Pilot Study of Minocycline in Huntington's Disease
A Multi-Center, Double-Blind, Pilot Study of Minocycline in Huntington's Disease
2 other identifiers
interventional
114
2 countries
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2006
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 12, 2006
CompletedFirst Posted
Study publicly available on registry
January 16, 2006
CompletedStudy Start
First participant enrolled
April 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedResults Posted
Study results publicly available
April 19, 2013
CompletedApril 19, 2013
April 1, 2013
2.5 years
January 12, 2006
March 7, 2013
April 17, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Change From Baseline to Month 18 in the Total Functional Capacity (TFC) Scale [Regression Based Multiple Imputation Method]
Baseline to 18 months
Study Arms (2)
Minocycline
EXPERIMENTALMinocycline (3:1 randomization) 100 mg capsules taken by mouth twice daily, 200 mg per day total for 18 months treatment duration.
Matching placebo
PLACEBO COMPARATORSugar pill manufactured to mimic minocycline, 1 capsule taken by mouth twice daily for 18 months treatment duration.
Interventions
Minocycline: Oral; minocycline 100 mg capsules administered twice a day with the morning and evening meal (\~ 8 hours apart)
Matching placebo 1 capsule twice daily, 18 months treatment duration.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Merit Cudkowiczlead
- FDA Office of Orphan Products Developmentcollaborator
Study Sites (12)
University of Alabama at Birmingham
Birmingham, Alabama, United States
Colorado Neurological Institute
Englewood, Colorado, United States
University of Florida
Gainesville, Florida, United States
University of South Florida
Tampa, Florida, United States
University of Maryland School of Medicine
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
Albany Medical College
Albany, New York, United States
Columbia University
New York, New York, United States
University of Rochester
Rochester, New York, United States
University of Texas Medical Branch at Galveston
Galveston, Texas, United States
University of British Columbia
Vancouver, British Columbia, Canada
Related Publications (1)
Huntington Study Group. Minocycline safety and tolerability in Huntington disease. Neurology. 2004 Aug 10;63(3):547-9. doi: 10.1212/01.wnl.0000133403.30559.ff.
PMID: 15304592BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Merit Cudkowicz, MD, MSc
- Organization
- Massachusetts General Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Merit E. Cudkowicz, MD
Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 12, 2006
First Posted
January 16, 2006
Study Start
April 1, 2006
Primary Completion
October 1, 2008
Study Completion
November 1, 2008
Last Updated
April 19, 2013
Results First Posted
April 19, 2013
Record last verified: 2013-04