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Minocycline in Patients With Huntington's Disease

This study has been completed.
Information provided by:
FDA Office of Orphan Products Development Identifier:
First received: January 24, 2002
Last updated: March 24, 2015
Last verified: December 2004
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 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Official Title: Minocycline Dosing and Safety in Huntington's Disease

Resource links provided by NLM:

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00029874

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
FDA Office of Orphan Products Development
  More Information Identifier: NCT00029874     History of Changes
Other Study ID Numbers: FD-R-1968-01
Study First Received: January 24, 2002
Last Updated: March 24, 2015

Keywords provided by FDA Office of Orphan Products Development:
Dose-Response Relationship, Drug

Additional relevant MeSH terms:
Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Anti-Bacterial Agents
Anti-Infective Agents processed this record on September 21, 2017