Conversion To Monotherapy With Lamictal Extended Release Tablets For Treatment Of Partial Epilepsy

NCT ID: NCT00355082

Last Updated: 2017-01-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 226 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2008-11-30

Brief Summary

This study is being conducted to determine the effectiveness of a lower monotherapy dose of lamotrigine than that currently approved.

Detailed Description

The study consists of a Treatment phase, where efficacy is determined and a Continuation phase for extended safety information. The Continuation phase is open to all Treatment phase participants and those who did not qualify for treatment because of an insufficient number of seizures during the Baseline phase.

Conditions

Epilepsy, Partial

Study Design

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

Study Groups

lamotrigine 300

300 mg/day treatment

Group Type: EXPERIMENTAL

lamotrigine, 300 mg/day

Intervention Type: DRUG

300 mg/day

lamotrigine 250

250 mg/day treatment

Group Type: EXPERIMENTAL

lamotrigine, 250 mg/day

Intervention Type: DRUG

250 mg/day

Interventions

lamotrigine, 300 mg/day

300 mg/day

Intervention Type: DRUG

lamotrigine, 250 mg/day

250 mg/day

Intervention Type: DRUG

Other Intervention Names

lamotrigine

Eligibility Criteria

Inclusion Criteria

• Male or Female ≥13 years of age
• Have a confident diagnosis of epilepsy with partial seizures for at least 24 weeks prior to the Baseline Phase
• Have a documented history of partial seizures such that the investigator must judge that the subject is likely to have at least 4 partial seizures during the 8-week Baseline Phase.
• Have experienced at least 4 partial seizures (i.e., simple or complex partial seizures with or without secondary generalization) during an 8-week (i.e., 56 days) prospective Baseline Phase with at least one partial seizure occurring during each 4-week (i.e., 28-day) period.
• NOTE: With prior authorization from GlaxoSmithKline (GSK), retrospective data may take the place of up to the first 4 weeks (i.e., first 28 days) of the Baseline Phase for subjects providing reliable documentation of the following:

1. A complete daily seizure diary that includes the number, and type (i.e., simple or complex partial seizures with or without secondary generalization), of seizures experienced each day for up to 28 consecutive days immediately prior to the prospective Baseline Phase

2. Stability of prescribed dosages of background antiepileptic drug (AED)

3. Compliance with background AED

All subjects permitted to use retrospective baseline data must complete a minimum of four weeks (i.e., 28 days) of the prospective Baseline Phase. The retrospective plus the prospective Baseline Phases must equal the 56 consecutive days prior to the start of dosing with study drug.

• be currently receiving AED monotherapy treatment with a stable regimen of a non-enzyme inducing AED for at least four weeks prior to starting the Baseline Phase.
• be able and willing to maintain an accurate, complete, written daily seizure diary, or has a parent/caregiver who is able and willing to maintain and accurate, complete, written daily seizure diary for the entire duration of the study.
• be able to comply with the dosing of study drugs, background AED, and all study procedures.
• understand and sign written informed consent, or will have a parent or a legally authorized representative who has done so, prior to the performance of any study assessments
• if female, and of childbearing potential 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 2 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.

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.

NOTE: A pharmacokinetic interaction has been observed between lamotrigine (LTG) and estrogen-based oral contraceptives. Therefore, the use of hormonal therapy (e.g., for contraception or hormone replacement therapy) is not allowed.

Exclusion Criteria

• Exhibits any primary generalized seizures (e.g., absence, myoclonic primary generalized tonic-clonic seizures).
• Has had status epilepticus within the 24 weeks prior to, or during, the Baseline Phase.
• Is taking an enzyme-inducing AED (EIAED - e.g. carbamazepine, phenytoin, phenobarbital, primidone) or is taking more than 1 background AED.
• Is currently taking lamotrigine (LTG) or has previously had an adequate trial of LTG.
• Is currently taking felbamate
• Is using hormone therapy
• Is abusing alcohol and/or other substances
• 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 as specified in Section 8.1.2
• Is currently following the ketogenic diet.
• Is using vagal nerve stimulation
• Is planning surgery to control seizures during the study.
• Is pregnant, breastfeeding, or planning to become pregnant during the study or within the three weeks after the last dose of study drug.
• Is suffering from acute or progressive neurological disease, severe psychiatric disease or severe mental abnormality that is 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.

• 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

Alabaster, Alabama, United States

GSK Investigational Site

Litchfield Park, Arizona, United States

GSK Investigational Site

Mesa, Arizona, United States

GSK Investigational Site

Phoenix, Arizona, United States

GSK Investigational Site

Phoenix, Arizona, United States

GSK Investigational Site

Tucson, Arizona, United States

GSK Investigational Site

Tucson, Arizona, United States

GSK Investigational Site

Fayetteville, Arkansas, United States

GSK Investigational Site

Los Angeles, California, United States

GSK Investigational Site

Pasadena, California, United States

GSK Investigational Site

Santa Ana, California, United States

GSK Investigational Site

Santa Monica, California, United States

GSK Investigational Site

Danbury, Connecticut, United States

GSK Investigational Site

Fairfield, Connecticut, United States

GSK Investigational Site

Newark, Delaware, United States

GSK Investigational Site

Jacksonville, Florida, United States

GSK Investigational Site

Loxahatchee Groves, Florida, United States

GSK Investigational Site

Sunrise, Florida, United States

GSK Investigational Site

Tampa, Florida, United States

GSK Investigational Site

Atlanta, Georgia, United States

GSK Investigational Site

Atlanta, Georgia, United States

GSK Investigational Site

Decatur, Georgia, United States

GSK Investigational Site

Boise, Idaho, United States

GSK Investigational Site

Chicago, Illinois, United States

GSK Investigational Site

Chicago, Illinois, United States

GSK Investigational Site

Flossmoor, Illinois, United States

GSK Investigational Site

Urbana, Illinois, United States

GSK Investigational Site

Des Moines, Iowa, United States

GSK Investigational Site

Lexington, Kentucky, United States

GSK Investigational Site

Lexington, Kentucky, United States

GSK Investigational Site

Louisville, Kentucky, United States

GSK Investigational Site

New Orleans, Louisiana, United States

GSK Investigational Site

Bethesda, Maryland, United States

GSK Investigational Site

Glen Burnie, Maryland, United States

GSK Investigational Site

Pikesville, Maryland, United States

GSK Investigational Site

Springfield, Massachusetts, United States

GSK Investigational Site

Detroit, Michigan, United States

GSK Investigational Site

Minneapolis, Minnesota, United States

GSK Investigational Site

Saint Cloud, Minnesota, United States

GSK Investigational Site

Hattiesburg, Mississippi, United States

GSK Investigational Site

Kansas City, Missouri, United States

GSK Investigational Site

St Louis, Missouri, United States

GSK Investigational Site

St Louis, Missouri, United States

GSK Investigational Site

Henderson, Nevada, United States

GSK Investigational Site

Las Vegas, Nevada, United States

GSK Investigational Site

Las Vegas, Nevada, United States

GSK Investigational Site

Edison, New Jersey, United States

GSK Investigational Site

Vorhees, New Jersey, United States

GSK Investigational Site

Lawrence, New York, United States

GSK Investigational Site

Plainview, New York, United States

GSK Investigational Site

Syracuse, New York, United States

GSK Investigational Site

Asheville, North Carolina, United States

GSK Investigational Site

Columbus, Ohio, United States

GSK Investigational Site

Oklahoma City, Oklahoma, United States

GSK Investigational Site

Philadelphia, Pennsylvania, United States

GSK Investigational Site

Sellersville, Pennsylvania, United States

GSK Investigational Site

Dallas, Texas, United States

GSK Investigational Site

Houston, Texas, United States

GSK Investigational Site

San Antonio, Texas, United States

GSK Investigational Site

San Antonio, Texas, United States

GSK Investigational Site

Temple, Texas, United States

GSK Investigational Site

Midvale, Utah, United States

GSK Investigational Site

Renton, Washington, United States

GSK Investigational Site

Charleston, West Virginia, United States

GSK Investigational Site

Morgantown, West 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

Capital Fefderal, Buenos Aires, Argentina

GSK Investigational Site

Buenos Aires, , Argentina

GSK Investigational Site

Buenos Aires, , Argentina

GSK Investigational Site

Providencia / Santiago, Región Metro de Santiago, Chile

GSK Investigational Site

Santiago, Región Metro de Santiago, Chile

GSK Investigational Site

Santiago, Región Metro de Santiago, Chile

GSK Investigational Site

San José, , Costa Rica

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

Saint Petersburg, , Russia

GSK Investigational Site

Saint Petersburg, , Russia

GSK Investigational Site

Saint Petersburg, , Russia

GSK Investigational Site

Samara, , Russia

GSK Investigational Site

Yekaterinburg, , Russia

GSK Investigational Site

Busan, , South Korea

GSK Investigational Site

Daegu, , South Korea

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

Dnipro, , Ukraine

GSK Investigational Site

Donetsk, , Ukraine

GSK Investigational Site

Kharkiv, , Ukraine

GSK Investigational Site

Kyiv, , Ukraine

GSK Investigational Site

Kyiv, , Ukraine

GSK Investigational Site

Luhansk, , Ukraine

GSK Investigational Site

Lviv, , Ukraine

GSK Investigational Site

Odesa, , Ukraine

GSK Investigational Site

Poltava, , Ukraine

GSK Investigational Site

Vinnitsa, , Ukraine

GSK Investigational Site

Zaporizhzhya, , Ukraine

Countries

United States; Argentina; Chile; Costa Rica; Puerto Rico; Russia; South Korea; Ukraine

References

French JA, Hammer AE, Vuong A, Messenheimer JA. Analysis of three lamotrigine extended-release clinical trials: comparison of pragmatic ITT and LOCF methodologies. Epilepsy Res. 2012 Aug;101(1-2):141-7. doi: 10.1016/j.eplepsyres.2012.03.015. Epub 2012 Apr 10.

Reference Type: BACKGROUND

PMID: 22497754 (View on PubMed)

French JA, Temkin NR, Shneker BF, Hammer AE, Caldwell PT, Messenheimer JA. Lamotrigine XR conversion to monotherapy: first study using a historical control group. Neurotherapeutics. 2012 Jan;9(1):176-84. doi: 10.1007/s13311-011-0088-3.

Reference Type: BACKGROUND

PMID: 22139591 (View on PubMed)

Study Documents

Document Type: Study Protocol

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: 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: Informed Consent Form

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

LAM30055

Identifier Type: -

Identifier Source: org_study_id