Last updated: 11/07/2018 16:29:23
GlaxoSmithKline International Lamotrigine Pregnancy Registry
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: GlaxoSmithKline International Lamotrigine Pregnancy Registry
Trial description: GlaxoSmithKline International Lamotrigine Pregnancy Registry
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Centers for Disease Control and Prevention: Metropolitan Atlanta Congenital Defects Program Procedure Manual. July 1989 (Revised January 1998); A1-B11. To access a copy of the MACDP defect code, please go to http://www.cdc.gov/ncbddd/bd/macdp_resources.htm and click on the link to the .pdf file.
Correa-Villasenor A, Cragan J, Kucik J, O’Leary L, Siffel C, Williams L. The Metropolitan Atlanta Congenital Defects Program: 35 years of birth defects surveillance at the Centers for Disease Control and Prevention. Birth Defects Research (Part A) 2003;67:617-624.
Cunnington, M.C. The International Lamotrigine Pregnancy Registry Update for the Epilepsy Foundation. Epilepsia.. 2004. 45(11): 1468.
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.
Fleiss JL. Statistical Methods for Rates and Proportions. New York: John Riley; 1981;14-15. Holmes LB, Harvey EA, Coull BA, Huntington KB, Khoshbin S, Hayes AM, Ryan LM. The teratogenicity of anticonvulsant drugs. N Engl J Med 2001;344(15):1132-1138
Holmes LB, Wyszynski DF, Baldwin EJ, Haebecker E, Glassman LH, Smith CR. Increased risk for nonsyndromic cleft palate among infants exposed to lamotrigine during pregnancy (abstract): Birth Defect Research Part A: Clinical and Molecular Teratology 2006;76(5)318.
Lamotrigine Pregnancy Registry. Interim Report 1 September 1992 through 30 September 1996. Issued January 2007. Available at: http://pregnancyregistry.gsk.com/index.html
Morrow JI, Craig JJ, Russell AJC, Irwin B, Guthrie E, Morrison P, Parsons L, Robertson I. Which antiepileptic drugs are safest in pregnancy? Epilepsia 2003;44(suppl 8):60.
Morrow JI, Russell A, Craig JJ, Morrison P, Robertson I, Guthrie E, Parsons L. Major malformations in the offspring of women with epilepsy: a comprehensive prospective study. Epilepsia 2001;42(suppl 2):125.
Morrow JI, Russell A, Gutherie E, Parsons L, Robertson I, Waddell R, Irwin B, Morrison P, McGivern CR, Craig J. Malformation risks of anti-epileptic drugs in pregnancy: A prospective study from the UK Epilepsy and Pregnancy Register. J Neurol Neurosurg Psy 2006;77:193-198.
Samren EB, Van Dujjin CM, Christiaens GCML, Hoffman A, Lindout D. Antiepileptic drug regimens and major congenital abnormalities in the offspring. Ann Neurol 1999;46:739-746.
Medical condition
Bipolar Disorder
Product
lamotrigine
Collaborators
Not applicable
Study date(s)
September 1992 to September 2007
Type
Not applicable
Phase
4
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2007-30-09
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website