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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
Sponsor:
Collaborator:
FDA Office of Orphan Products Development
Information provided by (Responsible Party):
Merit Cudkowicz, Huntington Study Group

Tracking Information
First Submitted Date  ICMJE January 12, 2006
First Posted Date  ICMJE January 16, 2006
Results First Submitted Date  ICMJE March 7, 2013
Results First Posted Date  ICMJE April 19, 2013
Last Update Posted Date April 19, 2013
Study Start Date  ICMJE April 2006
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2013)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: January 12, 2006)
Establish preliminary estimate of minocycline's impact on progression of HD (measured by the change in TFC score of UHDRS'99 between baseline & Month 18), and to assess futility of further study of the agent.
Change History Complete list of historical versions of study NCT00277355 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2013)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2006)
To collect additional data on safety/tolerability to plan future efficacy trial of minocycline.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilot Study of Minocycline in Huntington's Disease
Official Title  ICMJE A Multi-Center, Double-Blind, Pilot Study of Minocycline in Huntington's Disease
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Huntington Disease
Intervention  ICMJE
  • Drug: minocycline
    Minocycline: Oral; minocycline 100 mg capsules administered twice a day with the morning and evening meal (~ 8 hours apart)
  • Drug: Matching placebo
    Matching placebo 1 capsule twice daily, 18 months treatment duration.
Study Arms  ICMJE
  • Experimental: Minocycline
    Minocycline (3:1 randomization) 100 mg capsules taken by mouth twice daily, 200 mg per day total for 18 months treatment duration.
    Intervention: Drug: minocycline
  • Placebo Comparator: Matching placebo
    Sugar pill manufactured to mimic minocycline, 1 capsule taken by mouth twice daily for 18 months treatment duration.
    Intervention: Drug: Matching placebo
Publications * Huntington Study Group. Minocycline safety and tolerability in Huntington disease. Neurology. 2004 Aug 10;63(3):547-9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 31, 2007)
114
Original Enrollment  ICMJE
 (submitted: January 12, 2006)
100
Actual Study Completion Date  ICMJE November 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00277355
Other Study ID Numbers  ICMJE FD-R-002588
DOMINO
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merit Cudkowicz, Huntington Study Group
Study Sponsor  ICMJE Merit Cudkowicz
Collaborators  ICMJE FDA Office of Orphan Products Development
Investigators  ICMJE
Principal Investigator: Merit E. Cudkowicz, MD Massachusetts General Hospital
PRS Account Huntington Study Group
Verification Date April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP