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NCT02072824 · ClinicalTrials.gov registry record · Phase 3
A Safety, Efficacy, and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric Subjects <4 Years of Age With Partial Onset Seizures.
A Phase 3 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- Completed
- Registry status
- Phase 3
- Development phase
- 175
- Enrollment target
NCT02072824 is a Phase 3 study that has completed, run by Pfizer's Upjohn has merged with Mylan to form Viatris. The registered enrollment target is 175 participants.
The verdict
NCT02072824, a Phase 3 study, has completed, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 175 participants
- Enrollment target
Study Summary
This study is designed to evaluate the effectiveness of 2 doses of pregabalin to reduce seizure frequency as an add on therapy in pediatric subjects 1 month to \<4 years of age with refractory partial onset seizures. It is hypothesized that both doses of pregabalin will demonstrate superior efficacy when compared to placebo by reducing the partial onset seizure frequency and that pregabalin will be safe and well tolerated.
Interventions
- DRUG Placebo
- DRUG Pregabalin Dose Level 1
- DRUG Pregabalin Dose Level 2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 175 participants |
| Start Date | 2014-09-16 |
| Est. Completion | 2018-03-13 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02072824
The ClinicalTrials.gov registry entry for NCT02072824 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 175 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer's Upjohn has merged with Mylan to form Viatris, which has 158 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02072824 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02072824 about?
NCT02072824 is a clinical study titled "A Safety, Efficacy, and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric Subjects <4 Years of Age With Partial Onset Seizures.". This study is designed to evaluate the effectiveness of 2 doses of pregabalin to reduce seizure frequency as an add on therapy in pediatric subjects 1 month to \<4 years of age with refractory partial onset seizures. It is hypothesized that both doses of pregabalin will demonstrate superior efficacy...
What is the current status of trial NCT02072824?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 175 participants. The study started on 2014-09-16. Estimated completion is 2018-03-13.
What interventions are being tested in trial NCT02072824?
The interventions under investigation include: Placebo (DRUG), Pregabalin Dose Level 1 (DRUG), Pregabalin Dose Level 2 (DRUG).
Who is sponsoring clinical trial NCT02072824?
This trial is sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris, which has 158 total clinical trials registered on ClinicalTrials.gov.
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