NCT02342548

Open Label Extension Study To Investigate Long Term Safety, Tolerability And Efficacy Of Pf-02545920 In Subjects With Huntington's Disease Who Completed Study A8241021

An Open Label Extension Study To Investigate The Long Term Safety, Tolerability And Efficacy Of Pf-02545920 In Subjects With Huntington's Disease Who Previously Completed Study A8241021

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 188 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 30 Years – 66 Years
• Healthy volunteers: Not accepted

Summary

This study is a 12 month open label extension study of PF-02545920 20 mg dosed BID following study A8241021 in subjects with HD. Primary endpoints will be to assess long-term safety and tolerability of 20 mg BID of PF-02545920. Secondary endpoints will be the change from baseline in the Total Motor Score (TMS)assessment, and/ior the Total maximum Chorea (TMC) assessment of the Unified Huntington Disease Rating Scale (UHDRS) after 6 and 12 months of treatment, and Clinical Global Impression-Improvement score after 6 and 12 months of treatment. Subjects, who were assigned to the 20 mg PF-02545920 dose group in the preceding A8241021 study, will receive 20 mg PF-02545920 without any titration. All other subjects will be titrated to the 20 mg BID dose as follows: 5 mg BID for 7 days, 10 mg BID for 7 days, 15 mg BID for 7 days, then 20 mg BID for the remainder of the treatment phase. Up to 260 subjects may take part in this open label extension

Conditions

• Huntington's Disease

Interventions

Type	Name	Description
DRUG	20 mg BID of PF-02545920	All subject who completed A8241021 will receive 20 mg BID (with or without titration)

Timeline

• Start date: 2015-02-25
• Primary completion: 2017-02-06
• Completion: 2017-02-06
• First posted: 2015-01-21
• Last updated: 2018-04-23
• Results posted: 2018-04-23

Locations

50 sites across 5 countries: United States, Canada, Germany, Poland, United Kingdom