Pilot Study of Minocycline in Huntington's Disease

Merit Cudkowicz114 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

114

Conditions

Huntington Disease

Interventions

minocyclineDRUG

Minocycline: Oral; minocycline 100 mg capsules administered twice a day with the morning and evening meal (\~ 8 hours apart)

Matching placeboDRUG

Matching placebo 1 capsule twice daily, 18 months treatment duration.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Criteria: * 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)

Locations (12)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Colorado Neurological Institute

Englewood, Colorado, United States

University of Florida

Gainesville, Florida, United States

Outcomes

Primary Outcomes

Change From Baseline to Month 18 in the Total Functional Capacity (TFC) Scale [LOCF Imputation Method]

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).

Time frame: Baseline to 18 months

Secondary Outcomes

Change From Baseline to Month 18 in the Total Functional Capacity (TFC) Scale [Regression Based Multiple Imputation Method]

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.

Time frame: Baseline to 18 months

Data from ClinicalTrials.gov

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