Childhood Absence Epilepsy Rx PK-PD-Pharmacogenetics Study
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|ClinicalTrials.gov Identifier: NCT00088452|
Recruitment Status : Completed
First Posted : July 27, 2004
Last Update Posted : February 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Childhood Absence Epilepsy Petit Mal Epilepsy Epilepsy Seizures||Drug: ethosuximide Drug: lamotrigine Drug: valproic acid||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||453 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Childhood Absence Epilepsy Rx PK-PD-Pharmacogenetics Study|
|Actual Study Start Date :||July 2004|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||August 31, 2016|
U.S. FDA Resources
Active Comparator: 1
Ethosuximide is a common treatment for childhood absence epilepsy.
Active Comparator: 2
Lamotrigine is a common treatment for childhood absence epilepsy.
Active Comparator: 3
Drug: valproic acid
Valproic acid is a common treatment for childhood absence epilepsy.
- treatment failure [ Time Frame: evaluated during study period 2 weeks to 5 years ]
- Omission errors and the overall Confidence Index(CIOI)of the CPT-II and the K-CPT--for attention. [ Time Frame: evaluated during study period, 2 weeks to 5 years ]
- CBCL--for behavior. [ Time Frame: evaluated during study period, 2 weeks to 5 years ]
- QOLCE--for quality of life. [ Time Frame: evaluated during study period, 2 weeks to 5 years ]
- Freedom from seizures. [ Time Frame: evaluated during study period, 2 weeks to 5 years ]
- Having a treatment-limiting adverse event. [ Time Frame: evaluated during study period, 2 weeks to 5 years ]
- Drug exposure levels and metabolite levels. [ Time Frame: evaluated during study period, 2 weeks to 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00088452
Show 31 Study Locations
|Principal Investigator:||Tracy A. Glauser, MD||Professor of Pediatrics and Neurology and Director of the Comprehensive Epilepsy Center, Cincinnati Children's Hospital Medical Center|
|Principal Investigator:||Peter Adamson, MD||Professor of Pediatrics and Pharmacology, Chief of Division of Clinical Pharmacology and Therapeutics, Director of Office of Clinical and Translational Research, Children's Hospital of Philadelphia|
|Principal Investigator:||Avital Cnaan, PhD||Director, Multi-Center Studies Section, Children's National Medical Center|