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Epilepsy, Tonic-ClonicPhase 3NCT00104416

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

A Phase 3 study testing lamotrigine (LAMICTAL) extended-release in people with Epilepsy, Tonic-Clonic, run by GlaxoSmithKline at 146 sites in 11 countries.

Completed

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

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 13 years and older
Conditions the study is for
Epilepsy, Tonic-Clonic
What is being tested?
lamotrigine (LAMICTAL) extended-release
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
153 participants
Where
146 sitesin 11 countries
Study dates
Dec 2004to Jul 2008
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • 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: When a historical baseline is used, the same time period cannot count for documentation of inclusion criteria 4 and 5. Additionally, innumerable seizure activity will not count towards the number of seizures required for randomization.
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  • 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.
  • The settings must remain the same during the Baseline, Escalation, Maintenance and Transition Phases.
  • The battery is expected to last for the duration of the study.
  • VNS is counted as a "concurrent AED."
  • Is able and willing to maintain an accurate and complete daily written seizure diary, or has a parent/caregiver who is able and willing to maintain an accurate and complete daily written seizure diary for the entire duration of the study.
  • Is able to comply with dosing of study drugs, background AEDs and all study procedures.
  • Has given written informed consent, or has a parent/legally authorized representative who has given written informed consent, prior to the performance of any study assessments.
  • If female, and of childbearing potential, must be using an acceptable form of birth control, to include one of the following:
  • Complete abstinence from intercourse for two weeks before exposure to the study drug, throughout the clinical trial, and for a period after the trial to account for elimination of the drug (a minimum of 3 weeks).
  • Consistent and correct use of one of the following methods of birth control:
  • Male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject
  • Implants of levonorgestrel
  • Injectable progestogen
  • Oral contraceptive (either combined, with at least 50mcg estrogen for women on enzyme-induced AEDs, or progestogen only)
  • Any intrauterine device (IUD) with a documented failure rate of less than 1% per year
  • Double barrier method consisting of spermicide plus a mechanical barrier (e.g., spermicide plus a male condom or a female diaphragm).
  • NOTE: Women who have had a hysterectomy, tubal ligation, or are post-menopausal are considered to be of non-childbearing potential.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

146 sites in 11 countries.

146 sites in 11 countries

United States64 sites

  • GSK Investigational Site

    Amherst, New York, 14226

  • GSK Investigational Site

    Anniston, Alabama, 36207

  • GSK Investigational Site

    Asheville, North Carolina, 28801

  • GSK Investigational Site

    Atlanta, Georgia, 30342

  • GSK Investigational Site

    Augusta, Georgia, 30912-3200

  • GSK Investigational Site

    Birmingham, Alabama, 35294-0021

  • GSK Investigational Site

    Boston, Massachusetts, 02118

  • GSK Investigational Site

    Burlington, Vermont, 05401

  • GSK Investigational Site

    Chesterfield, Missouri, 63017

  • 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

    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

    Germantown, Tennessee, 38138

  • GSK Investigational Site

    Grand Rapids, Michigan, 49525

  • 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

    Lafayette, Louisiana, 70503

  • GSK Investigational Site

    Las Vegas, Nevada, 89106

  • 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

    Madison, Wisconsin, 53715

  • GSK Investigational Site

    Maitland, Florida, 32751

  • GSK Investigational Site

    Marietta, Georgia, 30060

  • GSK Investigational Site

    Milwaukee, Wisconsin, 53215

  • GSK Investigational Site

    Minneapolis, Minnesota, 55422

  • GSK Investigational Site

    Minneapolis, Minnesota, 55455

  • 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

    Phoenix, Arizona, 85013

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15215

  • 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

    Sepuldeva, California, 91343

  • GSK Investigational Site

    Springfield, Illinois, 62702

  • GSK Investigational Site

    Suwanee, Georgia, 30024

  • 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, 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

Germany48 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

    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

    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

    Kiel, Schleswig-Holstein, 24105

  • GSK Investigational Site

    Köthen, Saxony-Anhalt, 06366

  • GSK Investigational Site

    Leipzig, Saxony, 04105

  • GSK Investigational Site

    Leipzig, Saxony, 04157

  • 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

    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

Russia11 sites

  • GSK Investigational Site

    Moscow, 105066

  • 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

    Saint Petersburg, 193019

  • GSK Investigational Site

    Saint Petersburg, 194291

  • GSK Investigational Site

    Samara, 443095

  • GSK Investigational Site

    St'Petersburg, 197136

  • GSK Investigational Site

    Yekaterinburg, 620102

Other trials in Russia

South Korea5 sites

  • GSK Investigational Site

    Daejeon, 301-721

  • GSK Investigational Site

    Seoul, 110-744

  • GSK Investigational Site

    Seoul, 120-752

  • GSK Investigational Site

    Seoul, 135-710

  • GSK Investigational Site

    Seoul, 139-711

Other trials in South Korea

Argentina3 sites

  • GSK Investigational Site

    Buenos Aires, 1425

  • GSK Investigational Site

    Buenos Aires, C1221ADC

  • GSK Investigational Site

    Capital Federal, Buenos Aires, 1181

Other trials in Argentina

Brazil3 sites

  • GSK Investigational Site

    Campinas, São Paulo, 13083-970

  • GSK Investigational Site

    Curitiba, Paraná, 80069-900

  • GSK Investigational Site

    São Paulo, São Paulo, 05403-900

Other trials in Brazil

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

Chile2 sites

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 7571831

  • GSK Investigational Site

    Santiago, Región Metro de Santiago

Other trials in Chile

Malaysia1 site

  • GSK Investigational Site

    Kubang Kerian, 16150

Other trials in Malaysia

About this study

Official title: A Multicenter, Double-blind, Randomized, Parallel-group Evaluation of LAMICTAL Extended-Release Adjunctive Therapy in Patients With Primary Generalized Tonic-Clonic Seizures

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.

Being tested
lamotrigine (LAMICTAL) extended-release, Placebo
Keywords
antiepileptic drugs, seizures, primary generalized tonic-clonic seizures, Epilepsy, lamotrigine, anticonvulsants, LAMICTAL
Medical subject headings
Epilepsy, Tonic-Clonic, Seizures, Epilepsy

What participants receive

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

  • lamotrigine (LAMICTAL) extended-releaseDrug

    Primary experimental dosage form

  • PlaceboDrug

    Placebo control

Study groups in NCT00104416
Study groupRoleWhat they receive
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo
lamotrigine (LAMICTAL) extended-relesaseExperimentalNot described
Receives: Drug: lamotrigine (LAMICTAL) extended-release

What is being measured

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

  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.

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

Secondary outcomes (16)

  1. 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

    Change in seizure frequency was calculated as the average seizure frequency during each of the following: the Entire DB Treatment Phase (Treatment Week 1 up to Week 19); the Escalation Phase (Treatment Week 1 up to Week 7); the 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), minus the seizure frequency at Baseline.

    Measured: 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)

  2. 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

    Percent change from baseline is calculated as the number of seizures by week during the Escalation Phase (Treatment Week 1 up to Week 7), the Maintenance Phase (Treatment Week 8 up to Week 19), and during the last 8 weeks of the Maintenance Phase (Treatment Week 12 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.

    Measured: 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)

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

    50% reduction in seizure frequency is defined as the time at which a participant first achieved and maintained a >=50% reduction in seizure frequency following exposure to at least 1 week of study drug.

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

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

    Change from baseline in body weight is calculated as the Week 19 (or last on-study measurement in Double-Blind Treatment Phase) value minus the Baseline value.

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

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

    The investigators rated the participants' overall clinical status based on 7 clinical factors and an overall factor: seizure frequency, duration, and intensity; adverse experiences; social, intellectual, and motor functioning. Using a 7-point scale (marked deterioration [1], moderate deterioration [2], mild deterioration [3], no change [4], mild improvement [5], moderate improvement [6], or marked improvement [7]), the investigators assessed the participants' status compared to their condition prior to initiating study medication.

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

  6. Number of Participants With Improved Satisfaction With Seizure Control on the Subject Satisfaction Questionnaire in the Double-Blind Treatment Phase

    Participants were asked to rate their satisfaction with their seizure control compared to their seizure control prior to initiating study drug on a 7 point scale: marked deterioration (1), moderate deterioration (2), mild deterioration (3), no change (4), mild improvement (5), moderate improvement (6), or marked improvement (7).

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

  7. Percent Change From Baseline in Weekly PGTC Seizure Frequency During the Entire Continuation Phase (CP), the Transition Phase, the Open-Label Phase, and the Last 8 Weeks of the Open-Label Phase

    Percent change from baseline is calculated as the number of seizures by week during the entire CP (CP Week 1 up to Week 52), the Transition Phase (CP Week 1 up to Week 7), the Open-Label Phase (CP Week 8 up to Week 52), and the last 8 weeks of the Open-Label Phase (CP Week 45 up to Week 52) minus the number of seizures per week during the Baseline Phase (Baseline Week 1 through Week 8). A positive number equals a reduction in seizure frequency.

    Measured: Entire CP (CP Week 1 up to Week 52), the Transition Phase (CP Week 1 up to Week 7), the Open-Label Phase (CP Week 8 up to Week 52), and the last 8 weeks of the Open-Label Phase (CP Week 45 up to Week 52)

  8. Number of Participants With >=25%, >=50%, >=75%, or 100% Reduction or >=50% Increase From Baseline in Weekly PGTC Seizure Frequency for the Entire Continuation Phase, the Transition Phase, the Open-Label (OL) Phase, and the Last 8 Weeks of the OL Phase.

    Change in seizure frequency was calculated as the average seizure frequency during each of the following: the Entire CP (CP Week 1 up to Week 52); the Transition Phase (CP Week 1 up to Week 7); the Open-Label (OL) Phase (CP Week 8 up to Week 52); and the last 8 weeks of the Open Label Phase (CP Week 45 up to Week 52) minus the seizure frequency at Baseline. W, Week.

    Measured: Entire CP (CP Week 1 up to Week 52), the Transition Phase (CP Week 1 up to Week 7), the Open-Label Phase (CP Week 8 up to Week 52), and the last 8 weeks of the Open-Label Phase (CP Week 45 up to Week 52)

  9. Mean Change From Baseline in the Profile of Mood State (POMS) Mood Disturbance Total Score at Week 19 of the Double-Blind Treatment Phase

    The POMS is a self-administered 65-item questionnaire that evaluates the participants' perception of their mood state in 6 areas: tension-anxiety, depression-dejection, anger-hostility, vigor-activity, fatigue-inertia, and confusion-bewilderment. Items are rated on a 5-point Likert scale from 0 (not at all) to 4 (extremely), with higher scores indicating a more negative mood state. A total score (from 0 to 24) is obtained by summing the scores of the six domains.

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

  10. Mean Change From Baseline in the Center for Epidemiological Studies-Depression Scale (CES-D) Total Score at Week 19 of the Double-Blind Treatment Phase

    The 20-item CES-D questionnaire is self-administered and asks respondents to report the frequency to which the 20 events were experienced over the past week. A 4-point Likert scale is used and ranges from rarely or none of the time (0) to most or all of the time (3). The total score, a sum across the 20 items (ranging from 0 to 60), determines the extent to which a participant may be experiencing depression. Higher scores indicate a higher severity of depression.

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

  11. Mean Change From Baseline in the Neurological Disorders Depression Inventory-Epilepsy (NDDI-E) 6-Item Total Score at Week 19 of the Double-Blind Treatment Phase

    The NDDI-E is a self-reported questionnaire composed of 46 brief phrases/words to identify mood disorders across the spectrum of depression. It was developed to capture depressive moods that are co-morbid with the disease of epilepsy or its treatment as well as to measure the depressive state of the participant. All phrases are measured on a 4-point Likert scale of Never (1) to Always/often (4) and refer to the participants' mood over the past week. Scoring is comprised of a total mood score calculated by summing the scores of 6 specific items (from 6=never to 24=always or often).

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

  12. Mean Change From Baseline in the Quality of Life in Epilepsy-31-P (QOLIE-31P) Overall Score at Week 19 of the Double-Blind Treatment Phase

    The QOLIE-31 is a 31-item questionnaire that evaluates the participants' perception of his or her quality of life in 7 domains: seizure worry, emotional well being, energy/fatigue, cognitive functioning, medication effects, social functioning, and overall quality of life. Each domain (with scores ranging from 0 to 100) is summed and divided by the total number of questions that were answered. The overall score is derived by weighting and then summing up the seven domain scores.

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

  13. Mean Change From Baseline in the Adverse Experience Profile (AEP) Total Score at Week 19 of the Double-Blind Treatment Phase

    The AEP is a list of 19 items covering many possible side effects attributable to drug treatment. The participants respond by assessing how much each event has been a problem for them over the past 4 weeks (1=Never a Problem to 4=Always a Problem). Each individual item can be examined; an overall adverse events score is calculated as the sum of the scores across the 19 items. The AEP total score ranges from 19 to 76, with a higher score indicating a higher degree of adverse event severity.

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

  14. Mean Change From Baseline in the Seizure Severity Questionnaire (SSQ) Global Bother Score at Week 19 Double-Blind Treatment Phase

    The SSQ is a self-reported instrument developed to assess the severity of seizures and seizure symptoms. The scale consists of 10 major clinical features/symptoms of seizures that the participants rate on a 7-point Likert scale (ranging from very mild/helpful/no bother at all [1] to very severe/no help/bothersome [7]). The Global Bother Domain is the primary score used for the analysis of the SSQ and has scores ranging from 1 to 7.

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

  15. Mean Change From Baseline in the Epworth Sleepiness Scale (ESS) 8-Item Total Score at Week 19 of the Double-Blind Treatment Phase

    The ESS is an 8-item, self-administered questionnaire that measures excessive daytime sleepiness in adults. The instrument captures information on the extent to which the participant would be likely, or not, to fall asleep in certain situations. The stimulus question is: How likely are you to doze off or fall asleep in the following situations, in contrast to feeling just tired? Questions are answered on a 4-point scale (would never doze [0] to high chance of dozing [3]). The total score ranges from 0 to 24, where a higher score indicates a higher chance of dozing.

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

  16. Serum Concentrations and Population (POP) Pharmacokinetic Parameters for Lamotrigine

    Serum samples for participants on lamotrigine were analyzed with a validated analytical method based on solid phase extraction of serum followed by High-Performance Liquid Chromatography (HPLC) Mass Spectrometry (MS)/MS analysis. The lower limit of quantification (LLQ) for serum lamotrigine was 4 nanograms (ng)/milliliter (mL), using a 50 microliter (µL) aliquot of human serum with a higher limit of quantification (HLQ) of 4,000 ng/mL. PK data cannot be reported, as PK data from several different studies have been combined into one POP/PK analysis and cannot be separated by study.

    Measured: Blood samples drawn at Treatment Weeks 11, 15, and 19 (or last on-study measurement in Double-Blind Treatment Phase)

Timeline

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

  1. First posted1 Mar 2005 (estimated)
  2. Study startDec 2004
  3. Primary completionJul 2008
  4. Study completionJul 2008

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
Who is masked
Participant, Investigator
Enrolment
153 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00104416
Sponsor's protocol ID
LAM100036
Status last verified
Nov 2016
First submitted
28 Feb 2005
Last updated
2 Jan 2017
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

  • 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.

    PubMed 20937567

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing lamotrigine (LAMICTAL) extended-release in people with Epilepsy, Tonic-Clonic, run by GlaxoSmithKline at 146 sites in 11 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 32 inclusion and 14 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 2 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 146 sites in United States, Germany, Russia, South Korea, Argentina and 6 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 18 May 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percent Change From Baseline in Weekly Primary Generalized Tonic-clonic (PGTC) Seizure Frequency During the Entire Double-Blind Treatment Phase (time frame: Baseline through end of Double-Blind Treatment Phase (up to Week 19)). 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 NCT00104416, which also lists 1 linked publication.

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 2 Jan 2017.

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