NCT00277355

Pilot Study of Minocycline in Huntington's Disease

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Merit Cudkowicz · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Huntington Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2006-04-01
• Primary completion: 2008-10-01
• Completion: 2008-11-01
• First posted: 2006-01-16
• Last updated: 2013-04-19
• Results posted: 2013-04-19

Locations

12 sites across 2 countries: United States, Canada