Minocycline in Patients With Huntington's Disease - Tabular View

Tracking Information
First Received Date ^ICMJE	January 24, 2002
Last Updated Date	June 23, 2005
Start Date ^ICMJE	September 2001
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00029874 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Minocycline in Patients With Huntington's Disease
Official Title ^ICMJE	Minocycline Dosing and Safety in Huntington's Disease
Brief Summary	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.
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.
Study Phase	Phase I, Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study
Condition ^ICMJE	Huntington's Disease
Intervention ^ICMJE	Drug: Minocycline
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	63
Completion Date	August 2003
Primary Completion Date
Eligibility Criteria ^ICMJE	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)
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00029874
Responsible Party
Study ID Numbers ^ICMJE	FD-R-1968-01
Study Sponsor ^ICMJE	FDA Office of Orphan Products Development
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	FDA Office of Orphan Products Development
Verification Date	December 2004
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP