Minocycline in Patients With Huntington's Disease

Huntington's Disease Clinical Trial

Official title:

Minocycline Dosing and Safety in Huntington's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00029874
• Other study ID #: FD-R-1968-01
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 24, 2002
• Last updated: March 24, 2015
• Start date: September 2001
• Est. completion date: August 2003

Study information

• Verified date: December 2004
• Source: FDA Office of Orphan Products Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: August 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Huntington Disease
• Huntington's Disease

Intervention

Drug:
• Minocycline

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
FDA Office of Orphan Products Development

Country where clinical trial is conducted

United States,