Dutasteride to Treat Spinal and Bulbar Muscular Atrophy (SBMA)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00303446
• Date of registration: 15/03/2006
• Prospective Registration: No
• Primary sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
• Public title: Dutasteride to Treat Spinal and Bulbar Muscular Atrophy (SBMA)
• Scientific title: Phase II Clinical Trial to Examine the Efficacy and Safety of Dutasteride in Patients With Kennedy's Disease (Spinal and Bulbar Muscular Atrophy)
• Date of first enrolment: March 2006
• Target sample size: 57
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00303446
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Kenneth Fischbeck, M.D.
• Affiliation: NINDS, NIH

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Spinal and Bulbar Muscular Atrophy

Kennedy's Disease

Intervention(s)

Drug: Dutasteride

Drug: Placebo

Primary Outcome(s)

Muscle Strength Change From Baseline [Time Frame: 0, 12, and 24 months]

Secondary Outcome(s)

International Index for Erectile Function (IIEF), Change From Baseline [Time Frame: 0, 12, and 24 months]

Peroneal Compound Muscle Action Potential, Change From Baseline [Time Frame: 0, 12, and 24 months]

Sensory Nerve Action Potential Average, Change From Baseline [Time Frame: 0, 12, and 24 months]

Medical Outcomes Study 36-item Short Form Version 2 (SF-36v2) Mental Component Summary, Percent Change From Baseline [Time Frame: 0, 12, and 24 months]

Bulbar Rating Scale, Change From Baseline [Time Frame: 0, 12, and 24 months]

Median Compound Muscle Action Potential, Change From Baseline [Time Frame: 0, 12, and 24 months]

Medical Outcomes Study 36-item Short Form Version 2 (SF-36v2) Physical Component Summary, Change From Baseline [Time Frame: 0, 12, and 24 months]

Timed 2-minute Walk, Change From Baseline [Time Frame: 0, 12, and 24 months]

Adult Myopathy Assessment Tool, Change From Baseline [Time Frame: 0, 12, and 24 months]

Creatine Kinase, Change From Baseline [Time Frame: 0, 12, and 24 months]

Activities of Daily Living, Change From Baseline [Time Frame: 0, 12, and 24 months]

Manual Muscle Testing, Change From Baseline. [Time Frame: 0, 12, and 24 months]

Motor Unit Nerve Estimation, Change From Baseline [Time Frame: 0, 12, and 24 months]

Swallow Score Average, Change From Baseline [Time Frame: 0, 12, and 24 months]

Secondary ID(s)

060113

06-N-0113

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 22/06/2010
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00303446