Pilot Study of Minocycline in Huntington's Disease
Information source: Huntington Study Group
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Huntington Disease
Intervention: minocycline (Drug)
Phase: Phase 2/Phase 3
Status: Active, not recruiting
Sponsored by: Huntington Study Group
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.
Official title: A Multi-Center, Double-Blind, Pilot Study of Minocycline in Huntington's Disease
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study
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.
Secondary outcome: To collect additional data on safety/tolerability to plan future efficacy trial of minocycline.
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
Minimum age: 18 Years.
Maximum age: N/A.
- Age 18 years or older
- Clinical features of HD and a confirmatory family history of HD; and/or genetically
- Independently walking and fully self-sufficient in activities of daily living (eating,
- Able to take medication (capsules) by mouth
- History of known hypersensitivity or intolerability to minocycline or known allergy to
- 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 South Florida, Tampa, Florida, United States
University of Florida, Gainesville, 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
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.
Huntington Study Group. Minocycline safety and tolerability in Huntington disease. Neurology. 2004 Aug 10;63(3):547-9.
Starting date: January 2006
Ending date: October 2008
Last updated: December 31, 2007