Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Boston, Massachusetts 02114


Purpose:

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 summary:

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.


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)


Study is Available At:


Original ID:

FD-R-1968-01


NCT ID:

NCT00029874


Secondary ID:


Study Acronym:


Brief Title:

Minocycline in Patients With Huntington's Disease


Official Title:

Minocycline Dosing and Safety in Huntington's Disease


Overall Status:

Completed


Study Phase:

Phase 1/Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

FDA Office of Orphan Products Development


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

63


Enrollment Type:


Study Dates

Start Date:September 2001
Completion Date:August 2003
Verification Date:December 2004
Last Changed Date:March 24, 2015
First Received Date:January 24, 2002

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Minocycline

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:U.S. Fed
Agency Type:Lead Sponsor
Agency Name:FDA Office of Orphan Products Development

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.