Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02201251 · ClinicalTrials.gov registry record · Phase 3
A Study to Investigate the Safety of the Drugs Topiramate and Levetiracetam in Treating Children Recently Diagnosed With Epilepsy
A Phase 3 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 63
- Enrollment target
NCT02201251: Completed Phase 3 study, sponsored by Janssen Research & Development.
NCT02201251 is a Phase 3 study that has completed, run by Janssen Research & Development. The registered enrollment target is 63 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02201251, a Phase 3 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 63 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety of topiramate monotherapy compared with levetiracetam another standard antiepileptic drug (AED), as monotherapy for new-onset or recent-onset epilepsy (seizure disorder) on pediatric growth and maturation, bone mineralization, and kidney stone formation in children aged 2 to 15 years.
Primary Outcome
The Z-Score indicates how many standard deviations (SD) a participant has from the population normal values. The body weight z-scores were designed to take into account the amount of weight gain that was expected due to normal growth in children and adolescents. Body weight data were converted to Z-scores using the Statistical Analysis System (SAS) programs provided by the Centers for Disease Control (CDC) for the calculation of the 2000 CDC growth charts. The mean (SD) change in Z scores from b
Interventions
- DRUG Levetiracetam
- DRUG Topiramate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2014-10-06 |
| Est. Completion | 2020-04-30 |
| Phase | Phase 3 |
What the finished NCT02201251 record still lists
NCT02201251 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Levetiracetam is the first listed.
NCT02201251 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02201251 about?
NCT02201251 is a clinical study titled "A Study to Investigate the Safety of the Drugs Topiramate and Levetiracetam in Treating Children Recently Diagnosed With Epilepsy". The purpose of this study is to evaluate the safety of topiramate monotherapy compared with levetiracetam another standard antiepileptic drug (AED), as monotherapy for new-onset or recent-onset epilepsy (seizure disorder) on pediatric growth and maturation, bone mineralization, and kidney stone form...
What is the current status of trial NCT02201251?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 63 participants. The study started on 2014-10-06. Estimated completion is 2020-04-30.
What interventions are being tested in trial NCT02201251?
The interventions under investigation include: Levetiracetam (DRUG), Topiramate (DRUG).
Who is sponsoring clinical trial NCT02201251?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02201251's enrollment target sits among peer trials
63 1800th of 2000 higher than 199 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03383575 · 63 participants · Phase 2
Azacitidine and Enasidenib in Treating Patients With IDH2-Mutant Myelodysplastic Syndrome
- NCT04870944 · 63 participants · Phase 1
CBL0137 for the Treatment of Relapsed or Refractory Solid Tumors, Including CNS Tumors and Lymphoma
- NCT05031897 · 63 participants · Phase 2
Two Step Haplo With Radiation Conditioning
- NCT05312671 · 63 participants · Phase 2
Atezolizumab Plus Etoposide and Platinum in Small Cell Bladder Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI