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Sponsors and Collaborators: |
North Shore Long Island Jewish Health System GlaxoSmithKline |
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Information provided by: | North Shore Long Island Jewish Health System |
ClinicalTrials.gov Identifier: | NCT00299793 |
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.
Study Type: | Observational |
Study Design: | Psychosocial, Longitudinal, Defined Population, Prospective Study |
Official Title: | Observational Study of Lamotrigine |
Estimated Enrollment: | 60 |
Study Start Date: | October 2001 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |
Long Island Jewish Medical Center | |
New Hyde Park, New York, United States, 11040 |
Principal Investigator: | Alan Ettinger, MD | North Shore Long Island Jewish Health System |
Study ID Numbers: | 01.08.110 |
Study First Received: | March 3, 2006 |
Last Updated: | March 22, 2007 |
ClinicalTrials.gov Identifier: | NCT00299793 |
Health Authority: | United States: Institutional Review Board |
Epilepsy Quality of life |
Calcium, Dietary Epilepsy Lamotrigine |
Quality of Life Central Nervous System Diseases Brain Diseases |
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Therapeutic Uses Nervous System Diseases Calcium Channel Blockers |
Cardiovascular Agents Central Nervous System Agents Anticonvulsants Pharmacologic Actions |