Observational Study of Lamotrigine
Information source: North Shore Long Island Jewish Health System
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Epilepsy
Phase: Phase 4
Status: Completed
Sponsored by: North Shore Long Island Jewish Health System Official(s) and/or principal investigator(s):
Alan Ettinger, MD, Principal Investigator, Affiliation: North Shore Long Island Jewish Health System
Summary
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.
Clinical Details
Official title: Observational Study of Lamotrigine
Study design: Psychosocial, Longitudinal, Defined Population, Prospective Study
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients who are about to be prescribed lamotrigine as an appropriate treatment for
their epileptic disorder
Exclusion Criteria:
- Patients with mental retardation
Locations and Contacts
Long Island Jewish Medical Center, New Hyde Park, New York 11040, United States
Additional Information
Starting date: October 2001
Last updated: March 22, 2007
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