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Minocycline in Patients With Huntington's Disease

Primary Purpose

Huntington's Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Minocycline
Sponsored by
FDA Office of Orphan Products Development
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Huntington's Disease focused on measuring Tetracyclines, Dose-Response Relationship, Drug

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Massachusetts General Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 24, 2002
Last Updated
March 24, 2015
Sponsor
FDA Office of Orphan Products Development
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1. Study Identification

Unique Protocol Identification Number
NCT00029874
Brief Title
Minocycline in Patients With Huntington's Disease
Official Title
Minocycline Dosing and Safety in Huntington's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
December 2004
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
FDA Office of Orphan Products Development

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Huntington's Disease
Keywords
Tetracyclines, Dose-Response Relationship, Drug

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Masking
Double
Allocation
Randomized
Enrollment
63 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Minocycline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

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Minocycline in Patients With Huntington's Disease

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