CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 453 enrolled
Drug / intervention
Ethosuximide +2 moredrug
Likely dose
Not stated in record
Key inclusion· 6
  • ✓Clinical diagnosis of Childhood Absence Epilepsy per ILAE classification
  • ✓Interictal EEG with bilateral synchronous symmetrical ~3 Hz spike waves on normal background, at least one burst ≥3 seconds
  • ✓Age >2.5 and <13 years at entry
  • ✓Body weight ≥10 kg
Key exclusion· 8
  • ✕Prior AED treatment for >7 days before randomization
  • ✕History of major psychiatric disease (psychosis, major depression)
  • ✕History of autism or pervasive developmental disorder
  • ✕History of non-febrile seizures other than typical absence seizures, including afebrile generalized tonic-clonic seizures

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00088452
NCT00088452Phase 3Completed
CompareCT.gov

Childhood Absence Epilepsy Rx PK-PD-Pharmacogenetics Study

Children's Hospital Medical Center, Cincinnati·interventional·Posted Jul 27, 2004·Updated Oct 14, 2020

In Brief

A Phase 3 clinical trial evaluating Ethosuximide, Lamotrigine, and 1 other intervention for Childhood Absence Epilepsy and 3 related conditions. Completed, enrolled 453 participants across 31 sites.

Detailed Summary

The purpose of this study is to determine the best initial treatment for childhood absence epilepsy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChildhood Absence Epilepsy, Petit Mal Epilepsy, Epilepsy, Seizures
CountriesUnited States
CollaboratorsNational Institute of Neurological Disorders and Stroke (NINDS)

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 27, 2004
Enrollment StartJul 1, 2004
Primary CompletionJan 1, 2013
Study CompletionAug 31, 2016
TodayJul 2, 2026
Enrollment to primary: 8.5 yearsPosted 21.9 years ago

Interventions

Ethosuximidedrug

Ethosuximide is a common treatment for childhood absence epilepsy.

Lamotriginedrug

Lamotrigine is a common treatment for childhood absence epilepsy.

Valproic aciddrug

Valproic acid is a common treatment for childhood absence epilepsy.