Clinical trial NCT00277355: Pilot Study of Minocycline in Huntington's Disease
Official title: A Multi-Center, Double-Blind, Pilot Study of Minocycline in Huntington's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Huntington Disease
Keywords: Study of Minocycline in Huntington's Disease
Lead sponsor: Huntington Study Group
Sponsor class: NETWORK
Collaborators: name: FDA Office of Orphan Products Development
First posted: 2006-01-16
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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)

Primary outcomes:
measure: Change From Baseline to Month 18 in the Total Functional Capacity (TFC) Scale [LOCF Imputation Method]
timeFrame: Baseline to 18 months
Secondary outcomes:
measure: Change From Baseline to Month 18 in the Total Functional Capacity (TFC) Scale [Regression Based Multiple Imputation Method]
timeFrame: Baseline to 18 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Englewood
country: United States
facility: Colorado Neurological Institute
state: Colorado
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Baltimore
country: United States
facility: University of Maryland School of Medicine
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Galveston
country: United States
facility: University of Texas Medical Branch at Galveston
state: Texas
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
Study officials:
affiliation: Massachusetts General Hospital
name: Merit E. Cudkowicz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Huntington Study Group. Minocycline safety and tolerability in Huntington disease. Neurology. 2004 Aug 10;63(3):547-9. doi: 10.1212/01.wnl.0000133403.30559.ff.