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Dutasteride to Treat Spinal and Bulbar Muscular Atrophy (SBMA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00303446
Recruitment Status : Completed
First Posted : March 16, 2006
Results First Posted : June 22, 2010
Last Update Posted : January 27, 2011
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Kennedy's Disease
Spinal and Bulbar Muscular Atrophy
Interventions Drug: Dutasteride
Drug: Placebo
Enrollment 57
Recruitment Details 57 subjects were evaluated at the National Institutes of Health (NIH) Clinical Center.
Pre-assignment Details 7 subjects were excluded on the basis of screening blood test abnormalities. 50 subjects were randomized.
Arm/Group Title Placebo Dutasteride
Hide Arm/Group Description Matched placebo, one tablet daily Dutasteride 500 micrograms, one tablet daily.
Period Title: Overall Study
Started 25 25
Completed 23 21
Not Completed 2 4
Reason Not Completed
Withdrawal by Subject             2             2
Death             0             1
Physician Decision             0             1
Arm/Group Title Placebo Dutasteride Total
Hide Arm/Group Description Matched placebo, one tablet daily Dutasteride 500 micrograms, one tablet daily. Total of all reporting groups
Overall Number of Baseline Participants 25 25 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
21
  84.0%
21
  84.0%
42
  84.0%
>=65 years
4
  16.0%
4
  16.0%
8
  16.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 25 participants 50 participants
53.5  (9.2) 51.9  (10.5) 53.1  (9.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
25
 100.0%
25
 100.0%
50
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants 25 participants 50 participants
25 25 50
1.Primary Outcome
Title Muscle Strength Change From Baseline
Hide Description Quantitative muscle assessment (QMA) was done with a fixed frame dynamometer, a strain gauge tensiometer, and a computer-aided acquisition system. Maximal voluntary isometric muscle contractions were measured twice, the average was calculated, and the results were summed over 22 muscle groups (11 on each side). The total force was scaled for body weight and expressed as percent change from baseline. Measurements were performed at 0, 12, and 24 months. The calculated percent changes at 12 and 24 months are shown.
Time Frame 0, 12, and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The participants analyzed were those who were available for analysis at 12 and 24 months.
Arm/Group Title Placebo Dutasteride
Hide Arm/Group Description:
Matched placebo, one tablet daily
Dutasteride 500 micrograms, one tablet daily.
Overall Number of Participants Analyzed 23 21
Mean (Standard Deviation)
Unit of Measure: percent change
Muscle Strength Change From Baseline at 12 Months -2.2  (9.4) 3.1  (27.1)
Muscle Strength Change From Baseline at 24 Months -4.5  (13.5) 1.3  (24.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dutasteride
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.28
Comments [Not Specified]
Method Generalized estimating equation model
Comments The analysis includes percent change from baseline at 12 and 24 months.
2.Secondary Outcome
Title Creatine Kinase, Change From Baseline
Hide Description Serum creatine kinase was determined in venous blood samples analyzed at the Department of Laboratory Medicine of the NIH Clinical Center.
Time Frame 0, 12, and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Dutasteride
Hide Arm/Group Description:
Matched placebo, one tablet daily
Dutasteride 500 micrograms, one tablet daily.
Overall Number of Participants Analyzed 23 21
Mean (Standard Deviation)
Unit of Measure: Units/liter
Creatine kinase change at 12 months -36  (360) -32  (375)
Creatine kinase change at 24 months -19  (494) -62  (472)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dutasteride
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.86
Comments [Not Specified]
Method Generalized estimating equation model
Comments The analysis includes change from baseline at 12 and 24 months.
3.Secondary Outcome
Title Manual Muscle Testing, Change From Baseline.
Hide Description Manual muscle testing was performed using a modified Medical Research Council (MRC) scale (0=worst, 5=best); the average muscle score was based on 22 muscle groups.
Time Frame 0, 12, and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Dutasteride
Hide Arm/Group Description:
Matched placebo, one tablet daily
Dutasteride 500 micrograms, one tablet daily.
Overall Number of Participants Analyzed 23 21
Mean (Standard Deviation)
Unit of Measure: MRC units on a scale
Manual Muscle Testing, Change at 12 months 0.04  (0.7) -0.25  (0.8)
Manual Muscle Testing, Change at 24 months 0.02  (0.7) 0.01  (0.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dutasteride
Comments Comparison of changes from baseline in manual muscle testing results.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.47
Comments [Not Specified]
Method Generalized estimating equation model
Comments The analysis includes change from baseline at 12 and 24 months.
4.Secondary Outcome
Title Adult Myopathy Assessment Tool, Change From Baseline
Hide Description The Adult Myopathy Assessment Tool rates physical function and muscle endurance, with higher scores indicating better performance; it includes 7 timed functional tasks and 6 endurance tasks (0=worst, 45=best).
Time Frame 0, 12, and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Dutasteride
Hide Arm/Group Description:
Matched placebo, one tablet daily
Dutasteride 500 micrograms, one tablet daily.
Overall Number of Participants Analyzed 23 21
Mean (Standard Deviation)
Unit of Measure: units on a scale
Adult Myopathy Assessment Tool, Change at 12 mos. -2.2  (3.7) -0.7  (2.4)
Adult Myopathy Assessment Tool, Change at 24 mos. -2.8  (4.2) -1.5  (3.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dutasteride
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.13
Comments [Not Specified]
Method Generalized estimating equation model
Comments The analysis includes change from baseline at 12 and 24 months.
5.Secondary Outcome
Title Timed 2-minute Walk, Change From Baseline
Hide Description The subjects did the 2-minute walk in a 50-foot (15.2-meter) corridor three times, and the average distance was calculated. The subjects were allowed to use an assistive device and rest between the trials.
Time Frame 0, 12, and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Dutasteride
Hide Arm/Group Description:
Matched placebo, one tablet daily
Dutasteride 500 micrograms, one tablet daily.
Overall Number of Participants Analyzed 23 21
Mean (Standard Deviation)
Unit of Measure: meters
Timed 2-minute Walk, Change at 12 months 8.1  (29.8) -0.8  (28.5)
Timed 2-minute Walk, Change at 24 months 2.2  (32.6) -1.6  (29.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dutasteride
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.46
Comments [Not Specified]
Method Generalized estimating equation model
Comments The analysis includes change from baseline at 12 and 24 months.
6.Secondary Outcome
Title Swallow Score Average, Change From Baseline
Hide Description Modified barium swallow studies were done at 0, 12, and 24 months. Twenty-five domains were assessed, and six were chosen for final analysis based on the abnormal findings in subjects evaluated at baseline: vallecular pooling and repeated-swallow, each assessed with thin liquids, purees, and solids (rated 1-4, abnormal to normal).
Time Frame 0, 12, and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Dutasteride
Hide Arm/Group Description:
Matched placebo, one tablet daily
Dutasteride 500 micrograms, one tablet daily.
Overall Number of Participants Analyzed 23 21
Mean (Standard Deviation)
Unit of Measure: units on a scale
Swallow Score Average, Change at 12 months -0.25  (0.4) 0.06  (0.6)
Swallow Score Average, Change at 24 months -0.53  (0.5) -0.14  (0.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dutasteride
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.11
Comments [Not Specified]
Method Generalized estimating equation model
Comments The analysis includes change from baseline at 12 and 24 months.
7.Secondary Outcome
Title Bulbar Rating Scale, Change From Baseline
Hide Description The Bulbar Rating Scale includes eight domains each rated on a 1-4 scale, abnormal to normal. The original 8-32 point scale was transformed to a 0-100% scale to represent the responses as percentages.
Time Frame 0, 12, and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Dutasteride
Hide Arm/Group Description:
Matched placebo, one tablet daily
Dutasteride 500 micrograms, one tablet daily.
Overall Number of Participants Analyzed 23 21
Mean (Standard Deviation)
Unit of Measure: percentage of maximum score
Bulbar Rating Scale, Change at 12 months 5.7  (6.7) 2.6  (6.8)
Bulbar Rating Scale, Change at 24 months 6.4  (5.8) 3.9  (4.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dutasteride
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.08
Comments [Not Specified]
Method Generalized estimating equation model
Comments The analysis includes change from baseline at 12 and 24 months.
8.Secondary Outcome
Title Sensory Nerve Action Potential Average, Change From Baseline
Hide Description Nerve conduction studies were done on four sensory nerves (median, ulnar, radial, sural), and the amplitudes of the evoked responses were averaged. Loss of amplitude indicates impairment of conduction.
Time Frame 0, 12, and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Dutasteride
Hide Arm/Group Description:
Matched placebo, one tablet daily
Dutasteride 500 micrograms, one tablet daily.
Overall Number of Participants Analyzed 23 21
Mean (Standard Deviation)
Unit of Measure: microVolts
Sensory Nerve Action Potential, Change at 12 mos. 0  (1) 0  (1)
Sensory Nerve Action Potential, Change at 24 mos. 0  (1) 0  (1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dutasteride
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.73
Comments [Not Specified]
Method Generalized estimating equation model
Comments The analysis includes change from baseline at 12 and 24 months.
9.Secondary Outcome
Title Median Compound Muscle Action Potential, Change From Baseline
Hide Description Nerve conduction studies were done on the median motor nerve, and the compound muscle action potential amplitude was determined. Loss of amplitude indicates impairment of conduction.
Time Frame 0, 12, and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Dutasteride
Hide Arm/Group Description:
Matched placebo, one tablet daily
Dutasteride 500 micrograms, one tablet daily.
Overall Number of Participants Analyzed 23 21
Mean (Standard Deviation)
Unit of Measure: mVolts
Median Motor Action Potential, Change at 12 months 0.04  (2.15) 0.52  (2.63)
Median Motor Action Potential, Change at 24 months -0.24  (1.84) 0.24  (1.89)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dutasteride
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.37
Comments [Not Specified]
Method Generalized estimating equation model
Comments The analysis includes change from baseline at 12 and 24 months.
10.Secondary Outcome
Title Peroneal Compound Muscle Action Potential, Change From Baseline
Hide Description Nerve conduction studies were done on the peroneal nerve, and the compound muscle action potential amplitude was determined. Loss of amplitude indicates impairment of conduction.
Time Frame 0, 12, and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Dutasteride
Hide Arm/Group Description:
Matched placebo, one tablet daily
Dutasteride 500 micrograms, one tablet daily.
Overall Number of Participants Analyzed 23 21
Mean (Standard Deviation)
Unit of Measure: mVolts
Peroneal Motor Action Potential, Change at 12 mos. 0.16  (1.07) 0.02  (0.84)
Peroneal Motor Action Potential, Change at 24 mos. 0.15  (1.37) 0.04  (0.81)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dutasteride
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.65
Comments [Not Specified]
Method Generalized estimating equation model
Comments The analysis includes change from baseline at 12 and 24 months.
11.Secondary Outcome
Title Motor Unit Nerve Estimation, Change From Baseline
Hide Description Motor unit number estimation (MUNE) was done with a statistical MUNE program, on the abductor pollicis brevis. All subjects were evaluated on the right side unless severe atrophy produced very low compound muscle action potentials; in this case, the left side was investigated or the abductor digiti minimi was substituted. A decrease in MUNE indicates a loss of motor units.
Time Frame 0, 12, and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Dutasteride
Hide Arm/Group Description:
Matched placebo, one tablet daily
Dutasteride 500 micrograms, one tablet daily.
Overall Number of Participants Analyzed 23 21
Mean (Standard Deviation)
Unit of Measure: motor unit number
Motor Unit Nerve Estimation, Change at 12 months -4.2  (18.9) -4.2  (18.7)
Motor Unit Nerve Estimation, Change at 24 months -2.2  (23.3) -2.6  (17.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dutasteride
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.99
Comments [Not Specified]
Method Generalized estimating equation model
Comments The analysis includes change from baseline at 12 and 24 months.
12.Secondary Outcome
Title Activities of Daily Living, Change From Baseline
Hide Description Subjects rated their daily activity with a modified 9-question Activities of Daily Living (ADL) questionnaire (0-4, fully impaired to normal).
Time Frame 0, 12, and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Dutasteride
Hide Arm/Group Description:
Matched placebo, one tablet daily
Dutasteride 500 micrograms, one tablet daily.
Overall Number of Participants Analyzed 23 21
Mean (Standard Deviation)
Unit of Measure: units on a scale
Activities of Daily Living, Change at 12 months 0.4  (2.3) 0.4  (2.8)
Activities of Daily Living, Change at 24 months 1.2  (3.3) 1.1  (4.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dutasteride
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments [Not Specified]
Method Generalized estimating equation model
Comments The analysis includes change from baseline at 12 and 24 months.
13.Secondary Outcome
Title Medical Outcomes Study 36-item Short Form Version 2 (SF-36v2) Physical Component Summary, Change From Baseline
Hide Description Subjects completed the Medical Outcomes Study Short Form Version 2 (SF-36v2), in which they rated their physical quality of life over the preceding 4 weeks. Raw SF-36v2 scores were converted to norm-based scales and component summaries using the scoring code provided by QualityMetric (mean=50, standard deviation (SD)=10).
Time Frame 0, 12, and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Dutasteride
Hide Arm/Group Description:
Matched placebo, one tablet daily
Dutasteride 500 micrograms, one tablet daily.
Overall Number of Participants Analyzed 23 21
Mean (Standard Deviation)
Unit of Measure: percent change
SF-36v2 Physical Component Sum., Change at 12 mos. -0.9  (6.5) 2.5  (5.9)
SF-36v2 Physical Component Sum., Change at 24 mos. -3.6  (8.4) 2.1  (6.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dutasteride
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
Comments [Not Specified]
Method Generalized estimating equation model
Comments The analysis includes change from baseline at 12 and 24 months.
14.Secondary Outcome
Title Medical Outcomes Study 36-item Short Form Version 2 (SF-36v2) Mental Component Summary, Percent Change From Baseline
Hide Description Subjects completed the Medical Outcomes Study Short Form Version 2 (SF-36v2), in which they rated their mental quality of life over the preceding 4 weeks. Raw SF-36v2 scores were converted to norm-based scales and component summaries using the scoring code provided by QualityMetric (mean=50, standard deviation (SD)=10), and percent change in the norm-based scale was calculated.
Time Frame 0, 12, and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Dutasteride
Hide Arm/Group Description:
Matched placebo, one tablet daily
Dutasteride 500 micrograms, one tablet daily.
Overall Number of Participants Analyzed 23 21
Mean (Standard Deviation)
Unit of Measure: percent change
SF-36v2 Mental Component Sum., Change at 12 mos. 0.6  (11.1) 0.1  (7.9)
SF-36v2 Mental Component Sum., Change at 24 mos. 3.3  (9.3) -3.2  (10.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dutasteride
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.033
Comments Generalized estimating equation model showed a significant interaction between time and treatment; therefore a two sample t-test was used at each time point. P-value is given for comparison at 24 months.
Method t-test, 2 sided
Comments [Not Specified]
15.Secondary Outcome
Title International Index for Erectile Function (IIEF), Change From Baseline
Hide Description Sexual function was rated using the International Index of Erectile Function (IIEF). The total IIEF score (5-75, worst-best) was reported as the percent maximum (0-100%).
Time Frame 0, 12, and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Dutasteride
Hide Arm/Group Description:
Matched placebo, one tablet daily
Dutasteride 500 micrograms, one tablet daily.
Overall Number of Participants Analyzed 23 21
Mean (Standard Deviation)
Unit of Measure: percent of maximum score
IIEF, Change at 12 months -2.4  (10.2) -2.1  (11.6)
IIEF, Change at 24 months -0.3  (16.4) -3.5  (6.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dutasteride
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.61
Comments [Not Specified]
Method Generalized estimating equation model
Comments The analysis includes change from baseline at 12 and 24 months.
Time Frame 24 months
Adverse Event Reporting Description Subjects reported the severity and type of adverse events at each visit.
 
Arm/Group Title Placebo Dutasteride
Hide Arm/Group Description Matched placebo, one tablet daily Dutasteride 500 micrograms, one tablet daily.
All-Cause Mortality
Placebo Dutasteride
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Dutasteride
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/25 (8.00%)      5/25 (20.00%)    
Cardiac disorders     
cardiac failure * [1]  0/25 (0.00%)  0 1/25 (4.00%)  1
Gastrointestinal disorders     
gastroenteritis * [2]  0/25 (0.00%)  0 1/25 (4.00%)  1
Musculoskeletal and connective tissue disorders     
fall requiring hospitalization *  2/25 (8.00%)  4 2/25 (8.00%)  2
Respiratory, thoracic and mediastinal disorders     
respiratory failure * [3]  0/25 (0.00%)  0 1/25 (4.00%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Death from a probable cardiac event.
[2]
Dehydration requiring hospitalization.
[3]
Subject developed serious respiratory difficulties and was removed from the study.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Dutasteride
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   23/25 (92.00%)      23/25 (92.00%)    
Cardiac disorders     
cardiac events *  3/25 (12.00%)  3 1/25 (4.00%)  1
Endocrine disorders     
endocrine *  0/25 (0.00%)  0 2/25 (8.00%)  2
Gastrointestinal disorders     
gastrointestinal *  5/25 (20.00%)  8 7/25 (28.00%)  26
General disorders     
constitutional symptoms *  3/25 (12.00%)  4 6/25 (24.00%)  14
ear-nose-throat *  11/25 (44.00%)  16 10/25 (40.00%)  20
hematologic *  3/25 (12.00%)  3 2/25 (8.00%)  2
musculoskeletal *  18/25 (72.00%)  109 11/25 (44.00%)  73
genitourinary *  1/25 (4.00%)  2 3/25 (12.00%)  3
Hepatobiliary disorders     
hepatic *  0/25 (0.00%)  0 2/25 (8.00%)  3
Infections and infestations     
infectious *  12/25 (48.00%)  312 14/25 (56.00%)  26
Nervous system disorders     
neurologic *  15/25 (60.00%)  34 15/25 (60.00%)  39
Skin and subcutaneous tissue disorders     
dermatologic *  3/25 (12.00%)  3 4/25 (16.00%)  6
*
Indicates events were collected by non-systematic assessment
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
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 ( Other Identifier: NINDS IRB protocol number )
First Submitted: March 15, 2006
First Posted: March 16, 2006
Results First Submitted: December 9, 2009
Results First Posted: June 22, 2010
Last Update Posted: January 27, 2011