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Drug Use Investigation for LAMICTAL

Drug Use Investigation for LAMICTAL

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01376180
Enrollment
3000
Registered
2011-06-20
Start date
2008-12-31
Completion date
2016-08-31
Last updated
2016-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

Brief summary

The purpose of this study is to grasp actual status of usage of lamotrigine tablet and to collect information for using lamotrigine tablet effectively and safely as well as to grasp onset status of adverse events in pediatric subjects, geriatric subjects, pregnant women, subjects with poor renal and hepatic functions.

Interventions

DRUGLamotrigine

Administered according to the prescribing information in the locally approved label by the authorities

Sponsors

GlaxoSmithKline
Lead SponsorINDUSTRY

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Subjects with epilepsy having the following seizure types. * Partial seizures (including secondary generalized seizures) * Tonic-clonic seizures * Generalized seizures of Lennox-Gastaut syndrome

Exclusion criteria

\- None

Design outcomes

Primary

MeasureTime frame
The number of adverse events in Japanese subjects with epilepsy treated with lamotrigine tablet6 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026