Pilot Study of Minocycline in Huntington's Disease
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ClinicalTrials.gov Identifier: NCT00277355 |
Recruitment Status
:
Completed
First Posted
: January 16, 2006
Results First Posted
: April 19, 2013
Last Update Posted
: April 19, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Huntington Disease | Drug: minocycline Drug: Matching placebo | Phase 2 Phase 3 |
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 |

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

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00277355
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 |
Principal Investigator: | Merit E. Cudkowicz, MD | Massachusetts General Hospital |
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 |
First Posted: | January 16, 2006 Key Record Dates |
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 |