This study is being conducted to determine the safety and tolerability of lamotrigine in elderly patients with...
Date First Received: August 13, 2007
Last Updated: July 8, 2008
Verified by: GlaxoSmithKline, July 2008
Clinical Trial Phase: Phase 3 | Start Date: July 2007
Overall Status: Recruiting
Estimated Enrollment: 170
Brief Summary
Official Title: “Lamotrigine Extended-Release in Elderly Patients With Epilepsy”
Condition Keyword(s):
Intervention(s):
This study is being conducted to determine the safety and tolerability of lamotrigine in elderly patients with epilepsy
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Study Primary Completion Date: September 2009
Intervention(s) in this Clinical Trial
- Drug: Lamotrigine
Outcome Measures for this Clinical Trial
Primary Measures
- Frequency of treatment-emergent adverse events at 15 weeks and 28 weeks
Secondary Measures
- Frequency of treatment-emergent adverse events at 15 weeks and 28 weeks
- Serum concentration of lamotrigine at 4,7,11,15,24 and 28 weeks Changes in seizure control at 15 weeks and 28 weeks Changes in safety assessments (vital signs, hematology and blood chemistry, lipid levels) at 15 weeks and 28 weeks
- Serum concentration of lamotrigine
- Time Frame: at 4,7,11,15,24 and 28 weeks
- Time Frame: at 4,7,11,15,24 and 28 weeks
- Changes in seizure control Changes in safety assessments (vital signs, hematology and blood chemistry, lipid levels)
- Time Frame: at 15 weeks and 28 weeks
- Time Frame: at 15 weeks and 28 weeks
Criteria for Participation in this Clinical Trial
Inclusion criteria:
- Confident diagnosis of epilepsy
- Currently treated with one or two antiepileptic medications
- Able to complete a seizure diary
Exclusion criteria:
- History of hypersensitivity to lamotrigine
- Progressive diseases that would interfere with the study objectives
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 65 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: GlaxoSmithKline
Overall Clinical Trial Officials and Contacts
GSK Clinical Trials, Call Centre Study Director GlaxoSmithKline
Additional Information
Information obtained from ClinicalTrials.gov on September 05, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00516139
Study ID Number: LEP105972
ClinicalTrials.gov Identifier: NCT00516139
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
