Developmental Effects On Children Of Women Who Take Antiepileptic Drugs During Pregnancy
This study has been completed.
Sponsor:
Emory University
Collaborator:
Information provided by (Responsible Party):
Kimford J. Meador, MD, Emory University
ClinicalTrials.gov Identifier:
NCT00021866
First received: August 8, 2001
Last updated: March 18, 2013
Last verified: March 2013
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Purpose
The purpose of this study is to determine if antiepileptic drugs (AEDs) differ in their neurodevelopmental effects. Specifically, do the children of the women with epilepsy differ in their behavioral and cognitive development depending on which AED their mother takes during pregnancy?
| Condition | Intervention |
|---|---|
|
Epilepsy Seizure Cognition Disorders |
Behavioral: Differential Abilities Scale Behavioral: Neuropsychological Testing |
| Study Type: | Observational |
| Study Design: | Observational Model: Family-Based Time Perspective: Prospective |
| Official Title: | Neurodevelopmental Effects of Antiepileptic Drugs II: the NEAD Study |
Resource links provided by NLM:
Genetics Home Reference related topics:
pyridoxal 5'-phosphate-dependent epilepsy
Drug Information available for:
Phenytoin
Valproic acid
Carbamazepine
Phenytoin sodium
Valproate sodium
Divalproex sodium
Lamotrigine
U.S. FDA Resources
Further study details as provided by Emory University:
Primary Outcome Measures:
- Child IQ as measured by the Differential Abilities Scale at 6 Years of age [ Time Frame: 6 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Executive Functioning,Tower-NEPSY [ Time Frame: 6 Years ] [ Designated as safety issue: No ]
- Linguistic Functioning via Expressive one word vocabulary test and NEPSY subscales [ Time Frame: 6 Years ] [ Designated as safety issue: No ]
- Visual-Spatial Motor Functioning via NEPSY subscale and Visual-Motor Integration Scale [ Time Frame: 6 Years ] [ Designated as safety issue: No ]
- Memory via Children's Memory Scale [ Time Frame: 6 Years ] [ Designated as safety issue: No ]
- Motor Functioning via Grooved Pegboard [ Time Frame: 6 Years ] [ Designated as safety issue: No ]
- Academic Functioning via Wide Range Achievement Test [ Time Frame: 6 Years ] [ Designated as safety issue: No ]
- Adaptive Functioning via Adaptive Behavior System -2nd Edition [ Time Frame: 6 Years ] [ Designated as safety issue: No ]
- Behavior via Behavior Assessment for Children & Parent Stress Index [ Time Frame: 6 Years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Venous blood for AED levels Cord Blood for G6PD, Homocysteine Saliva for drug metabolizing enzymes, antioxidant enzymes, DNA repair enzymes, drug membrane transporter proteins and folate-related genes
| Enrollment: | 331 |
| Study Start Date: | September 2000 |
| Study Completion Date: | August 2012 |
| Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Carbamazepine
Children and their mothers exposed to Carbamazepine monotherapy in utero
|
Behavioral: Differential Abilities Scale
IQ measurement at 3, 4.5 and 6 years of age
Other Name: DAS
Behavioral: Neuropsychological Testing
Tests of memory, attention, and behavior administered at 2,3, 4.5 and 6 Years of age
Other Names:
|
|
Phenytoin
Children and their mothers exposed to phenytoin in utero
|
Behavioral: Differential Abilities Scale
IQ measurement at 3, 4.5 and 6 years of age
Other Name: DAS
Behavioral: Neuropsychological Testing
Tests of memory, attention, and behavior administered at 2,3, 4.5 and 6 Years of age
Other Names:
|
|
Lamotrigine
Children and their mothers exposed to Lamotrigine in utero
|
Behavioral: Differential Abilities Scale
IQ measurement at 3, 4.5 and 6 years of age
Other Name: DAS
Behavioral: Neuropsychological Testing
Tests of memory, attention, and behavior administered at 2,3, 4.5 and 6 Years of age
Other Names:
|
|
Valproate
Children and their mothers exposed to Valproate in utero
|
Behavioral: Differential Abilities Scale
IQ measurement at 3, 4.5 and 6 years of age
Other Name: DAS
Behavioral: Neuropsychological Testing
Tests of memory, attention, and behavior administered at 2,3, 4.5 and 6 Years of age
Other Names:
|
Detailed Description:
This is a prospective investigation enrolling 285 to 380 women with epilepsy during the first two trimesters of their pregnancies. There are 25 clinical centers as well as the database center. The women will be taking one of the following AEDs: carbamazepine, phenytoin, valproate, or lamotrigine. Cognitive and behavioral testing of the child will be done up to the age of 6 years. The study does not change the woman's doctor and does not interfere with the care of the treating physician.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Mothers and their child(ren) who were exposed to one of the following monotherapies in utero- Lamotrigine, Carbamazepine, Phenytoin, or Valproate. Fathers of the children and a first degree materal relative of the mother are also invited to have IQ testing and medical history
Criteria
- Subject must be diagnosed with partial seizures and/or secondary generalization or primary generalized seizures (absence, atonic, myoclonic, and generalized tonic-clonic seizures)
- Subjects must be on either carbamazepine, lamotrigine, phenytoin, or valproate monotherapy.
- Mothers must not have a history of drug abuse (including alcohol) in the last year and have no sequelae of drug abuse.
- Mothers must be able to maintain an accurate seizure diary of major motor seizures
- Subjects must have an IQ greater than or equal to 70 points.
- Subjects must have a history of a negative RPR and HIV.
- Subjects must not have progressive cerebral disease or presence of other major medical illness
- Subjects must not have exposure to known teratogens during pregnancy, except AEDs.
- Subjects must not have poor compliance with prenatal care.
- Subjects must have adequate reading skills to perform the cognitive tests.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00021866
Show 21 Study Locations
Show 21 Study LocationsSponsors and Collaborators
Emory University
Investigators
| Principal Investigator: | Kimford J. Meador, M.D. | Emory University, Atlanta |
More Information
Additional Information:
Publications:
Meador KJ, Chadwick D, Clayton-Smith J, Pennell P, Liporace J, Kalayian L, and NEAD Study Group. Antiepileptic drugs in pregnancy: Differences in U.K. and U.S.A. Epilepsia, 2003;44 (Suppl. 9):289.
Meador KJ, Page P, Liporace J, Kalayjian L, NEAD Study Group. Antiepileptic Drugs in Pregnancy. Neurology 2004;62 (Suppl 5):A311.
Meador KJ, Baker GA, Clayton Smith J, Pennell P, Liporace J, Kalayjian L, Kini U, NEAD Study Group. Differential Effects of Antiepileptic Drugs on Serious Adverse Outcomes in Children Exposed In Utero. Epilepsia 2004;45 (Suppl 3):58
Meador KM, Loring DW, Baker G, Smith JC, Pennell P, Liporace J, Kalayjian L, Kini U, NEAD Study Group. Differential and dose dependent effects of in utero antiepileptic drugs. Neurology 2005;64 (Suppl 1):A427
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Kimford J. Meador, MD, Professor, Emory University |
| ClinicalTrials.gov Identifier: | NCT00021866 History of Changes |
| Other Study ID Numbers: | R01NS038455, 2RO1NS38455, 2R01NS038455-06 |
| Study First Received: | August 8, 2001 |
| Last Updated: | March 18, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Emory University:
|
epilepsy seizure pregnancy antiepileptic AED carbamazepine |
phenytoin valproate lamotrigine child behavior |
Additional relevant MeSH terms:
|
Cognition Disorders Epilepsy Seizures Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Signs and Symptoms Lamotrigine Anticonvulsants Phenytoin Valproic Acid Carbamazepine |
Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action GABA Agents Neurotransmitter Agents Physiological Effects of Drugs Antimanic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Analgesics, Non-Narcotic Analgesics Sensory System Agents |
ClinicalTrials.gov processed this record on May 22, 2013