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Minocycline in Patients With Huntington's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00029874
Recruitment Status : Completed
First Posted : January 25, 2002
Last Update Posted : March 25, 2015
Information provided by:
FDA Office of Orphan Products Development

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.

Condition or disease Intervention/treatment Phase
Huntington's Disease Drug: Minocycline Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 63 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Official Title: Minocycline Dosing and Safety in Huntington's Disease
Study Start Date : September 2001
Study Completion Date : August 2003

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00029874

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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
FDA Office of Orphan Products Development
Layout table for additonal information Identifier: NCT00029874    
Other Study ID Numbers: FD-R-1968-01
First Posted: January 25, 2002    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: December 2004
Keywords provided by FDA Office of Orphan Products Development:
Dose-Response Relationship, Drug
Additional relevant MeSH terms:
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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