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NCT03436433 · ClinicalTrials.gov registry record · Phase 2
Seizure Prophylaxis in Patients With Glioma or Brain Metastasis
A Phase 2 study, sponsored by Duke University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 4
- Enrollment target
NCT03436433 is a Phase 2 study that was terminated before completion, run by Duke University. The registered enrollment target is 4 participants.
The verdict
NCT03436433, a Phase 2 study, was terminated before completion, sponsored by Duke University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 4 participants
- Enrollment target
Study Summary
This protocol is designed to assess the need for seizure prophylaxis in the perioperative period for patients undergoing neurosurgical procedure (gross-total resection, sub-total resection or biopsy) for suspected diagnosis of new, recurrent or transformed glioma (WHO grade I-IV) and brain metastasis. This will be determined by observing the impact of Lacosamide (LCM), Levetiracetam (LEV), or no anti-epileptic drug (AED) on whether visits to the emergency department (ED) or hospital re-admissions occur within 30 days after procedure. A secondary endpoint will evaluate the safety and tolerability of LCM and LEV. Exploratory endpoints will evaluate admission duration for the procedure, number of post-operative provider communications (telephone, email, and additional clinic encounters, etc.), and patient risk factors associated with post-operative seizure.
Interventions
- DRUG Levetiracetam
- DRUG Lacosamide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2019-01-31 |
| Est. Completion | 2020-12-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03436433
The ClinicalTrials.gov registry entry for NCT03436433 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Levetiracetam is the first listed.
NCT03436433 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03436433 about?
NCT03436433 is a clinical study titled "Seizure Prophylaxis in Patients With Glioma or Brain Metastasis". This protocol is designed to assess the need for seizure prophylaxis in the perioperative period for patients undergoing neurosurgical procedure (gross-total resection, sub-total resection or biopsy) for suspected diagnosis of new, recurrent or transformed glioma (WHO grade I-IV) and brain metastasi...
What is the current status of trial NCT03436433?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 4 participants. The study started on 2019-01-31. Estimated completion is 2020-12-04.
What interventions are being tested in trial NCT03436433?
The interventions under investigation include: Levetiracetam (DRUG), Lacosamide (DRUG).
Who is sponsoring clinical trial NCT03436433?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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