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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epilepsy, Partial

Intervention: lamotrigine, 300 mg/day (Drug); lamotrigine, 250 mg/day (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: 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)

Secondary outcome:

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)

Time to Discontinuation in the Treatment Phase

Percentage of Participants Meeting Escape Criteria in the Treatment Phase

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

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

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

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)

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.

Eligibility

Minimum age: 13 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

GSK Investigational Site, Ciudad Autonoma de Buenos Aires, Argentina

GSK Investigational Site, Ciudad Autónoma de Buenos Aires 1425, Argentina

GSK Investigational Site, San Jose, Costa Rica

GSK Investigational Site, Busan 614-735, Korea, Republic of

GSK Investigational Site, Daegu 700-712, Korea, Republic of

GSK Investigational Site, Daejeon 301-721, Korea, Republic of

GSK Investigational Site, Seoul 138-736, Korea, Republic of

GSK Investigational Site, Seoul 110-744, Korea, Republic of

GSK Investigational Site, Seoul 120-752, Korea, Republic of

GSK Investigational Site, Seoul 135-170, Korea, Republic of

GSK Investigational Site, San Juan 00918, Puerto Rico

GSK Investigational Site, San Juan 00936, Puerto Rico

GSK Investigational Site, Ekaterinburg 620102, Russian Federation

GSK Investigational Site, Moscow 105066, Russian Federation

GSK Investigational Site, Moscow 117049, Russian Federation

GSK Investigational Site, Moscow 125412, Russian Federation

GSK Investigational Site, Samara 443095, Russian Federation

GSK Investigational Site, St.-Petersburg 193019, Russian Federation

GSK Investigational Site, St.-Petersburg 194291, Russian Federation

GSK Investigational Site, St.Petersburg 193167, Russian Federation

GSK Investigational Site, Dnepropetrovsk 49005, Ukraine

GSK Investigational Site, Donetsk 83037, Ukraine

GSK Investigational Site, Kharkiv 61068, Ukraine

GSK Investigational Site, Kyiv 02660, Ukraine

GSK Investigational Site, Kyiv, Ukraine

GSK Investigational Site, Lugansk 91045, Ukraine

GSK Investigational Site, Lviv 79021, Ukraine

GSK Investigational Site, Odesa 65006, Ukraine

GSK Investigational Site, Poltava, Ukraine

GSK Investigational Site, Vinnitsa 21005, Ukraine

GSK Investigational Site, Zaporizhzhya 69057, Ukraine

GSK Investigational Site, Alabaster, Alabama 35007, United States

GSK Investigational Site, Litchfield Park, Arizona 85340, United States

GSK Investigational Site, Mesa, Arizona 85201, United States

GSK Investigational Site, Phoenix, Arizona 85003, United States

GSK Investigational Site, Phoenix, Arizona 85013, United States

GSK Investigational Site, Tucson, Arizona 85724, United States

GSK Investigational Site, Tucson, Arizona 85741, United States

GSK Investigational Site, Fayetteville, Arkansas 72703, United States

GSK Investigational Site, Capital Federal, Buenos Aires 1181, Argentina

GSK Investigational Site, Capital Fefderal, Buenos Aires, Argentina

GSK Investigational Site, Los Angeles, California 90073, United States

GSK Investigational Site, Pasadena, California 91105, United States

GSK Investigational Site, Santa Ana, California 92705, United States

GSK Investigational Site, Santa Monica, California 90404, United States

GSK Investigational Site, Danbury, Connecticut 06810, United States

GSK Investigational Site, Fairfield, Connecticut 06824, United States

GSK Investigational Site, Newark, Delaware 19713, United States

GSK Investigational Site, Jacksonville, Florida 32224, United States

GSK Investigational Site, Loxahatchee, Florida 33470, United States

GSK Investigational Site, Sunrise, Florida 33351, United States

GSK Investigational Site, Tampa, Florida 33613, United States

GSK Investigational Site, Atlanta, Georgia 30338, United States

GSK Investigational Site, Atlanta, Georgia 30342, United States

GSK Investigational Site, Decatur, Georgia 30033, United States

GSK Investigational Site, Boise, Idaho 83702, United States

GSK Investigational Site, Chicago, Illinois 60611, United States

GSK Investigational Site, Chicago, Illinois 60637, United States

GSK Investigational Site, Flossmoor, Illinois 60422, United States

GSK Investigational Site, Urbana, Illinois 61801, United States

GSK Investigational Site, Des Moines, Iowa 50309, United States

GSK Investigational Site, Lexington, Kentucky 40536, United States

GSK Investigational Site, Lexington, Kentucky 40513, United States

GSK Investigational Site, Louisville, Kentucky 40202, United States

GSK Investigational Site, New Orleans, Louisiana 70115, United States

GSK Investigational Site, Bethesda, Maryland 20817, United States

GSK Investigational Site, Glen Burnie, Maryland 21061, United States

GSK Investigational Site, Pikesville, Maryland 21208, United States

GSK Investigational Site, Springfield, Massachusetts 01104, United States

GSK Investigational Site, Detroit, Michigan 48202, United States

GSK Investigational Site, Minneapolis, Minnesota 55455, United States

GSK Investigational Site, St. Cloud, Minnesota 56303, United States

GSK Investigational Site, Hattiesburg, Mississippi 39401, United States

GSK Investigational Site, Kansas City, Missouri 64111, United States

GSK Investigational Site, St. Louis, Missouri 63110, United States

GSK Investigational Site, St. Louis, Missouri 63104, United States

GSK Investigational Site, Henderson, Nevada 89014, United States

GSK Investigational Site, Las Vegas, Nevada 81902, United States

GSK Investigational Site, Las Vegas, Nevada 89106, United States

GSK Investigational Site, Edison, New Jersey 08818, United States

GSK Investigational Site, Vorhees, New Jersey 08043, United States

GSK Investigational Site, Lawrence, New York 11559, United States

GSK Investigational Site, Plainview, New York 11803, United States

GSK Investigational Site, Syracuse, New York 13210, United States

GSK Investigational Site, Asheville, North Carolina 28803, United States

GSK Investigational Site, Columbus, Ohio 43210-1296, United States

GSK Investigational Site, Oklahoma City, Oklahoma 73112, United States

GSK Investigational Site, Philadelphia, Pennsylvania 19107, United States

GSK Investigational Site, Sellersville, Pennsylvania 18960, United States

GSK Investigational Site, Providencia / Santiago, Región Metro De Santiago 7500710, Chile

GSK Investigational Site, Santiago, Región Metro De Santiago 7560356, Chile

GSK Investigational Site, Santiago, Región Metro De Santiago, Chile

GSK Investigational Site, Dallas, Texas 75230, United States

GSK Investigational Site, Houston, Texas 77025, United States

GSK Investigational Site, San Antonio, Texas 78229, United States

GSK Investigational Site, San Antonio, Texas 78258, United States

GSK Investigational Site, Temple, Texas 76502, United States

GSK Investigational Site, Midvale, Utah 84047, United States

GSK Investigational Site, Renton, Washington 98055, United States

GSK Investigational Site, Charleston, West Virginia 25301, United States

GSK Investigational Site, Morgantown, West Virginia 26506, United States

GSK Investigational Site, Madison, Wisconsin 53715, United States

GSK Investigational Site, Milwaukee, Wisconsin 53215, United States

Additional Information

Related publications:

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. Review.

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.

Starting date: May 2006
Last updated: October 30, 2014

Page last updated: August 23, 2015

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