Pilot Study of Minocycline in Huntington's Disease

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Huntington Disease	Drug: minocycline; Drug: Matching placebo	Phase 2; Phase 3

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.

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	114 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	A Multi-Center, Double-Blind, Pilot Study of Minocycline in Huntington's Disease
Study Start Date :	April 2006
Actual Primary Completion Date :	October 2008
Actual Study Completion Date :	November 2008

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Minocycline; Minocycline (3:1 randomization) 100 mg capsules taken by mouth twice daily, 200 mg per day total for 18 months treatment duration.	Drug: minocycline; Minocycline: Oral; minocycline 100 mg capsules administered twice a day with the morning and evening meal (~ 8 hours apart)
Placebo Comparator: Matching placebo; Sugar pill manufactured to mimic minocycline, 1 capsule taken by mouth twice daily for 18 months treatment duration.	Drug: Matching placebo; Matching placebo 1 capsule twice daily, 18 months treatment duration.

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Change From Baseline to Month 18 in the Total Functional Capacity (TFC) Scale [LOCF Imputation Method] [ Time Frame: Baseline to 18 months ]
   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).

Secondary Outcome Measures :

1. Change From Baseline to Month 18 in the Total Functional Capacity (TFC) Scale [Regression Based Multiple Imputation Method] [ Time Frame: Baseline to 18 months ]
   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.

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

Merit Cudkowicz

FDA Office of Orphan Products Development

Investigators

Principal Investigator:	Merit E. Cudkowicz, MD	Massachusetts General Hospital

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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. 

Publications:

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

Responsible Party:	Merit Cudkowicz, Principal Investigator, Huntington Study Group
ClinicalTrials.gov Identifier:	NCT00277355 History of Changes
Other Study ID Numbers:	FD-R-002588; DOMINO
First Posted:	January 16, 2006
Results First Posted:	April 19, 2013
Last Update Posted:	April 19, 2013
Last Verified:	April 2013

Keywords provided by Merit Cudkowicz, Huntington Study Group:

Study of Minocycline in Huntington's Disease

Additional relevant MeSH terms:

Huntington Disease; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Chorea; Dyskinesias; Movement Disorders	Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Minocycline; Anti-Bacterial Agents; Anti-Infective Agents