Childhood Absence Epilepsy Rx PK-PD-Pharmacogenetics Study
Information source: National Institute of Neurological Disorders and Stroke (NINDS)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Childhood Absence Epilepsy; Petit Mal Epilepsy; Epilepsy; Seizures
Intervention: ethosuximide (Drug); lamotrigine (Drug); valproic acid (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Children's Hospital Medical Center, Cincinnati Official(s) and/or principal investigator(s):
Tracy A. Glauser, MD, Principal Investigator, Affiliation: Professor of Pediatrics and Neurology and Director of the Comprehensive Epilepsy Program, Cincinnati Children's Hospital Medical Center
Peter Adamson, MD, Principal Investigator, Affiliation: 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
Avital Cnaan, PhD, Principal Investigator, Affiliation: Professor of Biostatistics in Pediatrics, The Children's Hospital of Philadelphia
Summary
The purpose of this study is to determine the best initial treatment for childhood absence
epilepsy.
Clinical Details
Official title: Childhood Absence Epilepsy Rx PK-PD-Pharmacogenetics Study
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment
Primary outcome: treatment failure
Secondary outcome: Omission errors and the overall Confidence Index(CIOI)of the CPT-II and the K-CPT--for attention.CBCL--for behavior. QOLCE--for quality of life. Freedom from seizures. Having a treatment-limiting adverse event. Drug exposure levels and metabolite levels.
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.
Eligibility
Minimum age: 30 Months.
Maximum age: 13 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Diagnosis: Clinical diagnosis of Childhood Absence Epilepsy consistent with the
International League against Epilepsy Proposal for Revised Classification of
Epilepsies and Epileptic Syndromes (3).
- EEG: Interictal EEG demonstrating bilateral synchronous symmetrical approximate 3 Hz
spike waves on a normal background with at least one burst lasting >/= (greater than
or equal to) 3 seconds.
- Age > 2. 5 years and < 13 years of age at study entry.
- Body weight >/= (greater than or equal to) 10 kilograms.
- Body Mass Index: BMI for age =/< 99th percentile (based on the CDC BMI for age growth
curves for boys/girls [http://www. cdc. gov/growthcharts], Appendix 1).
- Hepatic:
- AST/ALT < 2. 5 times the upper limit of normal
- Total bilirubin < 1. 5 times the upper limit of normal.
- Hematologic:
- Absolute neutrophil count >/= (greater than or equal to) 1500/mm3.
- Platelets >/= (greater than or equal to) 120, 000 /mm3.
- Female subjects must be premenarchal at the time of enrollment and must be willing to
practice abstinence for the duration of the study.
- Parent/legal guardian(s) willing to sign an IRB approved informed consent.
- Subject assent (when appropriate and as dictated by local IRB).
Exclusion Criteria:
- Treatment for CAE with anti-seizure medications (AED) for a period of greater than 7
days prior to randomization.
- History of a major psychiatric disease (e. g., psychosis, major depression).
- History of autism or pervasive development disorder.
- History of non-febrile seizures other than typical absence seizures. This includes a
history of an afebrile generalized tonic clonic seizure.
- Clinical signs and symptoms consistent with a diagnosis of juvenile absence epilepsy
or juvenile myoclonic epilepsy as delineated by the International League against
Epilepsy Proposal for Revised Classification of Epilepsies and Epileptic Syndromes
(3).
- History of recent or present significant or medical disease, i. e., cardiovascular,
hepatic, renal, gynecologic, musculoskeletal, metabolic, or endocrine.
- History of a severe dermatologic reaction (e. g., Stevens Johnson, toxic epidermolysis
necrosis) to medication.
- Subject or parent/legal guardian might not be reasonably expected to be compliant with
or to complete the study.
- Participation in a trial of an investigational drug or device within 30 days prior to
screening.
- Use of systemic contraceptive for any indication, including acne.
Locations and Contacts
The Children's Hospital of Alabama, Birmingham, Alabama 35233, United States
St. Joseph's Hospital and Medical Center, Phoenix, Arizona 85013, United States
Arkansas Children's Hospital, Little Rock, Arkansas 72202, United States
Mattel Children's Hospital at UCLA, Los Angeles, California 90095, United States
University of California at San Diego, LaJolla, California 92093, United States
Children's Hospital of Denver, Denver, Colorado 80218, United States
Yale University School of Medicine, New Haven, Connecticut 06520, United States
Children's National Medical Center, Washington, District of Columbia 20010, United States
Miami Children's Hospital, Miami, Florida 33155, United States
Nemours Children's Clinic, Jacksonville, Florida 32207, United States
Children's Healthcare of Atlanta, Atlanta, Georgia 30342, United States
Children's Memorial Hospital, Chicago, Illinois 60614, United States
Children's Hospital of Michigan, Detroit, Michigan 48201, United States
Washington University in St. Louis, St. Louis, Missouri 63110, United States
Montefiore Medical Center, Bronx, New York 10467, United States
NYU Comprehensive Epilepsy Center, Manhattan, New York, New York 10016, United States
Women and Children's Hospital of Buffalo, Buffalo, New York 14222, United States
Cincinnati Children's Hospital, Cincinnati, Ohio 45229, United States
Children's Hospital, Inc., PCTI, Columbus, Ohio 43205, United States
Rainbow Babies & Children's Hospital, Cleveland, Ohio 44106, United States
Doernbecher Children's Hospital, Portland, Oregon 97239, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 19104, United States
Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania 15213, United States
LeBonheur Children's Medical Center, Memphis, Tennessee 38103, United States
Texas Children's Hospital, Houston, Texas 77030, United States
Dallas Pediatric Neurology Associates, Dallas, Texas 75230, United States
Cook Children's Medical Center, Ft. Worth, Texas 76104, United States
University of Utah/Primary Children's Medical Center, Salt Lake City, Utah 84113, United States
Children's Hospital of The King's Daughter (Monarch Medical Research), Norfolk, Virginia 23510, United States
Children's Hospital & Regional Medical Center, Seattle, Washington 98105-0371, United States
Children's Hospital of Wisconsin, Milwaukee, Wisconsin 53201-1997, United States
Additional Information
Starting date: July 2004
Ending date: November 2008
Last updated: December 19, 2007
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