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

NCT ID: NCT00104416

Last Updated: 2017-01-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 153 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-12-31
• Study Completion Date: 2008-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo control

lamotrigine (LAMICTAL) extended-relesase

Group Type: EXPERIMENTAL

lamotrigine (LAMICTAL) extended-release

Intervention Type: DRUG

Primary experimental dosage form

Interventions

lamotrigine (LAMICTAL) extended-release

Primary experimental dosage form

Intervention Type: DRUG

Placebo

Placebo control

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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:

1. 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

2. stability of prescribed dosages of background antiepileptic drugs (AEDs)

3. 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:

1. VNS has been in place for at least 24 weeks prior to the Baseline Phase.

2. The settings must remain the same for at least 28 days prior to the Baseline Phase.

3. The settings must remain the same during the Baseline, Escalation, Maintenance and Transition Phases.

4. The battery is expected to last for the duration of the study.

5. 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:

1. 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).

2. 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Anniston, Alabama, United States

GSK Investigational Site

Birmingham, Alabama, United States

GSK Investigational Site

Northport, Alabama, United States

GSK Investigational Site

Tuscaloosa, Alabama, United States

GSK Investigational Site

Phoenix, Arizona, United States

GSK Investigational Site

Phoenix, Arizona, United States

GSK Investigational Site

Scottsdale, Arizona, United States

GSK Investigational Site

Tucson, Arizona, United States

GSK Investigational Site

Little Rock, Arkansas, United States

GSK Investigational Site

Los Angeles, California, United States

GSK Investigational Site

Los Angeles, California, United States

GSK Investigational Site

Newport Beach, California, United States

GSK Investigational Site

Santa Monica, California, United States

GSK Investigational Site

Sepuldeva, California, United States

GSK Investigational Site

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

GSK Investigational Site

Hollywood, Florida, United States

GSK Investigational Site

Maitland, Florida, United States

GSK Investigational Site

Ocala, Florida, United States

GSK Investigational Site

Atlanta, Georgia, United States

GSK Investigational Site

Augusta, Georgia, United States

GSK Investigational Site

Marietta, Georgia, United States

GSK Investigational Site

Savannah, Georgia, United States

GSK Investigational Site

Suwanee, Georgia, United States

GSK Investigational Site

Chicago, Illinois, United States

GSK Investigational Site

Flossmoor, Illinois, United States

GSK Investigational Site

Springfield, Illinois, United States

GSK Investigational Site

Des Moines, Iowa, United States

GSK Investigational Site

Wichita, Kansas, United States

GSK Investigational Site

Crestview Hills, Kentucky, United States

GSK Investigational Site

Louisville, Kentucky, United States

GSK Investigational Site

Lafayette, Louisiana, United States

GSK Investigational Site

Boston, Massachusetts, United States

GSK Investigational Site

Detroit, Michigan, United States

GSK Investigational Site

Grand Rapids, Michigan, United States

GSK Investigational Site

Traverse City, Michigan, United States

GSK Investigational Site

Minneapolis, Minnesota, United States

GSK Investigational Site

Minneapolis, Minnesota, United States

GSK Investigational Site

Chesterfield, Missouri, United States

GSK Investigational Site

Kansas City, Missouri, United States

GSK Investigational Site

Las Vegas, Nevada, United States

GSK Investigational Site

Edison, New Jersey, United States

GSK Investigational Site

West Orange, New Jersey, United States

GSK Investigational Site

Amherst, New York, United States

GSK Investigational Site

New York, New York, United States

GSK Investigational Site

Asheville, North Carolina, United States

GSK Investigational Site

Greenville, North Carolina, United States

GSK Investigational Site

Raleigh, North Carolina, United States

GSK Investigational Site

Columbus, Ohio, United States

GSK Investigational Site

Oklahoma City, Oklahoma, United States

GSK Investigational Site

Oklahoma City, Oklahoma, United States

GSK Investigational Site

Philadelphia, Pennsylvania, United States

GSK Investigational Site

Philadelphia, Pennsylvania, United States

GSK Investigational Site

Pittsburgh, Pennsylvania, United States

GSK Investigational Site

Germantown, Tennessee, United States

GSK Investigational Site

Dallas, Texas, United States

GSK Investigational Site

Galveston, Texas, United States

GSK Investigational Site

Houston, Texas, United States

GSK Investigational Site

San Antonio, Texas, United States

GSK Investigational Site

Wichita Falls, Texas, United States

GSK Investigational Site

Salt Lake City, Utah, United States

GSK Investigational Site

Burlington, Vermont, United States

GSK Investigational Site

Richmond, Virginia, United States

GSK Investigational Site

Madison, Wisconsin, United States

GSK Investigational Site

Milwaukee, Wisconsin, United States

GSK Investigational Site

Capital Federal, Buenos Aires, Argentina

GSK Investigational Site

Buenos Aires, , Argentina

GSK Investigational Site

Buenos Aires, , Argentina

GSK Investigational Site

Curitiba, Paraná, Brazil

GSK Investigational Site

Campinas, São Paulo, Brazil

GSK Investigational Site

São Paulo, São Paulo, Brazil

GSK Investigational Site

Santiago, Región Metro de Santiago, Chile

GSK Investigational Site

Santiago, Región Metro de Santiago, Chile

GSK Investigational Site

Singen, Baden-Wurttemberg, Germany

GSK Investigational Site

Ulm, Baden-Wurttemberg, Germany

GSK Investigational Site

Alzenau in Unterfranken, Bavaria, Germany

GSK Investigational Site

Bamberg, Bavaria, Germany

GSK Investigational Site

Fürth, Bavaria, Germany

GSK Investigational Site

Munich, Bavaria, Germany

GSK Investigational Site

Neuötting, Bavaria, Germany

GSK Investigational Site

Straubing, Bavaria, Germany

GSK Investigational Site

Unterhaching, Bavaria, Germany

GSK Investigational Site

Würzburg, Bavaria, Germany

GSK Investigational Site

Bernau bei Berlin, Brandenburg, Germany

GSK Investigational Site

Ludwigsfelde, Brandenburg, Germany

GSK Investigational Site

Hamburg, City state of Hamburg, Germany

GSK Investigational Site

Hamburg, City state of Hamburg, Germany

GSK Investigational Site

Hamburg, City state of Hamburg, Germany

GSK Investigational Site

Hamburg, City state of Hamburg, Germany

GSK Investigational Site

Hamburg, City state of Hamburg, Germany

GSK Investigational Site

Bad Homburg, Hesse, Germany

GSK Investigational Site

Frankfurt am Main, Hesse, Germany

GSK Investigational Site

Bückeburg, Lower Saxony, Germany

GSK Investigational Site

Göttingen, Lower Saxony, Germany

GSK Investigational Site

Osnabrück, Lower Saxony, Germany

GSK Investigational Site

Wismar, Mecklenburg-Vorpommern, Germany

GSK Investigational Site

Wismar, Mecklenburg-Vorpommern, Germany

GSK Investigational Site

Baesweiler, North Rhine-Westphalia, Germany

GSK Investigational Site

Bochum, North Rhine-Westphalia, Germany

GSK Investigational Site

Bochum, North Rhine-Westphalia, Germany

GSK Investigational Site

Cologne, North Rhine-Westphalia, Germany

GSK Investigational Site

Essen, North Rhine-Westphalia, Germany

GSK Investigational Site

Essen, North Rhine-Westphalia, Germany

GSK Investigational Site

Hattingen, North Rhine-Westphalia, Germany

GSK Investigational Site

Mönchengladbach, North Rhine-Westphalia, Germany

GSK Investigational Site

Münster, North Rhine-Westphalia, Germany

GSK Investigational Site

Limburgerhof, Rhineland-Palatinate, Germany

GSK Investigational Site

Flöha, Saxony, Germany

GSK Investigational Site

Leipzig, Saxony, Germany

GSK Investigational Site

Leipzig, Saxony, Germany

GSK Investigational Site

Bernburg, Saxony-Anhalt, Germany

GSK Investigational Site

Halle, Saxony-Anhalt, Germany

GSK Investigational Site

Köthen, Saxony-Anhalt, Germany

GSK Investigational Site

Magdeburg, Saxony-Anhalt, Germany

GSK Investigational Site

Magdeburg, Saxony-Anhalt, Germany

GSK Investigational Site

Naumburg, Saxony-Anhalt, Germany

GSK Investigational Site

Kiel, Schleswig-Holstein, Germany

GSK Investigational Site

Berlin, State of Berlin, Germany

GSK Investigational Site

Berlin, State of Berlin, Germany

GSK Investigational Site

Berlin, State of Berlin, Germany

GSK Investigational Site

Jena, Thuringia, Germany

GSK Investigational Site

Hyderabad, Andhra Pradesh, , India

GSK Investigational Site

Lucknow, , India

GSK Investigational Site

New Delhi, , India

GSK Investigational Site

Kubang Kerian, , Malaysia

GSK Investigational Site

San Germán, Puerto Rico, Puerto Rico

GSK Investigational Site

San Juan, Puerto Rico, Puerto Rico

GSK Investigational Site

San Juan, Puerto Rico, Puerto Rico

GSK Investigational Site

Moscow, , Russia

GSK Investigational Site

Moscow, , Russia

GSK Investigational Site

Moscow, , Russia

GSK Investigational Site

Moscow, , Russia

GSK Investigational Site

Moscow, , Russia

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Moscow, , Russia

GSK Investigational Site

Saint Petersburg, , Russia

GSK Investigational Site

Saint Petersburg, , Russia

GSK Investigational Site

Samara, , Russia

GSK Investigational Site

St'Petersburg, , Russia

GSK Investigational Site

Yekaterinburg, , Russia

GSK Investigational Site

Daejeon, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Kharkiv, , Ukraine

GSK Investigational Site

Kyiv, , Ukraine

GSK Investigational Site

Lviv, , Ukraine

Countries

United States; Argentina; Brazil; Chile; Germany; India; Malaysia; Puerto Rico; Russia; South Korea; Ukraine

References

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.

Reference Type: DERIVED

PMID: 20937567 (View on PubMed)

Study Documents

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

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

Other Identifiers

LAM100036

Identifier Type: -

Identifier Source: org_study_id