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NCT01747915 · ClinicalTrials.gov registry record · Phase 3
A Safety, Efficacy and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric and Adult Subjects With Primary Generalized Tonic-Clonic (i.e., Grand Mal) Seizures.
A Phase 3 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- Completed
- Registry status
- Phase 3
- Development phase
- 219
- Enrollment target
NCT01747915: Completed Phase 3 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
NCT01747915 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 219 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01747915, 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
- 219 participants
- Enrollment target
Study Summary
The study is designed to evaluate the safety, tolerability and efficacy of two doses of pregabalin as add-on treatment in pediatric and adult subjects with Primary Generalized Tonic-Clonic (PGTC) seizures as compared to placebo. It is hypothesized that both doses of pregabalin will demonstrated superior efficacy when compared to placebo by reducing PGTC seizure frequency and that pregabalin will be safe and well tolerated.
Primary Outcome
All PGTC seizures experienced during treatment phase were recorded by the participants or their parents/legal guardian in a daily seizure diary. 28-day seizure rate for all PGTC seizures= (\[number of seizures in the double blind treatment phase\] divided by \[number of days in double blind treatment phase minus {-} number of missing diary days in treatment phase\])\*28. For log-transformation, the quantity 1 was added to the 28-day seizure rate for all participants to account for any possible "
Interventions
- DRUG Placebo
- DRUG Pregabalin Dose Level 1
- DRUG Pregabalin Dose Level 2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 219 participants |
| Start Date | 2013-04-03 |
| Est. Completion | 2019-02-20 |
| Phase | Phase 3 |
What the finished NCT01747915 record still lists
NCT01747915 is an interventional study that assigns participants to a tested intervention. The registered 219 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01747915 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01747915 about?
NCT01747915 is a clinical study titled "A Safety, Efficacy and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric and Adult Subjects With Primary Generalized Tonic-Clonic (i.e., Grand Mal) Seizures.". The study is designed to evaluate the safety, tolerability and efficacy of two doses of pregabalin as add-on treatment in pediatric and adult subjects with Primary Generalized Tonic-Clonic (PGTC) seizures as compared to placebo. It is hypothesized that both doses of pregabalin will demonstrated supe...
What is the current status of trial NCT01747915?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 219 participants. The study started on 2013-04-03. Estimated completion is 2019-02-20.
What interventions are being tested in trial NCT01747915?
The interventions under investigation include: Placebo (DRUG), Pregabalin Dose Level 1 (DRUG), Pregabalin Dose Level 2 (DRUG).
Who is sponsoring clinical trial NCT01747915?
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01747915's enrollment target sits among peer trials
219 1329th of 2000 higher than 670 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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