Minocycline in Patients With Huntington's Disease
Information source: FDA Office of Orphan Products Development
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Huntington's Disease
Intervention: Minocycline (Drug)
Phase: Phase 1/Phase 2
Status: Completed
Sponsored by: FDA Office of Orphan Products Development
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.
Clinical Details
Official title: Minocycline Dosing and Safety in Huntington's Disease
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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)
Locations and Contacts
Massachusetts General Hospital, Boston, Massachusetts 02114, United States
Additional Information
Starting date: September 2001
Ending date: August 2003
Last updated: June 23, 2005
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