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Observational Study of Lamotrigine

NCT ID: NCT00299793

Last Updated: 2007-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2001-10-31

Brief Summary

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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.

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Detailed Description

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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

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Epilepsy

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Patients with mental retardation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

Northwell Health

OTHER

Sponsor Role lead

Principal Investigators

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Alan Ettinger, MD

Role: PRINCIPAL_INVESTIGATOR

Northwell Health

Locations

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Long Island Jewish Medical Center

New Hyde Park, New York, United States

Site Status

Countries

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United States

Other Identifiers

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01.08.110

Identifier Type: -

Identifier Source: org_study_id

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