Pilot Study of Minocycline in Huntington's Disease

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

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.

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.

Intervention(s) in this Clinical Trial

• Drug: minocycline
  • Minocycline: Oral; minocycline 100 mg capsules or matching placebo administered twice a day with the morning and evening meal (~ 8 hours apart)

Primary Measures

• 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.
  • Time Frame: 18 months
    Safety Issue?: No

Secondary Measures

• To collect additional data on safety/tolerability to plan future efficacy trial of minocycline.
  • Time Frame: 18 months
    Safety Issue?: Yes

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)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Huntington Study Group Other

Overall Clinical Trial Officials and Contacts

Merit E. Cudkowicz, MD Principal Investigator Massachusetts General Hospital  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00277355

Study ID Number: FD-R-002588

ClinicalTrials.gov Identifier: NCT00277355

Health Authority: United States: Food and Drug Administration

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.