Last updated: 11/04/2018 08:35:10
Study Evaluating LAMICTAL Extended-Release Therapy Added To Current Seizure Treatments In Patients With Partial Seizures
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Multicenter, Double-Blind, Randomized, Parallel-group Evaluation of LAMICTAL Extended-release Adjunctive Therapy in Subjects with Partial Seizures
Trial description: This study is being conducted to compare the efficacy and safety of LAMICTAL (lamotrigine) extended-release with placebo in the treatment of partial seizures. LAMICTAL extended-release is an investigational drug. Placebo tablets look like LAMICTAL extended-release tablets but do not contain active medication. In this study, LAMICTAL extended-release or placebo tablets will be added to current seizure treatments.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Median percent change from baseline in partial seizure frequency during the entire double-blind treatment phase.
Timeframe: Baseline (Week 4 before treatment) and Week 19
Secondary outcomes:
Median percent change from baseline in partial seizure frequency during the escalation phase, the maintenance phase, and during the last 8 weeks of the maintenance phase
Timeframe: Baseline (Week 4 before treatment) and escalation phase (Week 3 and Week 7), maintenance phase (Week 11, 15 and week 19) and Last 8 Weeks of Maintenance phase
Number of participants with ≥25%, ≥50%, ≥75% or 100% reduction in partial seizure frequency during the entire double-blind treatment phase, the escalation phase, the maintenance phase, and the last 8 weeks of the maintenance phase
Timeframe: Entire double-blind treatment phase (Week 19), escalation phase (Week 3 and Week 7), maintenance phase (Week 11, 15 and week 19),and Last 8 Weeks of Maintenance phase
Number of participants with 50% reduction in seizure frequency for all partial seizures at different timepoints
Timeframe: Weeks 2,4,8,12, 16, and Week 19
Number of participants with treatment-emergent adverse events (AEs) and serious adverse events (SAE)
Timeframe: Up to Week 19
Change from Baseline in body weight
Timeframe: Baseline (4 weeks before treatment) and Week 19
Number of participants with improved clinical status on the investigator assessment of participant’s clinical status questionnaire
Timeframe: Up to Week 19
Participant’s satisfaction with seizure control at end of study
Timeframe: Up to week 19
PK parameter: Total clearance (CL/F) of lamotrigine from plasma after oral adminstarion
Timeframe: Up to Week 19
PK parameter: Volume distribution (V/F) of lamotrigine after oral administration
Timeframe: Up to week 19
PK parameter: Absorption rate constant (Ka) for lamotrigine
Timeframe: up to week 19
Change from baseline in Profile of Mood States (POMS) score
Timeframe: Baseline (4 weeks before treatment) and Week 19
Change from baseline in Center for Epidemiological Studies- Depression Scale (CES-D) score
Timeframe: Baseline (4 weeks before treatment) and Week 19
Change from baseline in the Neurological Disorders Depression Inventory-Epilepsy (NDDI-E, 46-item research version) score
Timeframe: Baseline (4 weeks before treatment) and Week 19
Change from baseline in the Quality of Life in Epilepsy (QOLIE-31P) score
Timeframe: Baseline (4 weeks before treatment) and Week 19
Change from baseline in the Liverpool Adverse Experience Profile (LAEP) score
Timeframe: Baseline (4 weeks before treatment) and Week 19
Change from Baseline in the Seizure Severity Questionnaire (SSQ) score
Timeframe: Baseline (4 weeks before treatment) and Week 19
Change from baseline in the Epworth Sleepiness Scale (ESS) score
Timeframe: Baseline (4 weeks before treatment) and Week 19
Interventions:
Enrollment:
236
Primary completion date:
2007-26-07
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
D. K. Naritoku, C. R. Warnock, J. A. Messenheimer, R. Borgohain, S. Evers, A. B. Guekht, V. A. Karlov, B. I. Lee and L. Ríos Pohl: Lamotrigine extended-release as adjunctive therapy for partial seizures. Neurology 2007;69;1610-1618
Erratum: Lamotrigine extended-release as adjunctive therapy for partial seizures. Neurology 2009;72;201
Medical condition
Epilepsy
Product
lamotrigine
Collaborators
Not applicable
Study date(s)
October 2004 to July 2007
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
13+ years
Accepts healthy volunteers
No
- Diagnosis of epilepsy with partial seizures for more than 24 weeks.
- Must experience at least 8 partial seizures during an 8-week Baseline Phase.
- Previous treatment with lamotrigine.
- Exhibits any primary generalized seizures.
Inclusion and exclusion criteria
Inclusion criteria:
- Diagnosis of epilepsy with partial seizures for more than 24 weeks.
- Must experience at least 8 partial seizures during an 8-week Baseline Phase.
- Must currently be receiving treatment with a stable regimen of one or two antiepileptic drugs for at least four weeks.
- Patient or parent/caregiver must be willing and able to maintain a written daily seizure diary.
Exclusion criteria:
- Previous treatment with lamotrigine.
- Exhibits any primary generalized seizures.
- Receiving treatment with felbamate or currently following the ketogenic diet.
- Pregnant, breastfeeding, or planning to become pregnant.
Trial location(s)
Location
GSK Investigational Site
San Antonio, Texas, United States, 78258
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35294-0021
Status
Study Complete
Location
GSK Investigational Site
Northport, Alabama, United States, 35476
Status
Study Complete
Location
GSK Investigational Site
San Juan, Puerto Rico, Puerto Rico, 00918
Status
Study Complete
Location
GSK Investigational Site
Chemnitz, Sachsen, Germany, 09111
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73112
Status
Study Complete
Location
GSK Investigational Site
Austell, Georgia, United States, 30106
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Minneapolis, Minnesota, United States, 55422
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85006
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Halle, Sachsen-Anhalt, Germany, 06118
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Baesweiler, Nordrhein-Westfalen, Germany, 52499
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bochum, Nordrhein-Westfalen, Germany, 44892
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Campinas, São Paulo, Brazil, 13083-970
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Grand Rapids, Michigan, United States, 49525
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Plainview, New York, United States, 11803
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Maitland, Florida, United States, 32751
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Richmond, Virginia, United States, 23220
Status
Study Complete
Location
GSK Investigational Site
Washington, District of Columbia, United States, 20016
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53215
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Edison, New Jersey, United States, 08818
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Unterhaching, Bayern, Germany, 82008
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Asheville, North Carolina, United States, 28801
Status
Study Complete
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30342
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19107
Status
Study Complete
Location
GSK Investigational Site
Scottsdale, Arizona, United States, 85259
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bernburg, Sachsen-Anhalt, Germany, 06406
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Minneapolis, Minnesota, United States, 55454
Status
Study Complete
Location
GSK Investigational Site
Hamburg, Hamburg, Germany, 20249
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Chesterfield, Missouri, United States, 63017
Status
Study Complete
Location
GSK Investigational Site
Bueckeburg, Niedersachsen, Germany, 31675
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Tampa, Florida, United States, 33609
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Jena, Thueringen, Germany, 07743
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Capital Federal, Buenos Aires, Argentina, 1181
Status
Study Complete
Location
GSK Investigational Site
Kansas City, Missouri, United States, 64111
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73104
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Des Moines, Iowa, United States, 50309-1426
Status
Terminated/Withdrawn
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63110
Status
Study Complete
Location
GSK Investigational Site
Hamburg, Hamburg, Germany, 21029
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Sun City, Arizona, United States, 85351
Status
Study Complete
Location
GSK Investigational Site
Wichita Falls, Texas, United States, 76301
Status
Study Complete
Location
GSK Investigational Site
Santa Monica, California, United States, 90404
Status
Study Complete
Location
GSK Investigational Site
Salt Lake City, Utah, United States, 84107
Status
Terminated/Withdrawn
Location
GSK Investigational Site
New York, New York, United States, 10016
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Tuscaloosa, Alabama, United States, 35406
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Muenchen, Bayern, Germany, 80331
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile
Status
Study Complete
Location
GSK Investigational Site
Jena-Lobeda, Thueringen, Germany, 07747
Status
Study Complete
Location
GSK Investigational Site
Lexington, Kentucky, United States, 40536-0284
Status
Study Complete
Location
GSK Investigational Site
Wuerzburg, Bayern, Germany, 97070
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Boston, Massachusetts, United States, 02118
Status
Study Complete
Location
GSK Investigational Site
Muenster, Nordrhein-Westfalen, Germany, 48149
Status
Study Complete
Location
GSK Investigational Site
San German, Puerto Rico, Puerto Rico, 00683
Status
Study Complete
Location
GSK Investigational Site
Frankfurt, Hessen, Germany, 60594
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Newport Beach, California, United States, 92660
Status
Study Complete
Location
GSK Investigational Site
Galveston, Texas, United States, 77555
Status
Study Complete
Location
GSK Investigational Site
Chicago, Illinois, United States, 60612
Status
Study Complete
Location
GSK Investigational Site
Hyderabad, Andhra Pradesh, India, 500482
Status
Study Complete
Location
GSK Investigational Site
Greenville, North Carolina, United States, 27834
Status
Terminated/Withdrawn
Location
GSK Investigational Site
West Orange, New Jersey, United States, 07052
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Crestview Hills, Kentucky, United States, 41017
Status
Study Complete
Location
GSK Investigational Site
Augusta, Georgia, United States, 30912
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Springfield, Illinois, United States, 62702
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90073
Status
Study Complete
Location
GSK Investigational Site
Detroit, Michigan, United States, 48202
Status
Study Complete
Location
GSK Investigational Site
Ulm, Baden-Wuerttemberg, Germany, 89073
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Cheswick, Pennsylvania, United States, 15024
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Wismar, Mecklenburg-Vorpommern, Germany, 23966
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bochum, Nordrhein-Westfalen, Germany, 44795
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Singen, Baden-Wuerttemberg, Germany, 78224
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Tallahassee, Florida, United States, 32308
Status
Study Complete
Location
GSK Investigational Site
Naumburg, Sachsen-Anhalt, Germany, 06618
Status
Study Complete
Location
GSK Investigational Site
Columbus, Ohio, United States, 43210-1250
Status
Study Complete
Location
GSK Investigational Site
Straubing, Bayern, Germany, 94315
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 50672
Status
Study Complete
Location
GSK Investigational Site
Greensburg, Pennsylvania, United States, 15601
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Moenchengladbach, Nordrhein-Westfalen, Germany, 41061
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Savannah, Georgia, United States, 31405
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Hattingen, Nordrhein-Westfalen, Germany, 45525
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45122
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Los Angeles, California, United States, 90033
Status
Study Complete
Location
GSK Investigational Site
Kiel, Schleswig-Holstein, Germany, 24105
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Washington, District of Columbia, United States, 20037
Status
Study Complete
Location
GSK Investigational Site
Anniston, Alabama, United States, 36207
Status
Study Complete
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89103
Status
Study Complete
Location
GSK Investigational Site
Osnabrueck, Niedersachsen, Germany, 49074
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Chapel Hill, North Carolina, United States, 27514
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Boston, Massachusetts, United States, 02215
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19140
Status
Study Complete
Location
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45138
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Wismar, Mecklenburg-Vorpommern, Germany, 23970
Status
Study Complete
Location
GSK Investigational Site
Ludwigsfelde, Brandenburg, Germany, 14974
Status
Study Complete
Location
GSK Investigational Site
Louisville, Kentucky, United States, 40202
Status
Study Complete
Location
GSK Investigational Site
Magdeburg, Sachsen-Anhalt, Germany, 39104
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Sepuldeva, California, United States, 91343
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27607
Status
Study Complete
Location
GSK Investigational Site
Seattle, Washington, United States, 98122-4358
Status
Study Complete
Location
GSK Investigational Site
San Juan, Puerto Rico, Puerto Rico, 00936
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bernau, Brandenburg, Germany, 16321
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Neuoetting, Bayern, Germany, 84524
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 50767
Status
Study Complete
Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
Status
Study Complete
Location
GSK Investigational Site
Hollywood, Florida, United States, 33021
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Limburgerhof, Rheinland-Pfalz, Germany, 67117
Status
Study Complete
Location
GSK Investigational Site
Magdeburg, Sachsen-Anhalt, Germany, 39124
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Goettingen, Niedersachsen, Germany, 37075
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Traverse City, Michigan, United States, 49684
Status
Study Complete
Location
GSK Investigational Site
Flossmoor, Illinois, United States, 60422
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2007-26-07
Actual study completion date
2007-26-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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