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NCT00319501 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Diazepam in the Management of Refractory Epilepsy in Selected Patients Who Require Intermittent Medical Intervention for Acute Repetitive Seizures.
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 234
- Enrollment target
NCT00319501: Completed Phase 3 study, sponsored by Pfizer.
NCT00319501 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 234 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00319501, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 234 participants
- Enrollment target
Study Summary
To evaluate the efficacy and safety of diazepam in the management of refractory epilepsy in selected patients who require intermittent medical intervention for the control of episodes of acute repetitive seizures. In addition, to assess the support provided by caregivers who are not themselves or not under the direct supervision of health care professionals at the time of administration.
Primary Outcome
An event was defined as an episode of or required rescue medication for an episode of acute repetitive seizures (ARS) within 15 minutes to 12 hours following study drug administration. Patients without an ARS event were censored at 12 hours. Diaries were provided; if no diary was returned, or the diary did not provide answers to questions about seizures and rescue during the 12-hour follow-up period, the patient was considered censored as of 15 minutes past the treatment time, unless another con
Interventions
- DRUG Placebo
- DRUG Vanquix Auto-Injector (Diazepam Injection)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 234 participants |
| Start Date | 2006-01 |
| Est. Completion | 2014-07 |
| Phase | Phase 3 |
What the finished NCT00319501 record still lists
NCT00319501 is an interventional study that assigns participants to a tested intervention. The registered 234 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 (70% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00319501 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00319501 about?
NCT00319501 is a clinical study titled "Efficacy and Safety of Diazepam in the Management of Refractory Epilepsy in Selected Patients Who Require Intermittent Medical Intervention for Acute Repetitive Seizures.". To evaluate the efficacy and safety of diazepam in the management of refractory epilepsy in selected patients who require intermittent medical intervention for the control of episodes of acute repetitive seizures. In addition, to assess the support provided by caregivers who are not themselves or no...
What is the current status of trial NCT00319501?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 234 participants. The study started on 2006-01. Estimated completion is 2014-07.
What interventions are being tested in trial NCT00319501?
The interventions under investigation include: Placebo (DRUG), Vanquix Auto-Injector (Diazepam Injection) (DRUG).
Who is sponsoring clinical trial NCT00319501?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00319501's enrollment target sits among peer trials
234 1297th of 2000 higher than 703 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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