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NCT01405053 · ClinicalTrials.gov registry record · Phase 3
Study of Rufinamide in Pediatric Subjects 1 to Less Than 4 Years of Age With Lennox-Gastaut Syndrome Inadequately Controlled With Other Anti-epileptic Drugs
A Phase 3 study, sponsored by Eisai.
- Completed
- Registry status
- Phase 3
- Development phase
- 37
- Enrollment target
NCT01405053 is a Phase 3 study that has completed, run by Eisai. The registered enrollment target is 37 participants.
The verdict
NCT01405053, a Phase 3 study, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 37 participants
- Enrollment target
Study Summary
This study was designed to evaluate the cognitive effect, safety, and pharmacokinetics (PK) of rufinamide on Lennox-Gastaut Syndrome (LGS) inadequately controlled in pediatric participants already taking other anti-epileptic drugs.
Interventions
- DRUG Rufinamide
- DRUG Any other approved Antiepileptic Drug
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2011-06-16 |
| Est. Completion | 2015-11-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01405053
The ClinicalTrials.gov registry entry for NCT01405053 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eisai, which has 287 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Rufinamide is the first listed.
NCT01405053 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01405053 about?
NCT01405053 is a clinical study titled "Study of Rufinamide in Pediatric Subjects 1 to Less Than 4 Years of Age With Lennox-Gastaut Syndrome Inadequately Controlled With Other Anti-epileptic Drugs". This study was designed to evaluate the cognitive effect, safety, and pharmacokinetics (PK) of rufinamide on Lennox-Gastaut Syndrome (LGS) inadequately controlled in pediatric participants already taking other anti-epileptic drugs.
What is the current status of trial NCT01405053?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 37 participants. The study started on 2011-06-16. Estimated completion is 2015-11-02.
What interventions are being tested in trial NCT01405053?
The interventions under investigation include: Rufinamide (DRUG), Any other approved Antiepileptic Drug (DRUG).
Who is sponsoring clinical trial NCT01405053?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
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