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Epilepsy, PartialPhase 3NCT00355082

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

A Phase 3 study testing lamotrigine, 300 mg/day and lamotrigine, 250 mg/day in people with Epilepsy, Partial, run by GlaxoSmithKline at 103 sites in 8 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 determine the effectiveness of a lower monotherapy dose of lamotrigine than that currently approved. Read more about this study

Who is it for?
Ages 13 years and older
Conditions the study is for
Epilepsy, Partial
What is being tested?
lamotrigine, 300 mg/day and lamotrigine, 250 mg/day
Could I receive a placebo?
No, everyone receives an active treatment
How many people
226 participants
Where
103 sitesin 8 countries
Study dates
May 2006to Nov 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

  • 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:
  • 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
Show all 21Show fewer
  • Stability of prescribed dosages of background antiepileptic drug (AED)
  • 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:
  • 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).
  • 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.

Who cannot join

  • 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
Show all 16Show fewer
  • 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.

Trial locations and contacts

103 sites in 8 countries.

103 sites in 8 countries

United States67 sites

  • GSK Investigational Site

    Alabaster, Alabama, 35007

  • GSK Investigational Site

    Asheville, North Carolina, 28803

  • GSK Investigational Site

    Atlanta, Georgia, 30338

  • GSK Investigational Site

    Atlanta, Georgia, 30342

  • GSK Investigational Site

    Bethesda, Maryland, 20817

  • GSK Investigational Site

    Boise, Idaho, 83702

  • GSK Investigational Site

    Charleston, West Virginia, 25301

  • GSK Investigational Site

    Chicago, Illinois, 60611

  • GSK Investigational Site

    Chicago, Illinois, 60637

  • GSK Investigational Site

    Columbus, Ohio, 43210-1296

  • GSK Investigational Site

    Dallas, Texas, 75230

  • GSK Investigational Site

    Danbury, Connecticut, 06810

  • GSK Investigational Site

    Decatur, Georgia, 30033

  • GSK Investigational Site

    Des Moines, Iowa, 50309

  • GSK Investigational Site

    Detroit, Michigan, 48202

  • GSK Investigational Site

    Edison, New Jersey, 08818

  • GSK Investigational Site

    Fairfield, Connecticut, 06824

  • GSK Investigational Site

    Fayetteville, Arkansas, 72703

  • GSK Investigational Site

    Flossmoor, Illinois, 60422

  • GSK Investigational Site

    Glen Burnie, Maryland, 21061

  • GSK Investigational Site

    Hattiesburg, Mississippi, 39401

  • GSK Investigational Site

    Henderson, Nevada, 89014

  • GSK Investigational Site

    Houston, Texas, 77025

  • GSK Investigational Site

    Jacksonville, Florida, 32224

  • GSK Investigational Site

    Kansas City, Missouri, 64111

  • GSK Investigational Site

    Las Vegas, Nevada, 81902

  • GSK Investigational Site

    Las Vegas, Nevada, 89106

  • GSK Investigational Site

    Lawrence, New York, 11559

  • GSK Investigational Site

    Lexington, Kentucky, 40513

  • GSK Investigational Site

    Lexington, Kentucky, 40536

  • GSK Investigational Site

    Litchfield Park, Arizona, 85340

  • GSK Investigational Site

    Los Angeles, California, 90073

  • GSK Investigational Site

    Louisville, Kentucky, 40202

  • GSK Investigational Site

    Loxahatchee Groves, Florida, 33470

  • GSK Investigational Site

    Madison, Wisconsin, 53715

  • GSK Investigational Site

    Mesa, Arizona, 85201

  • GSK Investigational Site

    Midvale, Utah, 84047

  • GSK Investigational Site

    Milwaukee, Wisconsin, 53215

  • GSK Investigational Site

    Minneapolis, Minnesota, 55455

  • GSK Investigational Site

    Morgantown, West Virginia, 26506

  • GSK Investigational Site

    New Orleans, Louisiana, 70115

  • GSK Investigational Site

    Newark, Delaware, 19713

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73112

  • GSK Investigational Site

    Pasadena, California, 91105

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19107

  • GSK Investigational Site

    Phoenix, Arizona, 85003

  • GSK Investigational Site

    Phoenix, Arizona, 85013

  • GSK Investigational Site

    Pikesville, Maryland, 21208

  • GSK Investigational Site

    Plainview, New York, 11803

  • GSK Investigational Site

    Renton, Washington, 98055

  • GSK Investigational Site

    Saint Cloud, Minnesota, 56303

  • GSK Investigational Site

    San Antonio, Texas, 78229

  • GSK Investigational Site

    San Antonio, Texas, 78258

  • GSK Investigational Site

    Santa Ana, California, 92705

  • GSK Investigational Site

    Santa Monica, California, 90404

  • GSK Investigational Site

    Sellersville, Pennsylvania, 18960

  • GSK Investigational Site

    Springfield, Massachusetts, 01104

  • GSK Investigational Site

    St Louis, Missouri, 63104

  • GSK Investigational Site

    St Louis, Missouri, 63110

  • GSK Investigational Site

    Sunrise, Florida, 33351

  • GSK Investigational Site

    Syracuse, New York, 13210

  • GSK Investigational Site

    Tampa, Florida, 33613

  • GSK Investigational Site

    Temple, Texas, 76502

  • GSK Investigational Site

    Tucson, Arizona, 85724

  • GSK Investigational Site

    Tucson, Arizona, 85741

  • GSK Investigational Site

    Urbana, Illinois, 61801

  • GSK Investigational Site

    Vorhees, New Jersey, 08043

Other trials in United States

Ukraine11 sites

  • GSK Investigational Site

    Dnipro, 49005

  • GSK Investigational Site

    Donetsk, 83037

  • GSK Investigational Site

    Kharkiv, 61068

  • GSK Investigational Site

    Kyiv, 02660

  • GSK Investigational Site

    Kyiv

  • GSK Investigational Site

    Luhansk, 91045

  • GSK Investigational Site

    Lviv, 79021

  • GSK Investigational Site

    Odesa, 65006

  • GSK Investigational Site

    Poltava

  • GSK Investigational Site

    Vinnitsa, 21005

  • GSK Investigational Site

    Zaporizhzhya, 69057

Other trials in Ukraine

Russia8 sites

  • GSK Investigational Site

    Moscow, 105066

  • GSK Investigational Site

    Moscow, 117049

  • GSK Investigational Site

    Moscow, 125412

  • GSK Investigational Site

    Saint Petersburg, 193019

  • GSK Investigational Site

    Saint Petersburg, 193167

  • GSK Investigational Site

    Saint Petersburg, 194291

  • GSK Investigational Site

    Samara, 443095

  • GSK Investigational Site

    Yekaterinburg, 620102

Other trials in Russia

South Korea7 sites

  • GSK Investigational Site

    Busan, 614-735

  • GSK Investigational Site

    Daegu, 700-712

  • GSK Investigational Site

    Daejeon, 301-721

  • GSK Investigational Site

    Seoul, 110-744

  • GSK Investigational Site

    Seoul, 120-752

  • GSK Investigational Site

    Seoul, 135-170

  • GSK Investigational Site

    Seoul, 138-736

Other trials in South Korea

Argentina4 sites

  • GSK Investigational Site

    Buenos Aires, 1425

  • GSK Investigational Site

    Buenos Aires

  • GSK Investigational Site

    Capital Federal, Buenos Aires, 1181

  • GSK Investigational Site

    Capital Fefderal, Buenos Aires

Other trials in Argentina

Chile3 sites

  • GSK Investigational Site

    Providencia / Santiago, Región Metro de Santiago, 7500710

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 7560356

  • GSK Investigational Site

    Santiago, Región Metro de Santiago

Other trials in Chile

Puerto Rico2 sites

  • GSK Investigational Site

    San Juan, Puerto Rico, 00918

  • GSK Investigational Site

    San Juan, Puerto Rico, 00936

Other trials in Puerto Rico

Costa Rica1 site

  • GSK Investigational Site

    San José

Other trials in Costa Rica

About this study

Official title: A Multicenter, Double-Blind, Randomized Conversion to Monotherapy Comparison of Two Doses of Lamotrigine for the Treatment of Partial Seizures

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

Read the 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.

Being tested
lamotrigine, 300 mg/day, lamotrigine, 250 mg/day
Keywords
epilepsy, lamotrigine, Lamictal, monotherapy
Medical subject headings
Epilepsies, Partial, Epilepsy

What participants receive

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

  • lamotrigine, 300 mg/dayDrug

    Also called lamotrigine

    300 mg/day

  • lamotrigine, 250 mg/dayDrug

    250 mg/day

Study groups in NCT00355082
Study groupRoleWhat they receive
lamotrigine 300Experimental300 mg/day treatment
Receives: Drug: lamotrigine, 300 mg/day
lamotrigine 250Experimental250 mg/day treatment
Receives: Drug: lamotrigine, 250 mg/day

What is being measured

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

  1. The Percentage of Participants in the 300 mg/Day Dose Group Who Prematurely Discontinued the Study Between Study Visit 5 (Approximately Week 7) and Visit 9 (End of the Treatment Phase)

    The percentage of participants prematurely discontinuing the study was calculated as the number of participants who discontinued the study divided by the number who reached Visit 5 minus major protocol violators. The Control group is composed of data from other similar studies and is not part of this study.

    Measured: From Study Visit 5 through Visit 9 of the Treatment Phase (approximately Week 7 through Week 23)

Secondary outcomes (7)

  1. The Percentage of Participants in the 250 mg/Day Dose Group Who Prematurely Discontinued the Study Between Study Visit 5 (Approximately Week 7) and Visit 9 (End of the Treatment Phase)

    The percentage of participants prematurely discontinuing the study was calculated as the number of participants who discontinued the study divided by the number who had reached Visit 5 minus major protocol violators. The Control group was composed of data from other similar studies and is not part of this study.

    Measured: From Study Visit 5 through Visit 9 of the Treatment phase (approximately Week 7 through Week 23)

  2. Time to Discontinuation in the Treatment Phase

    Time (days) until the participant discontinued the study

    Measured: From Study Visit 5 through Visit 9 of the Treatment phase (approximately Week 7 through Week 23)

  3. Percentage of Participants Meeting Escape Criteria in the Treatment Phase

    The percentage of participants meeting Escape Criteria was calculated as the number of participants who met an Escape Criterion divided by the number who had reached Visit 5 minus major protocol violators. Escape Criteria are: (1) doubling of average monthly seizure frequency; (2) doubling of the highest consecutive 2-day seizure total; (3) occurrence of a new, more severe seizure type; or (4) worsening of generalized tonic-clonic seizures.

    Measured: Study Visit 5 through Visit 9 of the Treatment phase (approximately Week 7 through Week 23)

  4. Percent Change From Baseline in Weekly Seizure Frequency Between Study Visits 3 (Start of Dosing) and 9 (End of the Treatment Phase)

    Change from Baseline was measured as the number of seizures at Visits 3 through 9 minus the number of seizures at Baseline. The number of partial seizures during treatment divided by the number of weeks of treatment was compared to the weekly seizure frequency during Baseline. A positive number equals a reduction in seizure frequency.

    Measured: Baseline and Study Visit 3 through Visit 9 of the Treatment phase (Treatment Week 0 through Week 23)

  5. Number of Seizure-free Participants During the Last 12 Weeks of Treatment of the Treatment Phase

    The number of participants who had no seizures during the treatment period was calculated. The last 12 weeks of treatment were either Weeks 11-22 or 12-23 depending on which background AED was being withdrawn

    Measured: The last 12 weeks of treatment of the Treatment phase (Monotherapy phase - approximately Week 11 through Week 23)

  6. Percent Change From Baseline in the Average Seizure Frequency Measured at the End of Participation in the Continuation Phase

    Change from baseline was calculated as the average seizure frequency at the end of the Continuation Phase minus the average seizure frequency at Baseline. The number of seizures during the Continuation phase divided by the number of weeks was compared to the number of seizures at Baseline. A positive number indicates a reduction in seizure frequency.

    Measured: Baseline and start of Continuation phase through Week 24 or end of participation in the Continuation phase

  7. The Number of Participants With at Least the Specified Change in Seizure Frequency, Compared to Baseline, at the End of Participation in the Continuation Phase (Maximum of 24 Weeks)

    Change in seizure frequency was calculated as the average seizure frequency during the Continuation Phase minus the seizure frequency at Baseline.

    Measured: Baseline and entire Continuation phase (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 posted21 Jul 2006 (estimated)
  2. Study startMay 2006
  3. Primary completionNov 2008
  4. Study completionNov 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
226 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00355082
Sponsor's protocol ID
LAM30055
Status last verified
Nov 2016
First submitted
19 Jul 2006
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

  • 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.

    PubMed 22497754

  • 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.

    PubMed 22139591

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing lamotrigine, 300 mg/day and lamotrigine, 250 mg/day in people with Epilepsy, Partial, run by GlaxoSmithKline at 103 sites in 8 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 21 inclusion and 16 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 103 sites in United States, Ukraine, Russia, South Korea, Argentina and 3 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?

Yes. Results are posted in the registry (first posted 25 Nov 2009). 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?

The Percentage of Participants in the 300 mg/Day Dose Group Who Prematurely Discontinued the Study Between Study Visit 5 (Approximately Week 7) and Visit 9 (End of the Treatment Phase) (time frame: From Study Visit 5 through Visit 9 of the Treatment Phase (approximately Week 7 through Week 23)). 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 NCT00355082, 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 2 Jan 2017; AzTrials last refreshed its copy on 6 Nov 2026.

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