Pilot Study of Minocycline in Huntington's Disease
- Registration Number
- NCT00277355
- Lead Sponsor
- Merit Cudkowicz
- 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 minocycline in HD. We will measure the effect of minocycline on HD by measuring the change in Huntington's disease symptoms.
- 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 receives active minocycline (100 mg po b.i.d.), and (2) the group that receives placebo. Subjects will be enrolled over an approximate six-month period and remain on blinded study drug for 18 months. The primary analysis will involve a comparison of the change over time in TFC between the minocycline group and a fixed value determined from historical control data. A placebo group will also be included to facilitate blinding and to permit a descriptive assessment of the validity of the assumed change over time in historical controls.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 114
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Matching placebo Matching placebo Sugar pill manufactured to mimic minocycline, 1 capsule taken by mouth twice daily for 18 months treatment duration. Minocycline minocycline Minocycline (3:1 randomization) 100 mg capsules taken by mouth twice daily, 200 mg per day total for 18 months treatment duration.
- Primary Outcome Measures
Name Time Method Change From Baseline to Month 18 in the Total Functional Capacity (TFC) Scale [LOCF Imputation Method] Baseline to 18 months Establish preliminary estimate of minocycline's impact on progression of HD (measured by the change in Total Functional Capacity (TFC) score of Unified Huntington's Disease Rating Scale \[UHDRS\] between baseline \& Month 18), and to assess futility of further study of minocycline. TFC consists of five ordinally scaled items assessing a person's capacity with: 1. occupation 2. financial affairs 3. domestic responsibilities 4. activities of daily living and 5. independent living. Total score ranges from zero (worst) to 13 (best).
- Secondary Outcome Measures
Name Time Method Change From Baseline to Month 18 in the Total Functional Capacity (TFC) Scale [Regression Based Multiple Imputation Method] Baseline to 18 months TFC consists of five ordinally scaled items assessing a person's capacity with: (1) occupation; (2) financial affairs; (3) domestic responsibilities; (4) activities of daily living; and (5) independent living. Total score ranges from zero (worst) to 13 (best). Regression based imputation was used to impute missing values.
Trial Locations
- Locations (12)
Washington University School of Medicine
🇺🇸St. Louis, Missouri, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
University of South Florida
🇺🇸Tampa, Florida, United States
Colorado Neurological Institute
🇺🇸Englewood, Colorado, United States
University of Maryland School of Medicine
🇺🇸Baltimore, Maryland, United States
University of Texas Medical Branch at Galveston
🇺🇸Galveston, Texas, United States
University of British Columbia
🇨🇦Vancouver, British Columbia, Canada
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Columbia University
🇺🇸New York, New York, United States
University of Rochester
🇺🇸Rochester, New York, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Albany Medical College
🇺🇸Albany, New York, United States