Study Evaluating LAMICTAL Extended-Release Therapy Added To Current Seizure Treatments In Patients With Primary Generalized Tonic-Clonic Seizures (PGTC) Seizures

NCT00104416 | Completed Phase 3 Results

• 1 other identifier: LAM100036
• Study Type: interventional
• Target: 153
• Locations: 11 countries
• Sites: 146

Brief Summary

This study is being conducted to compare the efficacy and safety of LAMICTAL (lamotrigine) extended-release with placebo in the treatment of Primary Generalized Tonic-Clonic (PGTC) 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.

Conditions

Epilepsy, Tonic-Clonic

Keywords

antiepileptic drugs; seizures; primary generalized tonic-clonic seizures; Epilepsy; lamotrigine; anticonvulsants; LAMICTAL

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline in Weekly Primary Generalized Tonic-clonic (PGTC) Seizure Frequency During the Entire Double-Blind Treatment Phase

  Percent change from baseline is calculated as the number of seizures by week during the Double-Blind Treatment Phase (Treatment Week 1 up to Week 19) compared to the number of seizures per week during the Baseline Phase (Baseline Week 1 up to Week 8). A positive number equals a reduction in seizure frequency. PGTC seizures are more commonly known as gran mal seizures.

  Baseline through end of Double-Blind Treatment Phase (up to Week 19)

Secondary Outcomes (16)

• Number of Participants With >=25%, >=50%, >=75%, or 100% Reduction in PGTC Seizure Frequency During the Entire Double-Blind (DB)Treatment Phase (TP), the Escalation Phase, the Maintenance Phase, and the Last 8 Weeks of the Maintenance Phase

  Entire DB Treatment Phase (Treatment Week 1 up to Week 19), Escalation Phase (Treatment Week 1 up to Week 7), Maintenance Phase (Treatment Week 8 up to Week 19), and the last 8 weeks of the Maintenance Phase (Treatment Week 12 up to Week 19)

• Percent Change From Baseline in PGTC Seizure Frequency During the Escalation Phase, the Maintenance Phase, and During the Last 8 Weeks of the Maintenance Phase of the Double-Blind Treatment Phase

  Escalation Phase (Treatment Week 1 up to Week 7), Maintenance Phase (Treatment Week 8 up to Week 19), and the last 8 weeks of the Maintenance Phase (Week 12 up to Week 19)

• Number of Participants With the Indicated Time to >=50% Reduction in Seizure Frequency in the Double-Blind Treatment Phase

  Baseline through end of Double-Blind Treatment Phase (up to Week 19)

• Change From Baseline in Body Weight at Week 19 of the Double-Blind Treatment Phase

  Baseline and Week 19 (or last on-study measurement in Double-Blind Treatment Phase)

• Number of Participants With Improved Clinical Status on the Investigator's Global Assessment in the Double-Blind Treatment Phase

  Week 19 (or last on-study assessment in Double-Blind Treatment Phase)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

lamotrigine (LAMICTAL) extended-relesase

EXPERIMENTAL

Drug: lamotrigine (LAMICTAL) extended-release

Interventions

lamotrigine (LAMICTAL) extended-release DRUG

Primary experimental dosage form

lamotrigine (LAMICTAL) extended-relesase

Placebo DRUG

Placebo control

Placebo

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Is ≥13 years of age (male or female).
• Has a confident diagnosis of epilepsy with PGTC seizures for more than 24 weeks prior to the Baseline Phase.
• Has electroencephalogram (EEG) evidence of either spike-and-wave discharges consistent with PGTC, or at least 2 EEGs with no indication of focal abnormalities. The EEG may be historical or prospective. Investigators may use a historical EEG as long as there is appropriate documentation.
• Has a documented history of PGTC seizures with or without other generalized seizure type(s) with no focal onset, and at least 1 PGTC seizure during the eight consecutive weeks (i.e., 56 consecutive days) prior to starting the 8-week Baseline Phase.
• Has at least 3 PGTC seizures occurring anytime during an 8-week (i.e., 56 days) prospective Baseline Phase.
• NOTE: With authorization from GSK, a maximum of four weeks (i.e., 28 days) of historical seizure data may replace up to four weeks (i.e., 28 days) of the prospective Baseline Phase for subjects providing reliable documentation of the following:
• complete daily seizure diary that includes the number of seizures experienced each day along with the exact classification of each seizure type for consecutive days prior to the prospective Baseline Phase
• stability of prescribed dosages of background antiepileptic drugs (AEDs)
• compliance with background AEDs.
• All subjects permitted to use historical seizure data must complete a minimum of four weeks (i.e., 28 days) of the prospective Baseline Phase. The historical Baseline Phase and the prospective Baseline Phase must equal 56 consecutive days.
• Is currently treated with a stable regimen of one or two AED(s) for at least four weeks prior to starting the Baseline Phase (historical or prospective).
• NOTE: Benzodiazepines used chronically will be considered to be concurrent AEDs.
• NOTE: Subjects with surgically implanted vagal nerve stimulators (VNS) will be allowed to enter the study provided that all of the following conditions are met:
• VNS has been in place for at least 24 weeks prior to the Baseline Phase.
• The settings must remain the same for at least 28 days prior to the Baseline Phase.

You may not qualify if:

• Has a history of partial seizures or interictal expression of partial seizures as evidenced by EEG NOTE: EEG may be historical or prospective.
• Has had status epilepticus within the 24 weeks prior to, or during, the Baseline Phase.
• Is taking three or more background AEDs chronically.
• Has Lennox-Gastaut syndrome.
• Is currently using or has previously used lamotrigine.
• Is currently taking felbamate.
• Is abusing alcohol and/or other substance(s).
• Has taken an investigational drug within the previous 30 days or plans to take an investigational drug anytime during the study.
• Is receiving chronic treatment with any medication that could influence seizure control. NOTE: Use of benzodiazepines is allowed.
• Is currently following the ketogenic diet.
• Is planning surgery to control seizures during the study.
• Is suffering from acute or progressive neurological disease, severe psychiatric disease, or severe mental abnormality that are likely to interfere with the objectives of the study.
• Has any clinically significant cardiac, renal, hepatic condition, or a condition that affects the absorption, distribution, metabolism or excretion of drugs.
• Is pregnant, breastfeeding, or planning to become pregnant during the study or within the three weeks after the last dose of study drug.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (146)

GSK Investigational Site

Anniston, Alabama, 36207, United States

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GSK Investigational Site

Birmingham, Alabama, 35294-0021, United States

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GSK Investigational Site

Northport, Alabama, 35476, United States

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GSK Investigational Site

Tuscaloosa, Alabama, 35406, United States

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Phoenix, Arizona, 85006, United States

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GSK Investigational Site

Phoenix, Arizona, 85013, United States

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Scottsdale, Arizona, 85259, United States

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Tucson, Arizona, 85712, United States

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GSK Investigational Site

Little Rock, Arkansas, 72205, United States

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GSK Investigational Site

Los Angeles, California, 90033, United States

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GSK Investigational Site

Los Angeles, California, 90073, United States

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GSK Investigational Site

Newport Beach, California, 92660, United States

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GSK Investigational Site

Santa Monica, California, 90404, United States

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GSK Investigational Site

Sepuldeva, California, 91343, United States

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GSK Investigational Site

Washington D.C., District of Columbia, 20037, United States

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GSK Investigational Site

Hollywood, Florida, 33021, United States

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GSK Investigational Site

Maitland, Florida, 32751, United States

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Ocala, Florida, 34471, United States

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Atlanta, Georgia, 30342, United States

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Augusta, Georgia, 30912-3200, United States

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GSK Investigational Site

Marietta, Georgia, 30060, United States

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GSK Investigational Site

Savannah, Georgia, 31405, United States

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GSK Investigational Site

Suwanee, Georgia, 30024, United States

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GSK Investigational Site

Chicago, Illinois, 60612, United States

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GSK Investigational Site

Flossmoor, Illinois, 60422, United States

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GSK Investigational Site

Springfield, Illinois, 62702, United States

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GSK Investigational Site

Des Moines, Iowa, 50309-1426, United States

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Wichita, Kansas, 67214, United States

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Crestview Hills, Kentucky, 41017, United States

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Louisville, Kentucky, 40202, United States

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Lafayette, Louisiana, 70503, United States

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Boston, Massachusetts, 02118, United States

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Detroit, Michigan, 48202, United States

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Grand Rapids, Michigan, 49525, United States

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Traverse City, Michigan, 49684, United States

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Minneapolis, Minnesota, 55422, United States

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GSK Investigational Site

Minneapolis, Minnesota, 55455, United States

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GSK Investigational Site

Chesterfield, Missouri, 63017, United States

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Kansas City, Missouri, 64111, United States

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Las Vegas, Nevada, 89106, United States

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Edison, New Jersey, 08818, United States

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GSK Investigational Site

West Orange, New Jersey, 07052, United States

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Amherst, New York, 14226, United States

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New York, New York, 10016, United States

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Asheville, North Carolina, 28801, United States

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Greenville, North Carolina, 27834, United States

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Raleigh, North Carolina, 27607, United States

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Columbus, Ohio, 43210-1250, United States

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Oklahoma City, Oklahoma, 73104, United States

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GSK Investigational Site

Oklahoma City, Oklahoma, 73112, United States

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Philadelphia, Pennsylvania, 19107, United States

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Philadelphia, Pennsylvania, 19140, United States

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Pittsburgh, Pennsylvania, 15215, United States

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Germantown, Tennessee, 38138, United States

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Dallas, Texas, 75230, United States

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Galveston, Texas, 77555, United States

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Houston, Texas, 77005, United States

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San Antonio, Texas, 78258, United States

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Wichita Falls, Texas, 76301, United States

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Salt Lake City, Utah, 84107, United States

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Burlington, Vermont, 05401, United States

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Richmond, Virginia, 23220, United States

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Madison, Wisconsin, 53715, United States

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Milwaukee, Wisconsin, 53215, United States

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GSK Investigational Site

Capital Federal, Buenos Aires, 1181, Argentina

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Buenos Aires, 1425, Argentina

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Buenos Aires, C1221ADC, Argentina

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Curitiba, Paraná, 80069-900, Brazil

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Campinas, São Paulo, 13083-970, Brazil

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São Paulo, São Paulo, 05403-900, Brazil

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Santiago, Región Metro de Santiago, 7571831, Chile

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Santiago, Región Metro de Santiago, Chile

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Singen, Baden-Wurttemberg, 78224, Germany

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Ulm, Baden-Wurttemberg, 89073, Germany

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Alzenau in Unterfranken, Bavaria, 63755, Germany

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Bamberg, Bavaria, 96047, Germany

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Fürth, Bavaria, 90762, Germany

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Munich, Bavaria, 80331, Germany

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Neuötting, Bavaria, 84524, Germany

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Straubing, Bavaria, 94315, Germany

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Unterhaching, Bavaria, 82008, Germany

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Würzburg, Bavaria, 97070, Germany

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Bernau bei Berlin, Brandenburg, 16321, Germany

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GSK Investigational Site

Ludwigsfelde, Brandenburg, 14974, Germany

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Hamburg, Hamburg, 20249, Germany

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Hamburg, Hamburg, 21029, Germany

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Hamburg, Hamburg, 22083, Germany

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Hamburg, Hamburg, 22523, Germany

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Hamburg, Hamburg, 22527, Germany

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Bad Homburg, Hesse, 61348, Germany

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Frankfurt am Main, Hesse, 60594, Germany

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Bückeburg, Lower Saxony, 31675, Germany

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Göttingen, Lower Saxony, 37075, Germany

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Osnabrück, Lower Saxony, 49074, Germany

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Wismar, Mecklenburg-Vorpommern, 23966, Germany

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Wismar, Mecklenburg-Vorpommern, 23970, Germany

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Baesweiler, North Rhine-Westphalia, 52499, Germany

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Bochum, North Rhine-Westphalia, 44795, Germany

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Bochum, North Rhine-Westphalia, 44892, Germany

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Cologne, North Rhine-Westphalia, 50767, Germany

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Essen, North Rhine-Westphalia, 45122, Germany

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Essen, North Rhine-Westphalia, 45138, Germany

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Hattingen, North Rhine-Westphalia, 45525, Germany

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Mönchengladbach, North Rhine-Westphalia, 41061, Germany

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Münster, North Rhine-Westphalia, 48149, Germany

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Limburgerhof, Rhineland-Palatinate, 67117, Germany

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Flöha, Saxony, 09557, Germany

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Leipzig, Saxony, 04105, Germany

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Leipzig, Saxony, 04157, Germany

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Bernburg, Saxony-Anhalt, 06406, Germany

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Halle, Saxony-Anhalt, 06118, Germany

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Köthen, Saxony-Anhalt, 06366, Germany

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Magdeburg, Saxony-Anhalt, 39104, Germany

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Magdeburg, Saxony-Anhalt, 39124, Germany

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Naumburg, Saxony-Anhalt, 06618, Germany

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Kiel, Schleswig-Holstein, 24105, Germany

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Berlin, State of Berlin, 10117, Germany

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Berlin, State of Berlin, 10969, Germany

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Berlin, State of Berlin, 13353, Germany

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Jena, Thuringia, 07743, Germany

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Hyderabad, Andhra Pradesh, 500482, India

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Lucknow, 226003, India

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New Delhi, India

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Kubang Kerian, 16150, Malaysia

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San Germán, Puerto Rico, 00683, Puerto Rico

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San Juan, Puerto Rico, 00918, Puerto Rico

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San Juan, Puerto Rico, 00936, Puerto Rico

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Moscow, 105066, Russia

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Moscow, 107076, Russia

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GSK Investigational Site

Moscow, 111539, Russia

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Moscow, 117049, Russia

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Moscow, 119334, Russia

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Moscow, 125412, Russia

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Saint Petersburg, 193019, Russia

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Saint Petersburg, 194291, Russia

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Samara, 443095, Russia

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GSK Investigational Site

St'Petersburg, 197136, Russia

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GSK Investigational Site

Yekaterinburg, 620102, Russia

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GSK Investigational Site

Daejeon, 301-721, South Korea

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Seoul, 110-744, South Korea

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GSK Investigational Site

Seoul, 120-752, South Korea

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GSK Investigational Site

Seoul, 135-710, South Korea

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GSK Investigational Site

Seoul, 139-711, South Korea

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Kharkiv, 61068, Ukraine

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Kyiv, 02660, Ukraine

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GSK Investigational Site

Lviv, 79021, Ukraine

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Related Publications (1)

• Biton V, Di Memmo J, Shukla R, Lee YY, Poverennova I, Demchenko V, Saiers J, Adams B, Hammer A, Vuong A, Messenheimer J. Adjunctive lamotrigine XR for primary generalized tonic-clonic seizures in a randomized, placebo-controlled study. Epilepsy Behav. 2010 Nov;19(3):352-8. doi: 10.1016/j.yebeh.2010.07.022. Epub 2010 Oct 30.

  PMID: 20937567 DERIVED

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Epilepsy, Tonic-Clonic; Seizures; Epilepsy

Interventions

Lamotrigine

Condition Hierarchy (Ancestors)

Epilepsy, Generalized; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Triazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2005
• First Posted: March 1, 2005
• Study Start: December 1, 2004
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: January 2, 2017
• Results First Posted: May 18, 2010

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share

Locations

BR (3); CL (2); IN (3); US (64); PR (3); DE (48); RU (11); MY (1); AR (3); KR (5); UA (3)