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NCT01284530 · ClinicalTrials.gov registry record · Phase 1
Evaluation of the Pharmacokinetics, Safety, and Tolerability of TPM XR as Adjunctive Therapy in Pediatric Subjects With Epilepsy
A Phase 1 study, sponsored by Supernus Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT01284530: Completed Phase 1 study, sponsored by Supernus Pharmaceuticals.
NCT01284530 is a Phase 1 study that has completed, run by Supernus Pharmaceuticals. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01284530, a Phase 1 study, has completed, sponsored by Supernus Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
Multidose, Open-label, Multi-center Study to examine the steady state pharmacokinetics of TPM XR, as well as, safety and tolerability of repeated oral dosing in pediatric subjects with epilepsy.
Primary Outcome
Relating to repeated oral dosing
Interventions
- DRUG TPM XR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2011-01 |
| Est. Completion | 2012-06 |
| Phase | Phase 1 |
What the finished NCT01284530 record still lists
NCT01284530 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 1 intervention - of which TPM XR is the first listed.
NCT01284530 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01284530 about?
NCT01284530 is a clinical study titled "Evaluation of the Pharmacokinetics, Safety, and Tolerability of TPM XR as Adjunctive Therapy in Pediatric Subjects With Epilepsy". Multidose, Open-label, Multi-center Study to examine the steady state pharmacokinetics of TPM XR, as well as, safety and tolerability of repeated oral dosing in pediatric subjects with epilepsy.
What is the current status of trial NCT01284530?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2011-01. Estimated completion is 2012-06.
What interventions are being tested in trial NCT01284530?
The interventions under investigation include: TPM XR (DRUG).
Who is sponsoring clinical trial NCT01284530?
This trial is sponsored by Supernus Pharmaceuticals, which has 57 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01284530's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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