophy |