Developmental Delay in Children Exposed During Pregnancy to Either Lamotrigine,Sodium Valproate, or Carbamazepine

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Massachusetts General Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01097720
First received: March 31, 2010
Last updated: NA
Last verified: March 2010
History: No changes posted
  Purpose

This study is investigating the neurodevelopmental effects of prenatal exposure to lamotrigine (LTG), sodium valproate (VPA), or carbamazepine (CBZ) monotherapies. The hypotheses to be tested include:

  1. Exposure during pregnancy to CBZ, LTG, and VPA, each as monotherapy, is associated with developmental delay with or without signs of autism.
  2. Exposure to each drug (CBZ, LTG, and VPA) as monotherapy is associated with an increased rate of occurrence of major malformations.
  3. The child with major malformations is more likely to have developmental delay with or without signs of autism than the child who does not have major malformations.
  4. The occurrence of adaptive behavior outcomes will show a dose-response relationship with the dose of medication taken by the mother in the first trimester.

The study population includes children 36-83 months of age who were exposed throughout gestation to one of the three drugs of interest, as treatment for maternal seizure disorder.


Condition
Autism
Developmental Delay
Birth Defects

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Developmental Delay in Children Exposed During Pregnancy to Either Lamotrigine, Sodium Valproate, or Carbamazepine

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Adaptive Behavior Scores [ Time Frame: 36-83 months of age ] [ Designated as safety issue: No ]
    Measures of each child's Adaptive Behavior scores as assessed by the Vineland-II Adaptive Behavior Scales, collected when the child was between 36 and 83 months of age.


Secondary Outcome Measures:
  • Presence/Absence of Major Malformations [ Time Frame: 36-83 months of age ] [ Designated as safety issue: No ]
    Based on interview with mother and review of medical records, determination is made as to whether or not the child had any major malformations at birth.


Enrollment: 298
Study Start Date: March 2005
Estimated Study Completion Date: September 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
LTG-exposed
Children exposed to LTG during pregnancy.
VPA-exposed
Children exposed to VPA during pregnancy.
CBZ-exposed
Children exposed to CBZ during pregnancy.

  Eligibility

Ages Eligible for Study:   36 Months to 83 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Children 36-83 months of age, prenatally exposed to LTG, VPA, or CBZ monotherapies, recruited through mothers enrolled in the North American Antiepileptic Drug Pregnancy Registry.

Criteria

Inclusion Criteria:

  • 36-83 months of age
  • Prenatal exposure to LTG, VPA, or CBZ monotherapy
  • AED was used by mother to suppress seizures
  • Mother was enrolled in the North American AED Pregnancy Registry

Exclusion Criteria:

  • Exposure during the first trimester to other known teratogens.
  • Mother with mental health issues
  • Refusal to release medical records to confirm eligibility.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01097720

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
GlaxoSmithKline
Investigators
Principal Investigator: Lewis B. Holmes, MD Massachusetts General Hospital
Study Director: Jane Adams, Ph.D. University of Massachusetts, Boston
  More Information

No publications provided

Responsible Party: Lewis B. Holmes, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01097720     History of Changes
Other Study ID Numbers: 2005P000379
Study First Received: March 31, 2010
Last Updated: March 31, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Valproate
Lamotrigine
Carbamazepine
Anticonvulsant
Antiepileptic
Teratogen
Autism
Developmental Delay

Additional relevant MeSH terms:
Congenital Abnormalities
Carbamazepine
Lamotrigine
Valproic Acid
Analgesics
Analgesics, Non-Narcotic
Anticonvulsants
Antimanic Agents
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Enzyme Inhibitors
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
GABA Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Sodium Channel Blockers
Therapeutic Uses
Tranquilizing Agents
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on October 20, 2014