A8241021 - PF-02545920 IN SUBJECTS WITH HUNTINGTON’S DISEASE
Research type
Research Study
Full title
A Phase 2, Randomized, Placebo Controlled, Double-Blind, Proof-of-concept Study of the Efficacy and Safety of PF-02545920 in Subjects with Huntington’s disease
IRAS ID
156161
Contact name
David Craufurd
Contact email
Sponsor organisation
Pfizer Inc.
Eudract number
2014-001291-56
Clinicaltrials.gov Identifier
118,646, US IND
Research summary
Huntington's disease (HD) is a neurodegenerative genetic disorder that affects muscle coordination and leads to cognitive decline and psychiatric problems. It typically becomes noticeable in mid-adult life. The disease can affect both men and women. The disease is caused by an autosomal dominant mutation in either of an individual's two copies of a gene called Huntingtin, which means any child of an affected person typically has a 50% chance of inheriting the disease. HD is ultimately fatal, and there is currently no effective disease-modifying treatment.
The purpose of this research study is to compare the safety, tolerability and effectiveness of two doses of PF-02545920 to placebo on improving voluntary movement and overall symptoms in participants with Huntington’s disease.
There will be about 260 people enrolled in this study. The study is being done at about 40 different research sites in 5 countries.
This study is a randomised, parallel group, double blind comparison of PF-02545920 5 mg, PF-02545920 20 mg, and placebo. This means that neither the study doctor nor the participant know which treatment arm they are in. Depending on when the participant enters the study, the chance of receiving 20 mg PF-02545920 or placebo will be either 28.5 or 40%, and the chance to receive 5mg PF-02545920 will be either 20 or 43%.
Participants will be in this study for about 31 weeks. They will need to visit the research site at least 10 times during the study. Participants at selected sites will participate in the MRI sub-study. The MRI sub-study involves two MRI procedures, one at Visit 2 and one at Visit 9.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
14/YH/1112
Date of REC Opinion
9 Sep 2014
REC opinion
Further Information Favourable Opinion