Phase 3 N=114 Randomized Double-blind Treatment

Pilot Study of Minocycline in Huntington's Disease

Huntington Disease

Bottom Line

View on ClinicalTrials.gov: NCT00277355 ↗

Enrolled (actual)

114

Serious AEs

10.5%

Results posted

Apr 2013

Primary outcome: Primary: Change From Baseline to Month 18 in the Total Functional Capacity (TFC) Scale [LOCF Imputation Method] — 1.55; 1.15 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: minocycline (Drug); Matching placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Merit Cudkowicz
Primary completion: Oct 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline to Month 18 in the Total Functional Capacity (TFC) Scale [LOCF Imputation Method]	1.55; 1.15	—
SECONDARY Change From Baseline to Month 18 in the Total Functional Capacity (TFC) Scale [Regression Based Multiple Imputation Method]	1.71; 1.15	—

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.

Eligibility Criteria

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00277355). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.