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EpilepsyPhase 3NCT00113165

Study Evaluating LAMICTAL Extended-Release Therapy Added To Current Seizure Treatments In Patients With Partial Seizures

A Phase 3 study testing LAMICTAL extended-release in people with Epilepsy and Epilepsy, Partial, run by GlaxoSmithKline at 148 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 13 years and older
Conditions the study is for
Epilepsy, Epilepsy, Partial
What is being tested?
LAMICTAL extended-release
How many people
244 participants
Where
148 sitesin 10 countries
Study dates
Oct 2004to Jul 2007
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

148 sites in 10 countries.

148 sites in 10 countries

United States70 sites

  • GSK Investigational Site

    Anniston, Alabama, 36207

  • GSK Investigational Site

    Asheville, North Carolina, 28801

  • GSK Investigational Site

    Atlanta, Georgia, 30342

  • GSK Investigational Site

    Augusta, Georgia, 30912

  • GSK Investigational Site

    Austell, Georgia, 30106

  • GSK Investigational Site

    Birmingham, Alabama, 35294-0021

  • GSK Investigational Site

    Boston, Massachusetts, 02118

  • GSK Investigational Site

    Boston, Massachusetts, 02215

  • GSK Investigational Site

    Chapel Hill, North Carolina, 27514

  • GSK Investigational Site

    Chesterfield, Missouri, 63017

  • GSK Investigational Site

    Cheswick, Pennsylvania, 15024

  • GSK Investigational Site

    Chicago, Illinois, 60612

  • GSK Investigational Site

    Columbus, Ohio, 43210-1250

  • GSK Investigational Site

    Crestview Hills, Kentucky, 41017

  • GSK Investigational Site

    Dallas, Texas, 75230

  • GSK Investigational Site

    Dallas, Texas, 75235

  • GSK Investigational Site

    Des Moines, Iowa, 50309-1426

  • GSK Investigational Site

    Detroit, Michigan, 48202

  • GSK Investigational Site

    Edison, New Jersey, 08818

  • GSK Investigational Site

    Flossmoor, Illinois, 60422

  • GSK Investigational Site

    Galveston, Texas, 77555

  • GSK Investigational Site

    Grand Rapids, Michigan, 49525

  • GSK Investigational Site

    Greensburg, Pennsylvania, 15601

  • GSK Investigational Site

    Greenville, North Carolina, 27834

  • GSK Investigational Site

    Hollywood, Florida, 33021

  • GSK Investigational Site

    Houston, Texas, 77005

  • GSK Investigational Site

    Kansas City, Missouri, 64111

  • GSK Investigational Site

    Las Vegas, Nevada, 89103

  • GSK Investigational Site

    Lexington, Kentucky, 40536-0284

  • GSK Investigational Site

    Little Rock, Arkansas, 72205

  • GSK Investigational Site

    Los Angeles, California, 90033

  • GSK Investigational Site

    Los Angeles, California, 90073

  • GSK Investigational Site

    Louisville, Kentucky, 40202

  • GSK Investigational Site

    Maitland, Florida, 32751

  • GSK Investigational Site

    Mesa, Arizona, 85201

  • GSK Investigational Site

    Milwaukee, Wisconsin, 53215

  • GSK Investigational Site

    Minneapolis, Minnesota, 55422

  • GSK Investigational Site

    Minneapolis, Minnesota, 55454

  • GSK Investigational Site

    New York, New York, 10016

  • GSK Investigational Site

    Newport Beach, California, 92660

  • GSK Investigational Site

    Northport, Alabama, 35476

  • GSK Investigational Site

    Ocala, Florida, 34471

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73104

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73112

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19107

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19140

  • GSK Investigational Site

    Phoenix, Arizona, 85006

  • GSK Investigational Site

    Plainview, New York, 11803

  • GSK Investigational Site

    Raleigh, North Carolina, 27607

  • GSK Investigational Site

    Richmond, Virginia, 23220

  • GSK Investigational Site

    Salt Lake City, Utah, 84107

  • GSK Investigational Site

    San Antonio, Texas, 78258

  • GSK Investigational Site

    Santa Monica, California, 90404

  • GSK Investigational Site

    Savannah, Georgia, 31405

  • GSK Investigational Site

    Scottsdale, Arizona, 85259

  • GSK Investigational Site

    Seattle, Washington, 98122-4358

  • GSK Investigational Site

    Sepuldeva, California, 91343

  • GSK Investigational Site

    Springfield, Illinois, 62702

  • GSK Investigational Site

    St Louis, Missouri, 63110

  • GSK Investigational Site

    Sun City, Arizona, 85351

  • GSK Investigational Site

    Tallahassee, Florida, 32308

  • GSK Investigational Site

    Tampa, Florida, 33609

  • GSK Investigational Site

    Traverse City, Michigan, 49684

  • GSK Investigational Site

    Tucson, Arizona, 85712

  • GSK Investigational Site

    Tuscaloosa, Alabama, 35406

  • GSK Investigational Site

    Washington D.C., District of Columbia, 20016

  • GSK Investigational Site

    Washington D.C., District of Columbia, 20037

  • GSK Investigational Site

    West Orange, New Jersey, 07052

  • GSK Investigational Site

    Wichita, Kansas, 67214

  • GSK Investigational Site

    Wichita Falls, Texas, 76301

Other trials in United States

Germany51 sites

  • GSK Investigational Site

    Alzenau in Unterfranken, Bavaria, 63755

  • GSK Investigational Site

    Bad Homburg, Hesse, 61348

  • GSK Investigational Site

    Baesweiler, North Rhine-Westphalia, 52499

  • GSK Investigational Site

    Bamberg, Bavaria, 96047

  • GSK Investigational Site

    Berlin, State of Berlin, 10117

  • GSK Investigational Site

    Berlin, State of Berlin, 10969

  • GSK Investigational Site

    Berlin, State of Berlin, 13353

  • GSK Investigational Site

    Bernau bei Berlin, Brandenburg, 16321

  • GSK Investigational Site

    Bernburg, Saxony-Anhalt, 06406

  • GSK Investigational Site

    Bochum, North Rhine-Westphalia, 44795

  • GSK Investigational Site

    Bochum, North Rhine-Westphalia, 44892

  • GSK Investigational Site

    Bückeburg, Lower Saxony, 31675

  • GSK Investigational Site

    Chemnitz, Saxony, 09111

  • GSK Investigational Site

    Cologne, North Rhine-Westphalia, 50672

  • GSK Investigational Site

    Cologne, North Rhine-Westphalia, 50767

  • GSK Investigational Site

    Essen, North Rhine-Westphalia, 45122

  • GSK Investigational Site

    Essen, North Rhine-Westphalia, 45138

  • GSK Investigational Site

    Flöha, Saxony, 09557

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 60594

  • GSK Investigational Site

    Fürth, Bavaria, 90762

  • GSK Investigational Site

    Giessen, Hesse, 35390

  • GSK Investigational Site

    Göttingen, Lower Saxony, 37075

  • GSK Investigational Site

    Halle, Saxony-Anhalt, 06118

  • GSK Investigational Site

    Hamburg, Free and Hanseatic City of Hamburg, 20249

  • GSK Investigational Site

    Hamburg, Free and Hanseatic City of Hamburg, 21029

  • GSK Investigational Site

    Hamburg, Free and Hanseatic City of Hamburg, 22083

  • GSK Investigational Site

    Hamburg, Free and Hanseatic City of Hamburg, 22523

  • GSK Investigational Site

    Hamburg, Free and Hanseatic City of Hamburg, 22527

  • GSK Investigational Site

    Hattingen, North Rhine-Westphalia, 45525

  • GSK Investigational Site

    Jena, Thuringia, 07743

  • GSK Investigational Site

    Jena-Lobeda, Thuringia, 07747

  • GSK Investigational Site

    Kiel, Schleswig-Holstein, 24105

  • GSK Investigational Site

    Leipzig, Saxony, 04105

  • GSK Investigational Site

    Limburgerhof, Rhineland-Palatinate, 67117

  • GSK Investigational Site

    Ludwigsfelde, Brandenburg, 14974

  • GSK Investigational Site

    Magdeburg, Saxony-Anhalt, 39104

  • GSK Investigational Site

    Magdeburg, Saxony-Anhalt, 39124

  • GSK Investigational Site

    Mönchengladbach, North Rhine-Westphalia, 41061

  • GSK Investigational Site

    Munich, Bavaria, 80331

  • GSK Investigational Site

    Münster, North Rhine-Westphalia, 48149

  • GSK Investigational Site

    Naumburg, Saxony-Anhalt, 06618

  • GSK Investigational Site

    Neuötting, Bavaria, 84524

  • GSK Investigational Site

    Osnabrück, Lower Saxony, 49074

  • GSK Investigational Site

    Radeberg, Saxony, 01465

  • GSK Investigational Site

    Singen, Baden-Wurttemberg, 78224

  • GSK Investigational Site

    Straubing, Bavaria, 94315

  • GSK Investigational Site

    Ulm, Baden-Wurttemberg, 89073

  • GSK Investigational Site

    Unterhaching, Bavaria, 82008

  • GSK Investigational Site

    Wismar, Mecklenburg-Vorpommern, 23966

  • GSK Investigational Site

    Wismar, Mecklenburg-Vorpommern, 23970

  • GSK Investigational Site

    Würzburg, Bavaria, 97070

Other trials in Germany

Russia9 sites

  • GSK Investigational Site

    Moscow, 107076

  • GSK Investigational Site

    Moscow, 111539

  • GSK Investigational Site

    Moscow, 117049

  • GSK Investigational Site

    Moscow, 119334

  • GSK Investigational Site

    Moscow, 125412

  • GSK Investigational Site

    Moscow, 127473

  • GSK Investigational Site

    Saint Petersburg, 193019

  • GSK Investigational Site

    Saint Petersburg, 197376

  • GSK Investigational Site

    Yekaterinburg, 620102

Other trials in Russia

South Korea4 sites

  • GSK Investigational Site

    Seoul, 110-744

  • GSK Investigational Site

    Seoul, 120-752

  • GSK Investigational Site

    Seoul, 138-736

  • GSK Investigational Site

    Seoul, 139-711

Other trials in South Korea

India3 sites

  • GSK Investigational Site

    Hyderabad, Andhra Pradesh, 500482

  • GSK Investigational Site

    Lucknow, 226003

  • GSK Investigational Site

    New Delhi

Other trials in India

Puerto Rico3 sites

  • GSK Investigational Site

    San German, Puerto Rico, 00683

  • GSK Investigational Site

    San Juan, Puerto Rico, 00918

  • GSK Investigational Site

    San Juan, Puerto Rico, 00936

Other trials in Puerto Rico

Ukraine3 sites

  • GSK Investigational Site

    Kharkiv, 61068

  • GSK Investigational Site

    Kyiv, 02660

  • GSK Investigational Site

    Lviv, 79021

Other trials in Ukraine

Brazil2 sites

  • GSK Investigational Site

    Campinas, São Paulo, 13083-970

  • GSK Investigational Site

    Curitiba, Paraná, 80069-900

Other trials in Brazil

Chile2 sites

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 7571831

  • GSK Investigational Site

    Santiago, Región Metro de Santiago

Other trials in Chile

Argentina1 site

  • GSK Investigational Site

    Capital Federal, Buenos Aires, 1181

Other trials in Argentina

About this study

Official title: A Multicenter, Double-Blind, Randomized, Parallel-group Evaluation of LAMICTAL Extended-release Adjunctive Therapy in Subjects With Partial Seizures

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.

Being tested
LAMICTAL extended-release
Keywords
partial seizures, Epilepsy, antiepileptic drugs, anticonvulsants, LAMICTAL, seizures, lamotrigine
Medical subject headings
Epilepsy, Epilepsies, Partial, Seizures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LAMICTAL extended-releaseDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The efficacy of LAMICTAL extended-release therapy will be measured by the percentage change from Baseline in partial seizure frequency during the double-blind treatment phase.

    Measured: 24 Weeks

Secondary outcomes (1)

  1. Reduction in partial seizure frequency during portions of double-blind phase (=25%,=50%,=75%,100%). Time to 50% reduction in partial seizure frequency. Adverse events. Weight change. Health outcomes questionnaires. Population Pharmacokinetics

    Measured: 24 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2005 (estimated)
  2. Study startOct 2004
  3. Primary completionJul 2007
  4. Study completionJul 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
244 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00113165
Sponsor's protocol ID
LAM100034
Status last verified
Dec 2016
First submitted
6 Jun 2005
Last updated
5 Dec 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

  • Naritoku DK, Warnock CR, Messenheimer JA, Borgohain R, Evers S, Guekht AB, Karlov VA, Lee BI, Pohl LR. Lamotrigine extended-release as adjunctive therapy for partial seizures. Neurology. 2007 Oct 16;69(16):1610-8. doi: 10.1212/01.wnl.0000277698.33743.8b.

    PubMed 17938371

  • van Dijkman SC, de Jager NCB, Rauwe WM, Danhof M, Della Pasqua O. Effect of Age-Related Factors on the Pharmacokinetics of Lamotrigine and Potential Implications for Maintenance Dose Optimisation in Future Clinical Trials. Clin Pharmacokinet. 2018 Aug;57(8):1039-1053. doi: 10.1007/s40262-017-0614-5.

    PubMed 29363050

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing LAMICTAL extended-release in people with Epilepsy and Epilepsy, Partial, run by GlaxoSmithKline at 148 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 148 sites in United States, Germany, Russia, South Korea, India and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The efficacy of LAMICTAL extended-release therapy will be measured by the percentage change from Baseline in partial seizure frequency during the double-blind treatment phase. (time frame: 24 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00113165, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2016.

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