Clincosm LogoSign in Get a demo

Minocycline in Patients With Huntington's Disease

Sponsor
FDA Office of Orphan Products Development (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT00029874
Collaborator
(none)
63
Enrollment
1
Location
23
Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

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
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.

Study Design

Study Type:
Interventional
Allocation:
Randomized
Masking:
Double
Primary Purpose:
Treatment
Official Title:
Minocycline Dosing and Safety in Huntington's Disease
Study Start Date :
Sep 1, 2001
Study Completion Date :
Aug 1, 2003

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Massachusetts General Hospital Boston Massachusetts United States 02114

    Sponsors and Collaborators

    • FDA Office of Orphan Products Development

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00029874
    Other Study ID Numbers:
    • FD-R-1968-01
    First Posted:
    Jan 25, 2002
    Last Update Posted:
    Mar 25, 2015
    Last Verified:
    Dec 1, 2004
    Keywords provided by , ,
    Tetracyclines
    Dose-Response Relationship, Drug
    Additional relevant MeSH terms:
    Huntington Disease
    Minocycline

    Study Results

    No Results Posted as of Mar 25, 2015