Pilot Study of Minocycline in Huntington's Disease

Merit Cudkowicz

Status and phase: Completed; Phase 3; Phase 2

Conditions: Huntington Disease

Treatments: Drug: Matching placebo; Drug: minocycline

Study type: Interventional

Funder types: NETWORK; Other U.S. Federal agency

Identifiers

NCT00277355

FD-R-002588

DOMINO

Details and patient eligibility

About

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.

Full 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.

Enrollment: 114 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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114 participants in 2 patient groups, including a placebo group

Minocycline

Experimental group

Description:

Minocycline (3:1 randomization) 100 mg capsules taken by mouth twice daily, 200 mg per day total for 18 months treatment duration.

Treatment:

Drug: minocycline

Matching placebo

Placebo Comparator group

Description:

Sugar pill manufactured to mimic minocycline, 1 capsule taken by mouth twice daily for 18 months treatment duration.

Treatment:

Drug: Matching placebo