Overview

This trial has been completed.

Condition epilepsy
Treatment lamotrigine tablets
Sponsor GlaxoSmithKline
Start date April 2009
End date July 2016
Trial size 850 participants
Trial identifier NCT01863602, 112728

Summary

The objectives of this post-marketing surveillance (PMS) are to grasp the actual use of lamotrigine tablets to collect safety information in the long-term use according to seizure type and concomitant antiepileptic drug (AED), and to confirm its efficacy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective prospective
Arm
Subjects with epilepsy with partial seizures, tonic-clonic seizuresm or generalized seizures of Lennox-Gastaut syndrome to whom lamotrigine tablets are administered.
lamotrigine tablets
Administered for long-term according to the prescribing information in the locally approved label by the authorities.

Primary Outcomes

Measure
The incidence of adverse drug reactions
time frame: 1 year
Occurrence of skin disorder after the start of treatment
time frame: 1 year

Secondary Outcomes

Measure
Overall improvement of subjects' symptoms
time frame: 1 year

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Subjects with epilepsy with partial seizures, tonic-clonic seizuresm or generalized seizures of Lennox-Gastaut syndrome - Subjects who are treated with lamotrigine tablets Exclusion Criteria:

Additional Information

Official title Special Drug Use Investigation for LAMICTAL (Long Term)
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by GlaxoSmithKline.