Status:
COMPLETED
Pilot Study of Minocycline in Huntington's Disease
Lead Sponsor:
Merit Cudkowicz
Collaborating Sponsors:
FDA Office of Orphan Products Development
Conditions:
Huntington Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
This study is being conducted to assess the impact of minocycline on the progression of symptoms of HD. The study will also assess whether it is reasonable to continue with further study of minocyclin...
Detailed Description
The DOMINO study is a randomized, double-blind, multi-center, futility study of minocycline in patients with HD. Subjects will be randomized (3:1) to one of the two study arms: (1) the group that rece...
Eligibility Criteria
Inclusion
- Age 18 years or older
- Clinical features of HD and a confirmatory family history of HD; and/or genetically confirmed HD
- Independently walking and fully self-sufficient in activities of daily living (eating, dressing, bathing)
- Able to take medication (capsules) by mouth
Exclusion
- History of known hypersensitivity or intolerability to minocycline or known allergy to any tetracycline
- History of vestibular disease
- Subjects with underlying hematologic, hepatic or renal disease
- History of systemic lupus erythematosus (SLE)
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT00277355
Start Date
April 1 2006
End Date
November 1 2008
Last Update
April 19 2013
Active Locations (12)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States
2
Colorado Neurological Institute
Englewood, Colorado, United States
3
University of Florida
Gainesville, Florida, United States
4
University of South Florida
Tampa, Florida, United States