NCT00088452

Childhood Absence Epilepsy Rx PK-PD-Pharmacogenetics Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 453 (actual)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 30 Months – 13 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

Childhood absence epilepsy (CAE) is a common pediatric epilepsy syndrome that affects 10 to 15 percent of all children with epilepsy. Individuals with CAE have brief staring spell seizures that occur suddenly, unpredictably, and frequently throughout the day. These seizures impair the children's ability to learn and play, and lead to higher injury rates. There are many medications used to treat seizures, but only 3 generally are used as the first treatment for children with CAE: ethosuximide, lamotrigine, and valproic acid. The goal of this study is to determine which of these 3 medicines is the best first choice as treatment for children with CAE. Approximately 439 children, recruited over a 3-year period at 32 medical centers in the US, will take part in this 5-year study. Participants will be randomly given one of the 3 common CAE treatments-ethosuximide, lamotrigine, or valproic acid-and will make regular visits to a clinic every 1 to 3 months for approximately 2 years. During the visits, participants will undergo regular testing to determine if the medicine is working, to watch for side effects, and to help researchers learn more about the responses to these medicines. In addition, researchers hope to develop methods that may be used in the future to help choose the best medicine for each individual diagnosed with CAE. Also included in the study will be pharmacokinetics and pharmacogenetics research. Pharmacokinetics is the study of how the body absorbs, distributes, metabolizes, and excretes drugs. Pharmacogenetics is the study of genetic determinants of the response to drugs. Knowledge gained from this study may lead to individualized treatment for children with CAE, and may also be beneficial for other pediatric and adult seizure disorders.

Conditions

• Childhood Absence Epilepsy
• Petit Mal Epilepsy
• Epilepsy
• Seizures

Interventions

Type	Name	Description
DRUG	Ethosuximide	Ethosuximide is a common treatment for childhood absence epilepsy.
DRUG	Lamotrigine	Lamotrigine is a common treatment for childhood absence epilepsy.
DRUG	Valproic acid	Valproic acid is a common treatment for childhood absence epilepsy.

Timeline

• Start date: 2004-07-01
• Primary completion: 2013-01-01
• Completion: 2016-08-31
• First posted: 2004-07-27
• Last updated: 2020-10-14
• Results posted: 2020-10-14

Locations

31 sites across 1 country: United States