Phase 3
N=453
Childhood Absence Epilepsy Rx PK-PD-Pharmacogenetics Study
Childhood Absence Epilepsy · Petit Mal Epilepsy · Epilepsy · Seizures
Bottom Line
View on ClinicalTrials.gov: NCT00088452 ↗Enrolled (actual)
453
Serious AEs
1.8%
Results posted
Oct 2020
Primary outcome: Primary: Number of Participants With Freedom From Treatment Failure at 16-20 Weeks of Double Blind Therapy — 81; 43; 85 Participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ethosuximide (Drug); Lamotrigine (Drug); Valproic acid (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Freedom From Treatment Failure at 16-20 Weeks of Double Blind Therapy |
81; 43; 85 | <0.001 sig |
| SECONDARY Number of Participants With Attention Deficit as Measured by the Confidence Index of the CPT-II and the K-CPT |
35; 25; 52 | 0.03 sig |
| SECONDARY Number of Participants With Freedom From Treatment Failure at 12 Months of Double Blind Therapy |
70; 31; 64 | <0.001 sig |
Summary
The purpose of this study is to determine the best initial treatment for childhood absence epilepsy.
Eligibility 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 /= (greater than or equal to) 10 kilograms.
- Body Mass Index: BMI for age =/ /= (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.
Data sourced from ClinicalTrials.gov (NCT00088452). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.