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

Stopped early · Phase 2

Conditions studied: Huntington's Disease

In brief

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

Key facts

Study ID

NCT02342548

Run by

Pfizer

People needed

188

Starts

2015-02-25

Expected to finish

2017-02-06

Last updated by the study team

2018-04-23

Who can join

Age: 30 and older, up to 66. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must have completed study A8241021
• Diagnosis of HD, including ≥36 CAG repeats.

You may not qualify if…

• Significant neurological disorder other than Huntington's disease.
• WBC ≤ 3500/mm3 AND/OR ANC ≤ 2000/mm3 and history of neutropenia or myeolo-proliferative disorders.
• Any drug related SAE experienced during study A8241021 which were not approved as acceptable for enrollment in A8241022.

Where it is running

• The Kirkland Clinic of UAB Hospital — Birmingham, Alabama, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Mayo Clinic Arizona — Scottsdale, Arizona, United States
• University of California, Irvine — Irvine, California, United States
• Ronald Reagan 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 & Neurorestoration — Gainesville, Florida, United States
• Indiana University Health Neuroscience Center — Indianapolis, Indiana, 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 — Winston-Salem, North Carolina, United States
• The Ohio State University — Columbus, Ohio, United States
• The Wexner Medical Center at the Ohio State University — Columbus, Ohio, United States
• The Wright Center of Innovation- The Ohio State University — Columbus, Ohio, United States
• Baylor College of Medicine — Houston, Texas, United States
• The Centre For Huntington Disease, The University of British Columbia — Vancouver, British Columbia, Canada
• Center For Movement Disorders — Toronto, Ontario, Canada
• CHUM-Notre-Dame Hospital — Montreal, Quebec, Canada
• CHUM-Notre-Dame, Pharmacie — Montreal, Quebec, Canada
• Uniklinik RWTH Aachen — Aachen, Germany
• Charité - Universitätsmedizin Berlin — Berlin, Germany
• St. Josef Hospital — Bochum, Germany
• Friedrich-Alexander-Universität — Erlangen, Germany

Full record on ClinicalTrials.gov

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