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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 is a Phase 2 study that was terminated before completion, run by Pfizer. The registered enrollment target is 188 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02342548
The ClinicalTrials.gov registry entry for NCT02342548 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 188 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which 20 mg BID of PF-02545920 is the first listed.
NCT02342548 reports 0 study locations.
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.
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