Clinical Trial: Pilot Study of Minocycline in Huntington's Disease

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multi-Center, Double-Blind, Pilot Study of Minocycline in Huntington's Disease

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 Summary: 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.
Sponsor: Merit Cudkowicz

Current Primary Outcome: Change From Baseline to Month 18 in the Total Functional Capacity (TFC) Scale [LOCF Imputation Method] [ Time Frame: 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).


Original Primary Outcome: Establish preliminary estimate of minocycline's impact on progression of HD (measured by the change in TFC score of UHDRS'99 between baseline & Month 18), and to assess futility of further study of the agent.

Current Secondary Outcome: Change From Baseline to Month 18 in the Total Functional Capacity (TFC) Scale [Regression Based Multiple Imputation Method] [ Time Frame: 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.


Original Secondary Outcome: To collect additional data on safety/tolerability to plan future efficacy trial of minocycline.

Information By: Huntington Study Group

Dates:
Date Received: January 12, 2006
Date Started: April 2006
Date Completion:
Last Updated: April 17, 2013
Last Verified: April 2013