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Dutasteride to Treat Spinal and Bulbar Muscular Atrophy (SBMA)

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00303446
First received: March 15, 2006
Last updated: January 25, 2011
Last verified: January 2011
Results First Received: December 9, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Kennedy's Disease
Spinal and Bulbar Muscular Atrophy
Interventions: Drug: Dutasteride
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
57 subjects were evaluated at the National Institutes of Health (NIH) Clinical Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
7 subjects were excluded on the basis of screening blood test abnormalities. 50 subjects were randomized.

Reporting Groups
  Description
Placebo Matched placebo, one tablet daily
Dutasteride Dutasteride 500 micrograms, one tablet daily.

Participant Flow:   Overall Study
    Placebo     Dutasteride  
STARTED     25     25  
COMPLETED     23     21  
NOT COMPLETED     2     4  
Withdrawal by Subject                 2                 2  
Death                 0                 1  
Physician Decision                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Matched placebo, one tablet daily
Dutasteride Dutasteride 500 micrograms, one tablet daily.
Total Total of all reporting groups

Baseline Measures
    Placebo     Dutasteride     Total  
Number of Participants  
[units: participants]
  25     25     50  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     21     21     42  
>=65 years     4     4     8  
Age  
[units: years]
Mean ± Standard Deviation
  53.5  ± 9.2     51.9  ± 10.5     53.1  ± 9.5  
Gender  
[units: participants]
     
Female     0     0     0  
Male     25     25     50  
Region of Enrollment  
[units: participants]
     
United States     25     25     50  



  Outcome Measures
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1.  Primary:   Muscle Strength Change From Baseline   [ Time Frame: 0, 12, and 24 months ]

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

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

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

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

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

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

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

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

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

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

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

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

14.  Secondary:   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 ]

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Kenneth Fischbeck, M.D.
Organization: National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH)
phone: 301-435-9318
e-mail: kf@ninds.nih.gov


Publications of Results:

Responsible Party: Kenneth H. Fischbeck, M.D./National Institute of Neurological Disorders and Stroke, National Institutes of Health
ClinicalTrials.gov Identifier: NCT00303446     History of Changes
Other Study ID Numbers: 060113, 06-N-0113
Study First Received: March 15, 2006
Results First Received: December 9, 2009
Last Updated: January 25, 2011
Health Authority: United States: Federal Government