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

Completed · Phase 2 · Has a placebo group

Conditions studied: Huntington's Disease

In brief

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.

Key facts

Study ID

NCT02197130

Run by

Pfizer

People needed

272

Starts

2014-09-01

Expected to finish

2016-10-01

Last updated by the study team

2017-11-17

Who can join

Age: 30 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• CAG repeat equal or greater than 36;
• Total motor score equal or greater than 10;
• Total functional capacity equal or greater than 7.

You may not qualify if…

• Clinically significant neurologic disorder other than Huntington's disease;
• Other severe acute psychiatric conditions, mania and/or psychosis;
• History of neutropenia, and myeloproliferative disorders;

Where it is running

• The University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Mayo Clinic Arizona — Phoenix, Arizona, United States
• Mayo Clinic Arizona — Scottsdale, Arizona, United States
• University of California, Irvine — Irvine, California, United States
• Ronald Regan UCLA Medical Center Drug Information Center — Los Angeles, California, United States
• UCLA Neurology Clinic — Los Angeles, California, United States
• UCLA Radiology — Los Angeles, California, United States
• Rocky Mountain Movement Disorders Center — Englewood, Colorado, United States
• University of Florida Center for Movement Disorders and Neurorestoration — Gainesville, Florida, United States
• Indiana University Health Neuroscience Center — Indianapolis, Indiana, United States
• Massachusetts General Hospital — Charlestown, Massachusetts, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Albany Medical College — Albany, New York, United States
• Wake Forest Baptist Medical Center - Dept. of Neurology — Winston-Salem, North Carolina, United States
• Cleveland Clinic Foundation Hospital Pharmacy — Cleveland, Ohio, United States
• The Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Davis Medical Center — Columbus, Ohio, United States
• The Wexner Medical Center at the Ohio State University — Columbus, Ohio, United States
• Wexner Medical Center at the Ohio State University — Columbus, Ohio, United States
• Baylor College of Medicine — Houston, Texas, United States
• The Centre for Huntington Disease — Vancouver, British Columbia, Canada
• Centre for Movement Disorders — Toronto, Ontario, Canada
• CHUM-Notre-Dame Hospital — Montreal, Quebec, Canada
• The Kirklin Clinic of UAB Hospital — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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