Last updated: 02/11/2021 09:10:07
LAMICTAL Special Drug Use Investigation(mono-therapy for Typical Absence Seizure)
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: LAMICTAL Special Drug Use Investigation（mono-therapy for Typical Absence Seizure）
Trial description: This post-marketing surveillance (PMS) study is conducted to assess the information about safety and effectiveness in pediatric epilepsy patients (aged less than 15 years) with typical absence seizures in routine medical practice. LAMICTAL is a registered trademark of the GSK group of companies.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
The incidence of adverse drug reactions
Timeframe: 6 months
Secondary outcomes:
Not applicable
Interventions:
Drug: Lamotrigine tablets
Enrollment:
20
Observational study model:
Case-Only
Primary completion date:
2019-05-09
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Epilepsy
Product
lamotrigine
Collaborators
Not applicable
Study date(s)
June 2016 to September 2019
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
15+ years
Accepts healthy volunteers
Not applicable
- Pediatric patients with typical absence seizures
- Pediatric patients who receive lamotrigine monotherapy for the first time
- None
Inclusion and exclusion criteria
Inclusion criteria:
- Pediatric patients with typical absence seizures
- Pediatric patients who receive lamotrigine monotherapy for the first time
Exclusion criteria:
- None
Trial location(s)
No location data available.
Study documents
Clinical study report
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2019-05-09
Actual study completion date
2019-05-09
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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