N/A
N=3,416
Lamotrigine Pregnancy Registry (LAM05)
Epilepsy · Bipolar Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01064297 ↗Enrolled (actual)
3,416
Serious AEs
2.6%
Results posted
Oct 2010
Primary outcome: Primary: Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Monotherapy — 31; 4; 1; 0 infants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Lamotrigine monotherapy (Drug); Lamotrigine polytherapy including valproate (Drug); Lamotrigine polytherapy without valproate (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Monotherapy |
31; 4; 1; 0; 1; 0 | — |
| PRIMARY Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy With Valproate |
14; 1; 0; 0; 0; 0 | — |
| PRIMARY Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy Without Valproate |
11; 0; 1; 0; 0; 0 | — |
| PRIMARY Number of Infants With Major Congenital Malformations by Earliest Trimester of Exposure to Lamotrigine Monotherapy |
35; 4; 1; 0; 40 | — |
| PRIMARY Number of Infants With Major Congenital Malformations (MCMs) by Earliest Trimester of Exposure to Lamotrigine Polytherapy With Valproate |
14; 1; 0; 0; 1 | — |
| PRIMARY Number of Infants With Major Congenital Malformations (MCMs) by Earliest Trimester of Exposure to Lamotrigine Polytherapy Without Valproate |
12; 0; 1; 13 | — |
| PRIMARY Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received |
2; 0; 1; 0; 2; 0 | — |
| PRIMARY Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy With Valproate According to Dose of Lamotrigine Received |
1; 0; 1; 0; 1; 0 | — |
| PRIMARY Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy Without Valproate According to Dose of Lamotrigine Received |
0; 0; 1; 0; 1; 1 | — |
Summary
Antiepileptic drugs (AEDs) are not indicated for use in pregnancy. However, women with epilepsy, and other approved indications including bipolar disorder, may require or be unintentionally exposed to AEDs during pregnancy. Prior to an AED being marketed there are few data available on drug safety in pregnancy: data from animal models may not translate directly to humans and pregnant women are routinely excluded from clinical trials. The International Lamotrigine Pregnancy Registry was established by GlaxoSmithKline (GSK) in 1992 to monitor the safety of lamotrigine during pregnancy.
Eligibility Criteria
Inclusion Criteria
- Women exposed in utero to lamotrigine (as monotherapy or in a polytherapy combination) during pregnancy. Exposure can occur at any time during pregnancy, though exposure in the first trimester is of primary interest.
- Pregnancies exposed to lamotrigine and reported before the outcome of the pregnancy is known (prospective reporting). Ideally exposed pregnancies are registered prior to prenatal testing, but only those pregnancies enrolled after prenatal testing has diagnosed a birth defect are excluded.
- Retrospectively reported exposures (i.e. exposures registered once the pregnancy outcome is known) are included in the registry, but are considered descriptively and are not included in risk analyses.
Exclusion Criteria
- Retrospectively reported exposures (i.e. exposures registered once the pregnancy outcome is known) are included in the registry, but are reviewed separately and descriptively. These are not included in risk analyses.
- Patient reported exposures and outcomes that are not verified by a healthcare provider.
Data sourced from ClinicalTrials.gov (NCT01064297). 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.