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NCT01494584 · ClinicalTrials.gov registry record · Phase 2
Study in Pediatric Subjects With Epilepsy
A Phase 2 study, sponsored by GlaxoSmithKline.
- Terminated
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
NCT01494584: Clinical Trial Phase 2 study, sponsored by GlaxoSmithKline.
NCT01494584 is a Phase 2 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 5 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01494584, a Phase 2 study, was terminated before completion, sponsored by GlaxoSmithKline.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
Study Summary
This is an open-label study to evaluate the pharmacokinetics, safety and tolerability of ezogabine/retigabine in subjects aged 12 years to less than 18 years with uncontrolled partial onset seizures or Lennos-Gastaut syndrome.
Primary Outcome
The steady state pharmacokinetic profile following oral administration of ezogabine/retigabine included determining the area under the curve over the dosing interval (AUC\[0-tau\]). The area under the plasma concentration-time curve over the dosing interval (AUC\[0-tau\]) was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. Blood samples were collected at pre-dose and at 0.5, 1, 1.5, 2, 4, 6, and 8 hour
Interventions
- DRUG ezogabine/retigabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2012-07-25 |
| Est. Completion | 2013-04-29 |
| Phase | Phase 2 |
Why NCT01494584 stopped before completion
NCT01494584 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which ezogabine/retigabine is the first listed.
NCT01494584 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01494584 about?
NCT01494584 is a clinical study titled "Study in Pediatric Subjects With Epilepsy". This is an open-label study to evaluate the pharmacokinetics, safety and tolerability of ezogabine/retigabine in subjects aged 12 years to less than 18 years with uncontrolled partial onset seizures or Lennos-Gastaut syndrome.
What is the current status of trial NCT01494584?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2012-07-25. Estimated completion is 2013-04-29.
What interventions are being tested in trial NCT01494584?
The interventions under investigation include: ezogabine/retigabine (DRUG).
Who is sponsoring clinical trial NCT01494584?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01494584's enrollment target sits among peer trials
5 2000th of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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