Pilot Study of Minocycline in Huntington's Disease

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Merit Cudkowicz, Huntington Study Group
ClinicalTrials.gov Identifier:
NCT00277355
First received: January 12, 2006
Last updated: April 17, 2013
Last verified: April 2013
  Purpose

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 Intervention Phase
Huntington Disease
Drug: minocycline
Drug: Matching placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-Center, Double-Blind, Pilot Study of Minocycline in Huntington's Disease

Resource links provided by NLM:


Further study details as provided by Huntington Study Group:

Primary Outcome Measures:
  • Change From Baseline to Month 18 in the Total Functional Capacity (TFC) Scale [LOCF Imputation Method] [ Time Frame: Baseline to 18 months ] [ Designated as safety issue: No ]
    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:
  • Change From Baseline to Month 18 in the Total Functional Capacity (TFC) Scale [Regression Based Multiple Imputation Method] [ Time Frame: Baseline to 18 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 114
Study Start Date: April 2006
Study Completion Date: November 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00277355

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

Additional Information:
Publications:
Responsible Party: Merit Cudkowicz, Principal Investigator, Huntington Study Group
ClinicalTrials.gov Identifier: NCT00277355     History of Changes
Other Study ID Numbers: FD-R-002588, DOMINO
Study First Received: January 12, 2006
Results First Received: March 7, 2013
Last Updated: April 17, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by 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
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014