Skip to main content
OpenTrials
Completed

NCT Number: NCT01863602

Special Drug Use Investigation for LAMICTAL® (Long Term)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • None

Treatment and study plan

Lamotrigine tablets

Drug

Administered for long-term according to the prescribing information in the locally approved label by the authorities.

Primary outcomes

  1. The incidence of adverse drug reactions

    Time frame: 1 year

  2. Occurrence of skin disorder after the start of treatment

    Time frame: 1 year

    Presence or absence of skin disorder and its details after the start of treatment will be investigated as a priority investigation item

Secondary outcomes

  1. Overall improvement of subjects' symptoms

    Time frame: 1 year

    Investigators will assess the overall improvement as "remarkably improved". "improved", "slightly improved", "unchanged" or "worsened" on the basis of the degree of change in frequency of seizures, strength, span and other related symptoms.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Special Drug Use Investigation for LAMICTAL (Long Term)

Important dates

Study start
2009
Primary completion
2016
Study completion
2016
First posted
May 29, 2013
Registry last updated
Nov 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.