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NCT02342548 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study, sponsored by Pfizer.
- Terminated
- Registry status
- Phase 2
- Development phase
- 188
- Enrollment target
NCT02342548: Clinical Trial Phase 2 study, sponsored by Pfizer.
NCT02342548 is a Phase 2 study that was terminated before completion, run by Pfizer. The registered enrollment target is 188 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02342548, a Phase 2 study, was terminated before completion, sponsored by Pfizer.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 188 participants
- Enrollment target
Study 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
Primary Outcome
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of its causal relationship with study treatment. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; was life-threatening (immediate risk of death); persistent or significant disability/incapacity; congenital anomaly. Tre
Interventions
- DRUG 20 mg BID of PF-02545920
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 188 participants |
| Start Date | 2015-02-25 |
| Est. Completion | 2017-02-06 |
| Phase | Phase 2 |
Why NCT02342548 stopped before completion
NCT02342548 is an interventional study that assigns participants to a tested intervention. The registered 188 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% higher).
The record links to 0 conditions, and to 1 intervention - of which 20 mg BID of PF-02545920 is the first listed.
NCT02342548 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02342548 about?
NCT02342548 is a clinical study titled "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". 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 ...
What is the current status of trial NCT02342548?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 188 participants. The study started on 2015-02-25. Estimated completion is 2017-02-06.
What interventions are being tested in trial NCT02342548?
The interventions under investigation include: 20 mg BID of PF-02545920 (DRUG).
Who is sponsoring clinical trial NCT02342548?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02342548's enrollment target sits among peer trials
188 356th of 2000 higher than 1,644 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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