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Pilot Study of Minocycline in Huntington's Disease

This study has been completed.
Sponsor:
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
History of Changes

January 12, 2006
April 17, 2013
April 2006
October 2008   (final data collection date for primary outcome measure)
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).
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.
Complete list of historical versions of study NCT00277355 on ClinicalTrials.gov Archive Site
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.
To collect additional data on safety/tolerability to plan future efficacy trial of minocycline.
Not Provided
Not Provided
 
Pilot Study of Minocycline in Huntington's Disease
A Multi-Center, Double-Blind, Pilot Study of Minocycline in Huntington's Disease

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.

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.
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Huntington Disease
  • 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.
  • 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
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.
 
Completed
114
November 2008
October 2008   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00277355
FD-R-002588, DOMINO
Yes
Merit Cudkowicz, Huntington Study Group
Merit Cudkowicz
FDA Office of Orphan Products Development
Principal Investigator: Merit E. Cudkowicz, MD Massachusetts General Hospital
Huntington Study Group
April 2013

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