Pilot Study of Minocycline in Huntington's Disease
This study has been completed.
Sponsor:
Merit Cudkowicz
Collaborator:
FDA Office of Orphan Products Development
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
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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 (Adult, Senior) |
| 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
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
FDA Office of Orphan Products Development
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 Neurocognitive Disorders Mental Disorders Minocycline Anti-Bacterial Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on September 23, 2016