Observational Study of Lamotrigine

Completed

• Conditions: Epilepsy

• Registration Number: NCT00299793
• Lead Sponsor: Northwell Health

Brief 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.

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.

Study Timeline

• Study Start: 2001-10
• Study First Submitted: 2006-03-03
• Study First Submitted QC: 2006-03-03
• Study First Posted: 2006-03-07
• Status Verified: 2007-03
• Last Update Submitted: 2007-03-22
• Last Update Posted: 2007-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

• Patients with mental retardation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Long Island Jewish Medical Center; 🇺🇸 New Hyde Park, New York, United States