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NCT00088452 · ClinicalTrials.gov registry record · Phase 3
Childhood Absence Epilepsy Rx PK-PD-Pharmacogenetics Study
A Phase 3 study of Epilepsy and Seizures, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- Phase 3
- Development phase
- 453
- Enrollment target
- 20
- Study locations
NCT00088452: Completed Phase 3 study of Epilepsy and Seizures, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT00088452 is a Phase 3 study of Epilepsy and Seizures that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 453 participants, below the 950-participant average among 160 other Epilepsy trials with a reported enrollment target (52% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00088452, a Phase 3 study of Epilepsy and Seizures, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 453 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to determine the best initial treatment for childhood absence epilepsy.
Primary Outcome
Treatment failure was defined as persistence of absence seizures at week 16 or week 20, a generalized tonic-clonic seizure at any time, excessive drug-related systemic toxicity, a moderately severe rash (possibly drug-related), pancreatitis, or increase in the body-mass index of at least 3.0 from baseline, dose-limiting toxicity after a single downward dose modification, or withdrawal initiated by the parent or physician.
Conditions Studied
Interventions
- DRUG Lamotrigine
- DRUG Ethosuximide
- DRUG Valproic acid
Study Locations (20)
New York
- Women and Children's Hospital of Buffalo - Buffalo
- NYU Comprehensive Epilepsy Center, Manhattan - New York
- Montefiore Medical Center - The Bronx
Ohio
- Cincinnati Children's Hospital - Cincinnati
- Rainbow Babies & Children's Hospital - Cleveland
- Children's Hospital, Inc., PCTI - Columbus
California
- University of California at San Diego - La Jolla
- Mattel Children's Hospital at UCLA - Los Angeles
Florida
- Nemours Children's Clinic - Jacksonville
- Miami Children's Hospital - Miami
Alabama
- The Children's Hospital of Alabama - Birmingham
Arizona
- St. Joseph's Hospital and Medical Center - Phoenix
Arkansas
- Arkansas Children's Hospital - Little Rock
Colorado
- Children's Hospital of Denver - Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 453 participants |
| Start Date | 2004-07 |
| Est. Completion | 2016-08-31 |
| Phase | Phase 3 |
What the finished NCT00088452 record still lists
NCT00088452 is an interventional study that assigns participants to a tested intervention. The registered 453 participants enrollment target is mid-sized for trials with a published cap, below the 950-participant average among 160 other Epilepsy trials with a reported enrollment target (52% lower).
The record links to 4 conditions, with Epilepsy appearing as the primary indexed condition, and to 3 interventions - of which Lamotrigine is the first listed.
NCT00088452 names 20 study sites across 14 states, led by New York, Ohio, California.
Frequently Asked Questions
What is clinical trial NCT00088452 about?
NCT00088452 is a clinical study titled "Childhood Absence Epilepsy Rx PK-PD-Pharmacogenetics Study". The purpose of this study is to determine the best initial treatment for childhood absence epilepsy.
What is the current status of trial NCT00088452?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 453 participants. The study started on 2004-07. Estimated completion is 2016-08-31.
What conditions does trial NCT00088452 study?
This clinical trial studies the following conditions: Epilepsy, Seizures, Childhood Absence Epilepsy, Petit Mal Epilepsy.
What interventions are being tested in trial NCT00088452?
The interventions under investigation include: Lamotrigine (DRUG), Ethosuximide (DRUG), Valproic acid (DRUG).
Who is sponsoring clinical trial NCT00088452?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00088452 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Epilepsy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00088452's enrollment target sits among peer trials
453 15th of 160 higher than 146 of 160 other Epilepsy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Epilepsy 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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