Pilot Study of Minocycline in Huntington's Disease - Full Text View

Sponsor:	Huntington Study Group
Collaborator:	FDA Office of Orphan Products Development
Information provided by:	Huntington Study Group
ClinicalTrials.gov Identifier:	NCT00277355

Purpose

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.

Condition	Intervention	Phase
Huntington Disease	Drug: minocycline	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Multi-Center, Double-Blind, Pilot Study of Minocycline in Huntington's Disease

Resource links provided by NLM:

Genetics Home Reference related topics: chorea-acanthocytosis familial paroxysmal nonkinesigenic dyskinesia Huntington disease McLeod neuroacanthocytosis syndrome

MedlinePlus related topics: Huntington's Disease

Drug Information available for: Minocycline Minocycline hydrochloride

U.S. FDA Resources

Further study details as provided by Huntington Study Group:

Primary Outcome Measures:

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. [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To collect additional data on safety/tolerability to plan future efficacy trial of minocycline. [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Enrollment:	114
Study Start Date:	January 2006
Estimated Study Completion Date:	October 2008
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Intervention Details:

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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00277355

Locations

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 South Florida
Tampa, Florida, United States
University of Florida
Gainesville, 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
Columbia University
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

Sponsors and Collaborators

Huntington Study Group

FDA Office of Orphan Products Development

Investigators

Principal Investigator:

Merit E. Cudkowicz, MD

Massachusetts General Hospital

More Information

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. This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications:

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

Responsible Party:	Massachusetts General Hospital ( Merit Cudkowicz, MD, MsC/Huntington Study Group Principal Investigator )
Study ID Numbers:	FD-R-002588, DOMINO
Study First Received:	January 12, 2006
Last Updated:	December 31, 2007
ClinicalTrials.gov Identifier:	NCT00277355 History of Changes
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by Huntington Study Group:

Study of Minocycline in Huntington's Disease

Additional relevant MeSH terms:

Anti-Infective Agents
Minocycline
Basal Ganglia Diseases
Nervous System Diseases
Central Nervous System Diseases
Brain Diseases
Neurodegenerative Diseases
Dyskinesias
Pharmacologic Actions
Cognition Disorders

Chorea
Anti-Bacterial Agents
Delirium, Dementia, Amnestic, Cognitive Disorders
Heredodegenerative Disorders, Nervous System
Genetic Diseases, Inborn
Mental Disorders
Movement Disorders
Therapeutic Uses
Dementia
Huntington Disease

ClinicalTrials.gov processed this record on February 08, 2010