Last updated: 11/03/2018 13:49:39

Lamotrigine Pregnancy Registry (LAM05)

GSK study ID
112913
See study documents
Clinicaltrials.gov ID
NCT01064297
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Lamotrigine Pregnancy Registry (LAM05)
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Birth outcomes by earliest pregnancy trimester of exposure to lamotrigine monotherapy

Timeframe: Although reports and diagnoses of major congenital malformations are accepted up to six years after the birth, the majority of malformations are reported after assessments made in the delivery room or shortly after birth

Birth outcomes by earliest pregnancy trimester of exposure to lamotrigine polytherapy with valproate

Timeframe: Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported following assessments made in the delivery room or shortly after birth

Birth outcomes by earliest pregnancy trimester of exposure to lamotrigine polytherapy without valproate

Timeframe: Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported following assessments made in the delivery room or shortly after birth

Number of infants with major congenital malformations by earliest trimester of exposure to lamotrigine monotherapy

Timeframe: Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported after assessments made in the delivery room or shortly after birth

Number of infants with major congenital malformations (MCMs) by earliest trimester of exposure to Lamotrigine polytherapy with valproate

Timeframe: Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported following assessments made in the delivery room or shortly after birth

Number of infants with major congenital malformations (MCMs) by earliest trimester of exposure to lamotrigine polytherapy without valproate

Timeframe: Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported following assessments made in the delivery room or shortly after birth

Number of infants with the indicated major congenital malformations following the first trimester of exposure to lamotrigine monotherapy according to dose received

Timeframe: Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported after assessments made in the delivery room or shortly after birth

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

Timeframe: Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported after assessments made in the delivery room or shortly after birth

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

Timeframe: Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported after assessments made in the delivery room or shortly after birth

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Lamotrigine monotherapy
  • Drug: Lamotrigine polytherapy including valproate
  • Drug: Lamotrigine polytherapy without valproate
    • Enrollment:
    3416
    Primary completion date:
    2010-15-07
    Observational study model:
    Cohort
    Time perspective:
    Prospective
    Clinical publications:
    Cunnington MC, Weil JG, Messenheimer JA, Ferber S, Yerby M, Tennis P. Final results from 18 years of the International Lamotrigine Pregnancy Registry. [Neurology]. 2011;76(21):1817-183.
    Cunnington, M.C., Ferber S., Quartey G., and the International Lamotrigine Pregnancy Registry Scientific Advisory Committee. Effect of Dose on the Frequency of Major Birth Defects Following Fetal Exposure to Lamotrigine Monotherapy in an International Observational Study. Epilepsia. 2007; 48(6): 1207-10.
    Cunnington, M.C., Tennis P., and The International Lamotrigine Pregnancy Registry Scientific Advisory Committee. Pregnancy Outcomes over 11 years of monitoring in the International Lamotrigine Pregnancy Registry. Neurology. 2005. 64: 955-60.
    Cunnington, M.C. The International Lamotrigine Pregnancy Registry Update for the Epilepsy Foundation. Epilepsia.. 2004. 45(11): 1468.
    Lamotrigine Pregnancy Registry. Interim Report 1 September 1992 through 31 March 2010. Issued July 2010. Available at: http://pregnancyregistry.gsk.com/index.html
    Tennis P,. Eldridge R., and The International Lamotrigine Pregnancy Registry Scientific Advisory Committee. Preliminary results on pregnancy outcomes in women using lamotrigine. Epilepsia. 2002; 43(10): 1161-7.
    Cunnington MC, Weil JG, Messenheimer JA, Ferber S, Yerby M, Tennis P. Final results from 18 years of the International Lamotrigine Pregnancy Registry. Neurology. 2011;76(21):1817-23.
    Medical condition
    Epilepsy, Bipolar Disorder
    Product
    lamotrigine
    Collaborators
    Not applicable
    Study date(s)
    November 2001 to July 2010
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female
    Age
    Not applicable+ years
    Accepts healthy volunteers
    No
    • 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 reviewed separately and descriptively. These are not included in risk analyses.
    • Patient reported exposures and outcomes that are not verified by a healthcare provider.
    Inclusion and exclusion 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.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2010-15-07
    Actual study completion date
    2010-15-07

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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