drugset / Trial / NCT02197130

Randomized, Placebo Controlled Study Of The Efficacy And Safety Of PF-02545920 In Subjects With Huntington's Disease

NCT02197130

Phase 2 Completed 272 enrolled Pfizer
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is a 26 week, randomized, parallel group, double blind comparison of PF-02545920 5 mg, PF-02545920 20 mg, and placebo dosed BID in the treatment of motor impairment of subjects with Huntington's Disease. A total of approximately 260 subjects are planned to be randomized in the study. Primary endpoint is the change from baseline in the Total Motor Score (TMS) assessment of the Unified Huntington Disease Rating Scale (UHDRS) after 26 weeks of treatment. secondary endpoints will include change from baseline in the Total Maximum Chorea (TMC) score of the UHDRS after 13 and 26 weeks of treatment and Clinical Global Impression-Improvement score after 13 and 26 weeks of treatment.

Timeline

Start
2014-09
Primary completion
2016-09
Completion
2016-10

Drugs

EvaluationDrugModalityDoseRoute
Subject MARDEPODECT Small molecule 5 mg
Subject MARDEPODECT Small molecule 20 mg

Indications