Last updated: 01/07/2025 08:50:19
Pooled analysis to evaluate the safety of lamotrigine in women with epilepsy
GSK study ID
219103
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Trial overview
Official title: Pooled analysis to evaluate the safety of lamotrigine and placebo in a sub-group of women with epilepsy (WWE) of childbearing age (13-45 years) from adjunctive studies in refractory focal seizures
Trial description: This pooled analysis is aimed at examining the safety of lamotrigine and placebo in the women aged 13–45 years with epilepsy by analyzing this subpopulation from 11 adjunctive double-blind placebo-controlled studies.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Rates of Adverse events (AEs)
Timeframe: Up to 52 weeks
Change in weight
Timeframe: Up to 52 weeks
Incidence of rash
Timeframe: Up to 52 weeks
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2023-23-05
Observational study model:
Other
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Epilepsy
Product
lamotrigine
Collaborators
Not applicable
Study date(s)
February 2023 to May 2023
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female
Age
13 - 45 Years
Accepts healthy volunteers
No
- Women of childbearing age (13-45 years) with refractory focal seizures receiving up to 2-3 baseline anti-epileptic drugs (AEDs) and randomized to either lamotrigine or placebo during the double-blind treatment phase of these 11 clinical studies will be included in this analysis. Individual participants’ data from these 11 studies will be pooled for analysis.
- Women above the age of 45 years and less than 13 years
- Men with epilepsy
Inclusion and exclusion criteria
Inclusion criteria:
- Women of childbearing age (13-45 years) with refractory focal seizures receiving up to 2-3 baseline anti-epileptic drugs (AEDs) and randomized to either lamotrigine or placebo during the double-blind treatment phase of these 11 clinical studies will be included in this analysis. Individual participants’ data from these 11 studies will be pooled for analysis.
Exclusion criteria:
- Women above the age of 45 years and less than 13 years
- Men with epilepsy
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Other
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
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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