NCT00299793

Observational Study of Lamotrigine

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 60 (planned)
• Sponsor: Northwell Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Epilepsy

Timeline

• Start date: 2001-10-01
• First posted: 2006-03-07
• Last updated: 2007-03-23

Locations

1 site across 1 country: United States