DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Pilot Study of Minocycline in Huntington's Disease

Information source: Huntington Study Group
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Huntington Disease

Intervention: minocycline (Drug)

Phase: Phase 2/Phase 3

Status: Active, not recruiting

Sponsored by: Huntington Study Group

Official(s) and/or principal investigator(s):
Merit E. Cudkowicz, MD, Principal Investigator, Affiliation: Massachusetts General Hospital

Summary

This study is being conducted to assess the impact of minocycline on the progression of symptoms of HD. The study will also assess whether it is reasonable to continue with further study of minocycline in HD. We will measure the effect of minocycline on HD by measuring the change in Huntington's disease symptoms.

Clinical Details

Official title: A Multi-Center, Double-Blind, Pilot Study of Minocycline in Huntington's Disease

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study

Primary outcome: Establish preliminary estimate of minocycline's impact on progression of HD (measured by the change in TFC score of UHDRS'99 between baseline & Month 18), and to assess futility of further study of the agent.

Secondary outcome: To collect additional data on safety/tolerability to plan future efficacy trial of minocycline.

Detailed description: The DOMINO study is a randomized, double-blind, multi-center, futility study of minocycline in patients with HD. Subjects will be randomized (3: 1) to one of the two study arms: (1) the group that receives active minocycline (100 mg po b. i.d.), and (2) the group that receives placebo. Subjects will be enrolled over an approximate six-month period and remain on blinded study drug for 18 months. The primary analysis will involve a comparison of the change over time in TFC between the minocycline group and a fixed value determined from historical control data. A placebo group will also be included to facilitate blinding and to permit a descriptive assessment of the validity of the assumed change over time in historical controls.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Age 18 years or older

- Clinical features of HD and a confirmatory family history of HD; and/or genetically

confirmed HD

- Independently walking and fully self-sufficient in activities of daily living (eating,

dressing, bathing)

- Able to take medication (capsules) by mouth

Exclusion Criteria:

- History of known hypersensitivity or intolerability to minocycline or known allergy to

any tetracycline

- History of vestibular disease

- Subjects with underlying hematologic, hepatic or renal disease

- History of systemic lupus erythematosus (SLE)

Locations and Contacts

University of Alabama at Birmingham, Birmingham, Alabama, United States

University of British Columbia, Vancouver, British Columbia, Canada

Colorado Neurological Institute, Englewood, Colorado, United States

University of South Florida, Tampa, Florida, United States

University of Florida, Gainesville, Florida, United States

University of Maryland School of Medicine, Baltimore, Maryland, United States

Massachusetts General Hospital, Boston, Massachusetts, United States

Washington University School of Medicine, St. Louis, Missouri, United States

Albany Medical College, Albany, New York, United States

Columbia University, New York, New York, United States

University of Rochester, Rochester, New York, United States

University of Texas Medical Branch at Galveston, Galveston, Texas, United States

Additional Information

The Huntington Study Group (HSG) is a non-profit group of physicians and other health care providers from medical centers in the U.S., Canada, Europe and Australia, experienced in the care of Huntington patients and dedicated to clinical research of HD.

Related publications:

Huntington Study Group. Minocycline safety and tolerability in Huntington disease. Neurology. 2004 Aug 10;63(3):547-9.

Starting date: January 2006
Ending date: October 2008
Last updated: December 31, 2007

Page last updated: June 20, 2008

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2014