Minocycline in Patients With Huntington's Disease

March 24, 2015 updated by: FDA Office of Orphan Products Development

Minocycline Dosing and Safety in Huntington's Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

63

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

FDA Office of Orphan Products Development

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2001

Study Completion

August 1, 2003

Study Registration Dates

First Submitted

January 24, 2002

First Submitted That Met QC Criteria

January 24, 2002

First Posted (Estimate)

January 25, 2002

Study Record Updates

Last Update Posted (Estimate)

March 25, 2015

Last Update Submitted That Met QC Criteria

March 24, 2015

Last Verified

December 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FD-R-1968-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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