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Pilot Study of Minocycline in Huntington's Disease

Information source: Huntington Study Group
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Huntington Disease

Intervention: minocycline (Drug); Matching placebo (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Merit Cudkowicz

Official(s) and/or principal investigator(s):
Merit E. Cudkowicz, MD, Principal Investigator, Affiliation: Massachusetts General Hospital


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

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

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

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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 and Contacts

University of Alabama at Birmingham, Birmingham, Alabama, United States

University of British Columbia, Vancouver, British Columbia, Canada

Colorado Neurological Institute, Englewood, Colorado, United States

University of Florida, Gainesville, Florida, United States

University of South Florida, Tampa, Florida, United States

University of Maryland School of Medicine, Baltimore, Maryland, United States

Massachusetts General Hospital, Boston, Massachusetts, United States

Washington University School of Medicine, St. Louis, Missouri, United States

Albany Medical College, Albany, New York, United States

Columbia University, New York, New York, United States

University of Rochester, Rochester, New York, United States

University of Texas Medical Branch at Galveston, Galveston, Texas, United States

Additional Information

The Huntington Study Group (HSG) is a non-profit group of physicians and other health care providers from medical centers in the U.S., Canada, Europe and Australia, experienced in the care of Huntington patients and dedicated to clinical research of HD.

Related publications:

Huntington Study Group. Minocycline safety and tolerability in Huntington disease. Neurology. 2004 Aug 10;63(3):547-9.

Starting date: April 2006
Last updated: April 17, 2013

Page last updated: August 23, 2015

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