Pilot Study of Minocycline in Huntington's Disease

Huntington Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00277355
• Other study ID #: FD-R-002588
• Secondary ID: DOMINO
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 12, 2006
• Last updated: April 17, 2013
• Start date: April 2006
• Est. completion date: November 2008

Study information

• Verified date: April 2013
• Source: Huntington Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: November 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Huntington Disease

Intervention

Drug:
• minocycline
Minocycline: Oral; minocycline 100 mg capsules administered twice a day with the morning and evening meal (~ 8 hours apart)
• Matching placebo
Matching placebo 1 capsule twice daily, 18 months treatment duration.

Locations

Country	Name	City	State
Canada	University of British Columbia	Vancouver	British Columbia
United States	Albany Medical College	Albany	New York
United States	University of Maryland School of Medicine	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Colorado Neurological Institute	Englewood	Colorado
United States	University of Florida	Gainesville	Florida
United States	University of Texas Medical Branch at Galveston	Galveston	Texas
United States	Columbia University	New York	New York
United States	University of Rochester	Rochester	New York
United States	Washington University School of Medicine	St. Louis	Missouri
United States	University of South Florida	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Merit Cudkowicz	FDA Office of Orphan Products Development

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to Month 18 in the Total Functional Capacity (TFC) Scale [LOCF Imputation Method]	Establish preliminary estimate of minocycline's impact on progression of HD (measured by the change in Total Functional Capacity (TFC) score of Unified Huntington's Disease Rating Scale [UHDRS] between baseline & Month 18), and to assess futility of further study of minocycline. TFC consists of five ordinally scaled items assessing a person's capacity with: 1. occupation 2. financial affairs 3. domestic responsibilities 4. activities of daily living and 5. independent living. Total score ranges from zero (worst) to 13 (best).	Baseline to 18 months	No
Secondary	Change From Baseline to Month 18 in the Total Functional Capacity (TFC) Scale [Regression Based Multiple Imputation Method]	TFC consists of five ordinally scaled items assessing a person's capacity with: (1) occupation; (2) financial affairs; (3) domestic responsibilities; (4) activities of daily living; and (5) independent living. Total score ranges from zero (worst) to 13 (best). Regression based imputation was used to impute missing values.	Baseline to 18 months	No

External Links

•   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.