Minocycline in Patients With Huntington's Disease - Full Text View

Sponsor:	FDA Office of Orphan Products Development
Information provided by:	FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:	NCT00029874

Purpose

This is a study to determine whether treatment with minocycline is safe and tolerable in patients with Huntington's disease (HD) and whether minocycline reduces symptoms of HD in these patients.

Condition	Intervention	Phase
Huntington's Disease	Drug: Minocycline	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Minocycline Dosing and Safety 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 FDA Office of Orphan Products Development:

Estimated Enrollment:	63
Study Start Date:	September 2001
Estimated Study Completion Date:	August 2003

Detailed Description:

Huntington's disease (HD) is a dominantly inherited disorder. It is uniformly progressive and there is no known effective treatment or cure. The pathogenesis is largely unknown; however, recent studies implicate caspase activation, glutamate excitotoxicity, and free radical toxicity as possible causes of HD. Pharmacological agents that block these pathways may be therapeutic in HD. Minocycline is an antibiotic that also inhibits caspase-1 and caspase-3 expression, and inducible nitric oxide synthetase activity, which are factors that may play an important role in the mechanisms of neuropathology in HD.

Two dosages of minocycline or placebo will be given to ambulatory patients with HD over an 8-week period and the tolerability will be compared. Additional measures of safety and the change in motor, behavior, cognitive, and function features will be examined.

Eligibility

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

Criteria

Inclusion criteria:

Clinical features of Huntington's disease (HD) and a confirmatory family history of HD and/or a CAG repeat expansion of at least 37
Stage I, II, or III of illness (TFC greater than or equal to 5)
Ambulatory and not requiring skilled nursing care
Patients must use effective birth control
Concurrent psychotropic medications must be at stable dose for at least 4 weeks prior to study
WBC count at least 3,800/mm3
Creatinine no greater than 2.0
Alanine aminotransferase (ALT) no greater than 2 times upper limit of normal

Exclusion criteria:

Prior minocycline use within 2 months of baseline visit
History of known sensitivity or intolerability to minocycline or any other tetracycline
History of vestibular disease
Use of any investigational drug within 30 days of baseline visit
Treatment with any drug that may cause lupus-like symptoms (e.g., procainamide or hydralazine) within 4 weeks of baseline visit
Pregnant or nursing
Underlying hematologic, hepatic, or renal disease
Evidence of unstable medical illness
Illness that requires use of coumadin
Unstable psychiatric illness defined as psychosis (hallucinations or delusions), untreated major depression within 90 days of baseline visit, or suicidal ideation
Substance (alcohol or drug) abuse within 1 year of baseline visit
History of systemic lupus erythematosis (SLE) or a history of SLE in a first-degree relative
Positive ANA screening (at or above 1:80)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00029874

Locations

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

FDA Office of Orphan Products Development

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00029874 History of Changes
Other Study ID Numbers:	FD-R-1968-01
Study First Received:	January 24, 2002
Last Updated:	June 23, 2005
Health Authority:	United States: Food and Drug Administration

Keywords provided by FDA Office of Orphan Products Development:

Tetracyclines
Dose-Response Relationship, Drug

Additional relevant MeSH terms:

Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dementia
Chorea
Dyskinesias
Movement Disorders
Heredodegenerative Disorders, Nervous System

Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012