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Special Drug Use Investigation for LAMICTAL® (Long Term)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01863602
First Posted: May 29, 2013
Last Update Posted: November 9, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
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
Epilepsy 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.

  Eligibility

Information from the National Library of Medicine

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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
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01863602


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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01863602     History of Changes
Other Study ID Numbers: 112728
First Submitted: October 4, 2012
First Posted: May 29, 2013
Last Update Posted: November 9, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Lamotrigine
Anticonvulsants
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