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NCT Number: NCT00277355

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.

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Key information

Conditions

Huntington Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Chorea Cognition Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dementia Dyskinesias Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Mental Disorders Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of British Columbia, Vancouver, British Columbia, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Minocycline

Drug

Minocycline: Oral; minocycline 100 mg capsules administered twice a day with the morning and evening meal (~ 8 hours apart)

Matching Placebo

Drug

Matching placebo 1 capsule twice daily, 18 months treatment duration.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Merit Cudkowicz

Network

Collaborators

  • FDA Office of Orphan Products Development

Registry information

Official study title

A Multi-Center, Double-Blind, Pilot Study of Minocycline in Huntington's Disease

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jan 16, 2006
Registry last updated
Apr 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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