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Patients With Epilepsy Taking LAMICTAL Immediate-Release Who Switch To Extended-Release Formulation And Vice Versa

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00264615
First received: December 9, 2005
Last updated: September 22, 2016
Last verified: September 2016
  Purpose
Pharmacokinetic (PK) study to characterize changes in serum concentrations in epilepsy patients when switching from LAMICTAL immediate-release to extended-release and vice versa.

Condition Intervention Phase
Epilepsy
Drug: lamotrigine extended-release
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Official Title: An Open-label, Double Conversion Study to Characterize the Pharmacokinetics of Lamotrigine When Switching Patients With Epilepsy on LAMICTAL Immediate-release to Extended-release Formulation and Vice Versa

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Steady state AUC(0-24), Cmax and Ct (approximate Cmin) of lamotrigine [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tmax and fluctuation index of lamotrigine [ Designated as safety issue: No ]
  • Adverse events, changes in blood pressure and heart rate [ Designated as safety issue: No ]
  • Change in seizure frequency during each of the study phases [ Designated as safety issue: No ]
  • Subject preference at End of Baseline and Extended-Release Treatment Phases [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: October 2005
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   13 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Confident diagnosis of epilepsy.
  • Currently on LAMICTAL and up to 2 concomitant AEDs (anti-epileptic drugs).

Exclusion Criteria:

  • Females of childbearing potential cannot be on hormonal contraceptives or hormone replacement therapy.
  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 ClinicalTrials.gov identifier: NCT00264615

Locations
United States, Alabama
GSK Investigational Site
Anniston, Alabama, United States, 36207
United States, Arizona
GSK Investigational Site
Sun City, Arizona, United States, 85351
United States, Kentucky
GSK Investigational Site
Lexington, Kentucky, United States, 40503
GSK Investigational Site
Lexington, Kentucky, United States, 40536-0284
United States, Massachusetts
GSK Investigational Site
Boston, Massachusetts, United States, 02215
United States, Nevada
GSK Investigational Site
Reno, Nevada, United States, 89521
United States, New York
GSK Investigational Site
New York, New York, United States, 10016
United States, Ohio
GSK Investigational Site
Toledo, Ohio, United States, 43614-5809
United States, Pennsylvania
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19140
United States, Tennessee
GSK Investigational Site
Nashville, Tennessee, United States, 37232
United States, Texas
GSK Investigational Site
Dallas, Texas, United States, 75230
United States, Virginia
GSK Investigational Site
Richmond, Virginia, United States, 23219
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Publications:
Study Data/Documents: Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: LEP103944
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: LEP103944
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: LEP103944
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: LEP103944
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: LEP103944
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: LEP103944
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: LEP103944
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00264615     History of Changes
Other Study ID Numbers: LEP103944 
Study First Received: December 9, 2005
Last Updated: September 22, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
once daily dosing
seizure
pharmacokinetics
epilepsy

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Lamotrigine
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers

ClinicalTrials.gov processed this record on September 26, 2016