Minocycline in Patients With Huntington's Disease

This study has been completed.
Sponsor:
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
NCT00029874
First received: January 24, 2002
Last updated: June 23, 2005
Last verified: December 2004

January 24, 2002
June 23, 2005
September 2001
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Complete list of historical versions of study NCT00029874 on ClinicalTrials.gov Archive Site
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Minocycline in Patients With Huntington's Disease
Minocycline Dosing and Safety in Huntington's Disease

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Double-Blind
Primary Purpose: Treatment
Huntington's Disease
Drug: Minocycline
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
63
August 2003
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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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00029874
FD-R-1968-01
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FDA Office of Orphan Products Development
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Not Provided
FDA Office of Orphan Products Development
December 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP