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NCT00351611 · ClinicalTrials.gov registry record · Phase 4
Vision Testing in Patients With Partial Seizures Receiving Either Lyrica or Placebo
A Phase 4 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- Completed
- Registry status
- Phase 4
- Development phase
- 187
- Enrollment target
NCT00351611: Completed Phase 4 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
NCT00351611 is a Phase 4 study that has completed, run by Pfizer's Upjohn has merged with Mylan to form Viatris. The registered enrollment target is 187 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00351611, a Phase 4 study, has completed, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 187 participants
- Enrollment target
Study Summary
Patients with partial seizures currently taking 1-3 antiepileptic medications will have a 50:50 chance to receive Lyrica 300 mg per day or placebo (no active ingredients) added on to their current medications for 3 months. Neither the study doctor nor the patient will know the medication assignment. Vision testing will be performed prior to receiving the study treatment and at the end of the study to see if there are any changes.
Primary Outcome
In this primary outcome measure, percentage of participants is reported, with a decrease in the threshold value from baseline to Week 12 or termination in any 5 or more points (in either eye) at the p\<0.05 level repeated in the same 5 points on subsequent computerized automated perimetry testing (Humphrey 24-2 SITA standard). It was derived from the Humphrey 24-2 SITA standard visual field analyzer. For each eye there were 52 test points. For each test point, the Humphrey analyzer determined th
Interventions
- DRUG placebo
- DRUG Lyrica (pregabalin)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 187 participants |
| Start Date | 2006-07-26 |
| Est. Completion | 2020-02-04 |
| Phase | Phase 4 |
What the finished NCT00351611 record still lists
NCT00351611 is an interventional study that assigns participants to a tested intervention. The registered 187 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (64% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00351611 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00351611 about?
NCT00351611 is a clinical study titled "Vision Testing in Patients With Partial Seizures Receiving Either Lyrica or Placebo". Patients with partial seizures currently taking 1-3 antiepileptic medications will have a 50:50 chance to receive Lyrica 300 mg per day or placebo (no active ingredients) added on to their current medications for 3 months. Neither the study doctor nor the patient will know the medication assignment....
What is the current status of trial NCT00351611?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 187 participants. The study started on 2006-07-26. Estimated completion is 2020-02-04.
What interventions are being tested in trial NCT00351611?
The interventions under investigation include: placebo (DRUG), Lyrica (pregabalin) (DRUG).
Who is sponsoring clinical trial NCT00351611?
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 NCT00351611's enrollment target sits among peer trials
187 459th of 2000 higher than 1,542 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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