Observational Study of Lamotrigine

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT00299793
First received: March 3, 2006
Last updated: March 22, 2007
Last verified: March 2007

March 3, 2006
March 22, 2007
October 2001
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Complete list of historical versions of study NCT00299793 on ClinicalTrials.gov Archive Site
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Observational Study of Lamotrigine
Observational Study of Lamotrigine

The purpose of this study is to assess efficacy, safety and tolerability of lamotrigine as used in a natural clinical setting, to examine the positive effects of lamotrigine, and the reasons why some patients choose to continue or discontinue lamotrigine.

There have been numerous randomized, double-blind controlled trials demonstrating the value of lamotrigine in the treatment of seizures. However, randomized trials take place in artificial experimental conditions with many restrictions imposed. There hasn't been much focus on positive effects on the patient, such as improvement in mood and level of alertness related to the drug. Other factors related to quality of life that affect the decision to continue or discontinue the drug are also important. Anecdotal experience suggests that lamotrigine is associated with increased alertness, enhanced energy levels and improved general sense of well-being. Observational studies that promote awareness of such distinguishing features and other aspects of efficacy are essential for guiding decision-making when prescribing anti-epileptic drugs.

Observational
Additional Descriptors: Psychosocial
Observational Model: Defined Population
Time Perspective: Longitudinal
Time Perspective: Prospective
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Epilepsy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
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Inclusion Criteria:

  • Patients who are about to be prescribed lamotrigine as an appropriate treatment for their epileptic disorder

Exclusion Criteria:

  • Patients with mental retardation
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00299793
01.08.110
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North Shore Long Island Jewish Health System
GlaxoSmithKline
Principal Investigator: Alan Ettinger, MD North Shore Long Island Jewish Health System
North Shore Long Island Jewish Health System
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP