Last updated: 11/07/2018 17:24:12
An Open-label, Multi-Center, Cross-Sectional Observational Study Comparing the Prevalence of Metabolic and Menstrual Disturbances in Women with Epilepsy on Lamotrigine or Valproate Monotherapy
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: An Open-label, Multi-Center, Cross-Sectional Observational Study Comparing the Prevalence of Metabolic and Menstrual Disturbances in Women with Epilepsy on Lamotrigine or Valproate Monotherapy
Trial description: An Open-label, Multi-Center, Cross-Sectional Observational Study Comparing the Prevalence of Metabolic and Menstrual Disturbances in Women with Epilepsy on Lamotrigine or Valproate Monotherapy
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:
Abstract: Comparison of lamotrigine to placebo in infants 1-24 months of age with partial seizures: impact of response during open-label enrichment phase. Warnock, Clay R BS , Caldwell, Paul T MS , and Messenheimer, John A MD 59th Annual Meeting of the American Epilepsy Society held jointly with the American Clinical Neurophysiology Society 12/2/2005 Washington, DC; USA
Abstract: Long-term safety of lamotrigine in pediatric subjects with partial seizures preliminary results. AYALA, Ricardo MD, ELTERMAN, Roy MD, MIKATI, Mohamad MD, PINA-GARZA, J. Eric MD, GUCUYENER, Kivilcim MD, WARNOCK, Clay R., and MESSENHEIMER, John MD 58th Annual Meeting of the American Epilepsy Society 12/3/2004 New Orleans, LA; USA
Abstract: Safety and efficacy of lamotrigine in infants age 1-24 months with partial seizures: updated preliminary open-label results. J.E. Piiia-Garza, K. Gucuyener C. R. Wamock H. S. Conklin D. Morrison J. A. Messenheimer 25th International Epilepsy Congress 10/12/2003 Lisbon; Portugal
Abstract: Safety and efficacy of lamotrigine in subjects 1-24 months of age with partial seizures- double-blind phase results. Pina-Garza, J. Eric , Levisohn, Paul , Gucuyener, Kivilcim , Mikati, Mohamad , Warnock, Clay R. , and Messenheimer, John 5 57th Annual Meeting of the American Academy of Neurology 4/9/2005 Miami Beach, FL; USA
Abstract: Safety and eflicacy of lamatrigine in infants aged 1 to 24 months with partial seizures: updaled preliminary open-label results. JE Piga-Garza, K. Gucuyener C R. Warnock H. S. Conklin D. Morrison andj. A. Messenheimer and 32nd Annual Meeting of the Child Neurology Society 10/1/2003 Miami Beach, FL; USA
Abstract: safety and efficacy of lamotrigine in infants aged 1 to 24 months with partial seizures: updated preliminary open-label results. Piña-Garza, J. E., Gucuyener, K., Warnock, C. R., Conklin, H. S., Morrison, D., and Messenheimer, J. A. 32nd Annual Meeting of the Child Neurology Society 10/1/2003 Miami Beach, FL; USA
Morrell MJ, Isojarvi J, Taylor AE, Dam M, Ayala, R, Gomez, G, O’Neill F, Tennis, P, Messenheimer, J, Higher androgens and weight gain with valproate compared with lamotrigine for epilepsy, Epilepsy Research 54 (2003) 189-199.
Medical condition
Epilepsy
Product
lamotrigine
Collaborators
Not applicable
Study date(s)
April 1999 to May 2000
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
2000-16-05
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
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