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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: Completed Phase 3 study, sponsored by Eisai.
NCT01405053 is a Phase 3 study that has completed, run by Eisai. The registered enrollment target is 37 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
CBCL: 99-item questionnaire measures specific behavioral problems or developmental delays, answered by a parent/legal guardian or suitable caregiver. Each item were rated using 3-point scale (0=Not True, 1=Somewhat/Sometimes True, 2=Very True/ Often True) to indicate how often or typical the behavior was. The 99 items were combined to yield scores for 8 problem area scales (emotionally reactive, anxious/depressed, somatic complaints, withdrawn, sleep problems, attention problems, aggressive beha
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 |
What the finished NCT01405053 record still lists
NCT01405053 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Rufinamide is the first listed.
NCT01405053 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01405053's enrollment target sits among peer trials
37 1901st of 2000 higher than 100 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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