Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Observational Study of Lamotrigine

This study has been completed.
Information provided by:
North Shore Long Island Jewish Health System Identifier:
First received: March 3, 2006
Last updated: March 22, 2007
Last verified: March 2007

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.

Condition Phase
Phase 4

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Official Title: Observational Study of Lamotrigine

Resource links provided by NLM:

Further study details as provided by North Shore Long Island Jewish Health System:

Estimated Enrollment: 60
Study Start Date: October 2001
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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients with mental retardation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00299793

United States, New York
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
Sponsors and Collaborators
North Shore Long Island Jewish Health System
Principal Investigator: Alan Ettinger, MD North Shore Long Island Jewish Health System
  More Information

No publications provided Identifier: NCT00299793     History of Changes
Other Study ID Numbers: 01.08.110
Study First Received: March 3, 2006
Last Updated: March 22, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by North Shore Long Island Jewish Health System:
Quality of life processed this record on February 27, 2015