Minocycline in Patients With Huntington's Disease

• Status: Completed
• Trial end date: 2003-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: FDA Office of Orphan Products Development
• Treatments: Minocycline

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)