Clinical trial NCT00113165: Study Evaluating LAMICTAL Extended-Release Therapy Added To Current Seizure Treatments In Patients With Partial Seizures
Official title: A Multicenter, Double-Blind, Randomized, Parallel-group Evaluation of LAMICTAL Extended-release Adjunctive Therapy in Subjects With Partial Seizures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsy
Epilepsy, Partial
Keywords: partial seizures
Epilepsy
antiepileptic drugs
anticonvulsants
LAMICTAL
seizures
lamotrigine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-06-07
Enrollment: 244
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is being conducted to compare the efficacy and safety of LAMICTAL (lamotrigine) extended-release with placebo in the treatment of partial 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.


Eligibility criteria: Inclusion criteria:

* Diagnosis of epilepsy with partial seizures for more than 24 weeks.
* Must experience at least 8 partial seizures during an 8-week Baseline Phase.
* Must currently be receiving treatment with a stable regimen of one or two antiepileptic drugs for at least four weeks.
* Patient or parent/caregiver must be willing and able to maintain a written daily seizure diary.

Exclusion criteria:

* Previous treatment with lamotrigine.
* Exhibits any primary generalized seizures.
* Receiving treatment with felbamate or currently following the ketogenic diet.
* Pregnant, breastfeeding, or planning to become pregnant.

Primary outcomes:
measure: The efficacy of LAMICTAL extended-release therapy will be measured by the percentage change from Baseline in partial seizure frequency during the double-blind treatment phase.
timeFrame: 24 Weeks
Secondary outcomes:
measure: Reduction in partial seizure frequency during portions of double-blind phase (=25%,=50%,=75%,100%). Time to 50% reduction in partial seizure frequency. Adverse events. Weight change. Health outcomes questionnaires. Population Pharmacokinetics
timeFrame: 24 Weeks
Other outcomes:
Locations:
city: Anniston
country: United States
facility: GSK Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Northport
country: United States
facility: GSK Investigational Site
state: Alabama
city: Tuscaloosa
country: United States
facility: GSK Investigational Site
state: Alabama
city: Mesa
country: United States
facility: GSK Investigational Site
state: Arizona
city: Phoenix
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facility: GSK Investigational Site
state: Arizona
city: Scottsdale
country: United States
facility: GSK Investigational Site
state: Arizona
city: Sun City
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facility: GSK Investigational Site
state: Arizona
city: Tucson
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facility: GSK Investigational Site
state: Arizona
city: Little Rock
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facility: GSK Investigational Site
state: Arkansas
city: Los Angeles
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facility: GSK Investigational Site
state: California
city: Los Angeles
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facility: GSK Investigational Site
state: California
city: Newport Beach
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facility: GSK Investigational Site
state: California
city: Santa Monica
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facility: GSK Investigational Site
state: California
city: Sepuldeva
country: United States
facility: GSK Investigational Site
state: California
city: Washington
country: United States
facility: GSK Investigational Site
state: District of Columbia
city: Washington
country: United States
facility: GSK Investigational Site
state: District of Columbia
city: Hollywood
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facility: GSK Investigational Site
state: Florida
city: Maitland
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city: Ocala
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facility: GSK Investigational Site
state: Florida
city: Tallahassee
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state: Florida
city: Tampa
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city: Atlanta
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state: Georgia
city: Augusta
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facility: GSK Investigational Site
state: Georgia
city: Austell
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facility: GSK Investigational Site
state: Georgia
city: Savannah
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facility: GSK Investigational Site
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city: Chicago
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facility: GSK Investigational Site
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city: Flossmoor
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city: Wichita
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state: Kentucky
city: Louisville
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facility: GSK Investigational Site
state: Kentucky
city: Boston
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city: Detroit
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city: Grand Rapids
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facility: GSK Investigational Site
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city: Traverse City
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city: Minneapolis
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state: Minnesota
city: Minneapolis
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city: Chesterfield
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city: Kansas City
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facility: GSK Investigational Site
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city: St. Louis
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facility: GSK Investigational Site
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city: Las Vegas
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facility: GSK Investigational Site
state: Nevada
city: Edison
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state: New Jersey
city: West Orange
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facility: GSK Investigational Site
state: New Jersey
city: New York
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facility: GSK Investigational Site
state: New York
city: Plainview
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facility: GSK Investigational Site
state: New York
city: Asheville
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facility: GSK Investigational Site
state: North Carolina
city: Chapel Hill
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state: North Carolina
city: Greenville
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state: North Carolina
city: Raleigh
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state: North Carolina
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state: Ohio
city: Oklahoma City
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city: Oklahoma City
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state: Pennsylvania
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state: Pennsylvania
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state: Texas
city: Dallas
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state: Texas
city: Houston
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city: San Antonio
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city: Wichita Falls
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state: Utah
city: Richmond
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state: Virginia
city: Seattle
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state: Washington
city: Milwaukee
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state: Wisconsin
city: Capital Federal
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city: Curitiba
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facility: GSK Investigational Site
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city: Campinas
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city: Santiago
country: Chile
facility: GSK Investigational Site
state: Región Metro De Santiago
city: Santiago
country: Chile
facility: GSK Investigational Site
state: Región Metro De Santiago
city: Singen
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Ulm
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Alzenau
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facility: GSK Investigational Site
state: Bayern
city: Bamberg
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facility: GSK Investigational Site
state: Bayern
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state: Bayern
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state: Bayern
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state: Bayern
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state: Brandenburg
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state: Brandenburg
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state: Hessen
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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state: Sachsen-Anhalt
city: Halle
country: Germany
facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Magdeburg
country: Germany
facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Magdeburg
country: Germany
facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Naumburg
country: Germany
facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Chemnitz
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Floeha
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Radeberg
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Kiel
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Jena-Lobeda
country: Germany
facility: GSK Investigational Site
state: Thueringen
city: Jena
country: Germany
facility: GSK Investigational Site
state: Thueringen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Hyderabad, Andhra Pradesh
country: India
facility: GSK Investigational Site
city: Lucknow
country: India
facility: GSK Investigational Site
city: New Delhi
country: India
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: San German
country: Puerto Rico
facility: GSK Investigational Site
city: San Juan
country: Puerto Rico
facility: GSK Investigational Site
city: San Juan
country: Puerto Rico
facility: GSK Investigational Site
city: Ekaterinburg
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: St.-Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: St.-Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Kharkiv
country: Ukraine
facility: GSK Investigational Site
city: Kyiv
country: Ukraine
facility: GSK Investigational Site
city: Lviv
country: Ukraine
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Naritoku DK, Warnock CR, Messenheimer JA, Borgohain R, Evers S, Guekht AB, Karlov VA, Lee BI, Pohl LR. Lamotrigine extended-release as adjunctive therapy for partial seizures. Neurology. 2007 Oct 16;69(16):1610-8. doi: 10.1212/01.wnl.0000277698.33743.8b.
citation: van Dijkman SC, de Jager NCB, Rauwe WM, Danhof M, Della Pasqua O. Effect of Age-Related Factors on the Pharmacokinetics of Lamotrigine and Potential Implications for Maintenance Dose Optimisation in Future Clinical Trials. Clin Pharmacokinet. 2018 Aug;57(8):1039-1053. doi: 10.1007/s40262-017-0614-5.