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Dutasteride in Kennedy's Disease
NCT00303446Phase 2
Key facts
- Status
- Completed
- Start
- Mar 2006
- Primary completion
- Dec 2009
- Countries
- 1
- Sponsor
- National Institute of Neurological Disorders and Stroke
- Modality
- Small Molecules
- Drugs
- dutasteride
- Conditions
- spinal and bulbar muscular atrophy (SBMA)
01
Overview
Phase 2, randomised, double-blind trial in spinal and bulbar muscular atrophy (SBMA) comparing Dutasteride with Placebo (2 arms). Primary endpoint: Muscle Strength Change From Baseline (Quantitative Muscle Testing) at 24 months. Started Mar 2006; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Dutasteride
Dutasteride 0.5 mg/day
Placebo
Matched placebo
03
Who it enrols
Adult males with genetically confirmed SBMA who can walk 100 feet. Excludes those with liver disease, recent use of 5-ARIs or androgens, or significant lab abnormalities.
04
Endpoints
Primary
Muscle Strength Change From Baseline (Quantitative Muscle Testing)
Secondary
Creatine Kinase Change From Baseline
Manual Muscle Testing Change From Baseline
Adult Myositis Assessment Tool Change From Baseline
Timed 2-minute Walk Change From Baseline
Swallow Score Average Change From Baseline
Bulbar Rating Scale Change From Baseline
Sensory Nerve Action Potential Average Change From Baseline
Median/Peroneal Compound Muscle Action Potential Change From Baseline
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