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NCT02197130 · ClinicalTrials.gov registry record · Phase 2
Randomized, Placebo Controlled Study Of The Efficacy And Safety Of PF-02545920 In Subjects With Huntington's Disease
A Phase 2 study of Huntington's Disease, sponsored by Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 272
- Enrollment target
- 20
- Study locations
NCT02197130: Completed Phase 2 study of Huntington's Disease, sponsored by Pfizer.
NCT02197130 is a Phase 2 study of Huntington's Disease that has completed, run by Pfizer. The registered enrollment target is 272 participants, below the 4,760-participant average among 8 other Huntington's Disease trials with a reported enrollment target (94% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02197130, a Phase 2 study of Huntington's Disease, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 272 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
The UHDRS was a clinical rating scale which has been developed by the Huntington Disease Study Group (HSG) to provide a uniform assessment of the clinical features and course of Huntington's Disease (HD). The components of the full UHDRS assess motor function, cognition, behavior and functional abilities. The total motor score (TMS) assessed motor features of HD with standardized ratings of oculomotor function, dysarthria, chorea, dystonia, gait, and postural stability. Some items (such as chore
Conditions Studied
Interventions
- OTHER Placebo
- DRUG PF-02545920
Study Locations (20)
California
- University of California, Irvine - Irvine
- Ronald Regan UCLA Medical Center Drug Information Center - Los Angeles
- UCLA Neurology Clinic - Los Angeles
- UCLA Radiology - Los Angeles
Ohio
- Cleveland Clinic Foundation Hospital Pharmacy - Cleveland
- The Cleveland Clinic Foundation - Cleveland
- Davis Medical Center - Columbus
- The Wexner Medical Center at the Ohio State University - Columbus
Alabama
- The Kirklin Clinic of UAB Hospital - Birmingham
- The University of Alabama at Birmingham - Birmingham
- University of Alabama at Birmingham - Birmingham
Arizona
- Mayo Clinic Arizona - Phoenix
- Mayo Clinic Arizona - Scottsdale
Colorado
- Rocky Mountain Movement Disorders Center - Englewood
Florida
- University of Florida Center for Movement Disorders and Neurorestoration - Gainesville
Indiana
- Indiana University Health Neuroscience Center - Indianapolis
Massachusetts
- Massachusetts General Hospital - Charlestown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 272 participants |
| Start Date | 2014-09 |
| Est. Completion | 2016-10 |
| Phase | Phase 2 |
What the finished NCT02197130 record still lists
NCT02197130 is an interventional study that assigns participants to a tested intervention. The registered 272 participants enrollment target is mid-sized for trials with a published cap, below the 4,760-participant average among 8 other Huntington's Disease trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Huntington's Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02197130 names 20 study sites across 11 states, led by California, Ohio, Alabama.
Frequently Asked Questions
What is clinical trial NCT02197130 about?
NCT02197130 is a clinical study titled "Randomized, Placebo Controlled Study Of The Efficacy And Safety Of PF-02545920 In Subjects With Huntington's Disease". 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. Prim...
What is the current status of trial NCT02197130?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 272 participants. The study started on 2014-09. Estimated completion is 2016-10.
What conditions does trial NCT02197130 study?
This clinical trial studies the following conditions: Huntington's Disease.
What interventions are being tested in trial NCT02197130?
The interventions under investigation include: Placebo (OTHER), PF-02545920 (DRUG).
Who is sponsoring clinical trial NCT02197130?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02197130 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02197130's enrollment target sits among peer trials
272 4th of 8 higher than 5 of 8 other Huntington's Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Huntington's Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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