Minocycline in Patients With Huntington's Disease

Completed · Phase 1/Phase 2

Conditions studied: Huntington's Disease

In brief

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.

Key facts

Study ID

NCT00029874

Run by

FDA Office of Orphan Products Development

People needed

63

Starts

2001-09-01

Expected to finish

2003-08-01

Last updated by the study team

2015-03-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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