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NCT00299793 Clinical Trial

Observational Study of Lamotrigine

Epilepsy Clinical Trial

Official title:
Observational Study of Lamotrigine

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00299793
Other study ID # 01.08.110
Secondary ID
Status Completed
Phase Phase 4
First received March 3, 2006
Last updated March 22, 2007
Start date October 2001

Study information
Verified date March 2007
Source Northwell Health
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

Locations
Country Name City State
United States Long Island Jewish Medical Center New Hyde Park New York

Sponsors (2)
Lead Sponsor Collaborator
Northwell Health GlaxoSmithKline

Country where clinical trial is conducted

United States, 

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