Pilot Study of Minocycline in Huntington's Disease
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.
Drug: Matching placebo
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Multi-Center, Double-Blind, Pilot Study of Minocycline in Huntington's Disease|
- Change From Baseline to Month 18 in the Total Functional Capacity (TFC) Scale [LOCF Imputation Method] [ Time Frame: Baseline to 18 months ] [ Designated as safety issue: No ]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).
- Change From Baseline to Month 18 in the Total Functional Capacity (TFC) Scale [Regression Based Multiple Imputation Method] [ Time Frame: Baseline to 18 months ] [ Designated as safety issue: No ]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.
|Study Start Date:||April 2006|
|Study Completion Date:||November 2008|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
Minocycline (3:1 randomization) 100 mg capsules taken by mouth twice daily, 200 mg per day total for 18 months treatment duration.
Minocycline: Oral; minocycline 100 mg capsules administered twice a day with the morning and evening meal (~ 8 hours apart)
Placebo Comparator: Matching placebo
Sugar pill manufactured to mimic minocycline, 1 capsule taken by mouth twice daily for 18 months treatment duration.
Drug: Matching placebo
Matching placebo 1 capsule twice daily, 18 months treatment duration.
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.
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States|
|United States, Colorado|
|Colorado Neurological Institute|
|Englewood, Colorado, United States|
|United States, Florida|
|University of Florida|
|Gainesville, Florida, United States|
|University of South Florida|
|Tampa, Florida, United States|
|United States, Maryland|
|University of Maryland School of Medicine|
|Baltimore, Maryland, United States|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States|
|United States, Missouri|
|Washington University School of Medicine|
|St. Louis, Missouri, United States|
|United States, New York|
|Albany Medical College|
|Albany, New York, United States|
|New York, New York, United States|
|University of Rochester|
|Rochester, New York, United States|
|United States, Texas|
|University of Texas Medical Branch at Galveston|
|Galveston, Texas, United States|
|Canada, British Columbia|
|University of British Columbia|
|Vancouver, British Columbia, Canada|
|Principal Investigator:||Merit E. Cudkowicz, MD||Massachusetts General Hospital|