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

Autism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01097720
• Other study ID #: 2005P000379
• Status: Active, not recruiting
• Phase: N/A
• First received: March 31, 2010
• Last updated: March 31, 2010
• Start date: March 2005
• Est. completion date: September 2010

Study information

• Verified date: March 2010
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 298
• Est. completion date: September 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 36 Months to 83 Months

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Autism
• Birth Defects
• Congenital Abnormalities
• Developmental Delay

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adaptive Behavior Scores	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.	36-83 months of age	No
Secondary	Presence/Absence of Major Malformations	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.	36-83 months of age	No