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NCT00524030 · ClinicalTrials.gov registry record · Phase 3
Efficacy And Safety Study Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures
A Phase 3 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- Terminated
- Registry status
- Phase 3
- Development phase
- 161
- Enrollment target
NCT00524030: Clinical Trial Phase 3 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
NCT00524030 is a Phase 3 study that was terminated before completion, run by Pfizer's Upjohn has merged with Mylan to form Viatris. The registered enrollment target is 161 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00524030, a Phase 3 study, was terminated before completion, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 161 participants
- Enrollment target
Study Summary
This study will determine the safety and efficacy of pregabalin (Lyrica) when administered by itself (without any other anti-epileptic medication) to epilepsy subjects for the treatment of partial seizures. The duration of the trial is about 6 months.
Primary Outcome
Participants who discontinued due to: episode of status epilepticus (SE); secondarily generalized tonic-clonic (SGTC) seizure if none within 2 years of study entry; 28-day study seizure rate during double-blind phase (DBP) greater than (\>)2 times maximum (Max) 28-day study seizure rate during baseline phase (BLP); 2-day study seizure rate during DBP \>2 times Max 2-day study seizure rate during BLP; or unacceptable clinically significant increase in frequency/intensity of seizure activity. Dete
Interventions
- DRUG pregabalin 600 mg/day
- DRUG pregabalin 150 mg/day
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 161 participants |
| Start Date | 2007-09 |
| Est. Completion | 2011-06 |
| Phase | Phase 3 |
Why NCT00524030 stopped before completion
NCT00524030 is an interventional study that assigns participants to a tested intervention. The registered 161 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 (79% lower).
The record links to 0 conditions, and to 2 interventions - of which pregabalin 600 mg/day is the first listed.
NCT00524030 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00524030 about?
NCT00524030 is a clinical study titled "Efficacy And Safety Study Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures". This study will determine the safety and efficacy of pregabalin (Lyrica) when administered by itself (without any other anti-epileptic medication) to epilepsy subjects for the treatment of partial seizures. The duration of the trial is about 6 months.
What is the current status of trial NCT00524030?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 161 participants. The study started on 2007-09. Estimated completion is 2011-06.
What interventions are being tested in trial NCT00524030?
The interventions under investigation include: pregabalin 600 mg/day (DRUG), pregabalin 150 mg/day (DRUG).
Who is sponsoring clinical trial NCT00524030?
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 NCT00524030's enrollment target sits among peer trials
161 1478th of 2000 higher than 522 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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