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Special Drug Use Investigation for LAMICTAL® (Long Term)

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: October 4, 2012
Last updated: November 8, 2016
Last verified: November 2016
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.

Condition Intervention
Drug: Lamotrigine tablets

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Special Drug Use Investigation for LAMICTAL (Long Term)

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • The incidence of adverse drug reactions [ Time Frame: 1 year ]
  • 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 Outcome Measures:
  • 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.

Enrollment: 850
Study Start Date: April 2009
Study Completion Date: July 2016
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Subjects prescribed lamotrigine tablets
Subjects with epilepsy with partial seizures, tonic-clonic seizuresm or generalized seizures of Lennox-Gastaut syndrome to whom lamotrigine tablets are administered.
Drug: Lamotrigine tablets
Administered for long-term according to the prescribing information in the locally approved label by the authorities.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Adult (>=15 to <65 years) and pediatric (>=2 to <15 years) subjects with epilepsy with the following seizure type who use lamotrigine tablets

  • Partial seizures
  • Tonic-clonic seizures
  • Generalized seizures of Lennox-Gastaut syndrome

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:

  Contacts and Locations
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Please refer to this study by its identifier: NCT01863602

Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline Identifier: NCT01863602     History of Changes
Other Study ID Numbers: 112728
Study First Received: October 4, 2012
Last Updated: November 8, 2016

Additional relevant MeSH terms:
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers processed this record on May 25, 2017