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
  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 1
Phase 2

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
  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
Chorea
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Dyskinesias
Genetic Diseases, Inborn
Heredodegenerative Disorders, Nervous System
Mental Disorders
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014