Last updated: 11/04/2018 08:35:10

Study Evaluating LAMICTAL Extended-Release Therapy Added To Current Seizure Treatments In Patients With Partial Seizures

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GSK study ID
LAM100034
See study documents
Clinicaltrials.gov ID
NCT00113165
See results summary
EudraCT ID
2004-004342-41
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Multicenter, Double-Blind, Randomized, Parallel-group Evaluation of LAMICTAL Extended-release Adjunctive Therapy in Subjects with Partial Seizures
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

Median percent change from baseline in partial seizure frequency during the entire double-blind treatment phase.

Timeframe: Baseline (Week 4 before treatment) and Week 19

Secondary outcomes:

Median percent change from baseline in partial seizure frequency during the escalation phase, the maintenance phase, and during the last 8 weeks of the maintenance phase

Timeframe: Baseline (Week 4 before treatment) and escalation phase (Week 3 and Week 7), maintenance phase (Week 11, 15 and week 19) and Last 8 Weeks of Maintenance phase

Number of participants with ≥25%, ≥50%, ≥75% or 100% reduction in partial seizure frequency during the entire double-blind treatment phase, the escalation phase, the maintenance phase, and the last 8 weeks of the maintenance phase

Timeframe: Entire double-blind treatment phase (Week 19), escalation phase (Week 3 and Week 7), maintenance phase (Week 11, 15 and week 19),and Last 8 Weeks of Maintenance phase

Number of participants with 50% reduction in seizure frequency for all partial seizures at different timepoints

Timeframe: Weeks 2,4,8,12, 16, and Week 19

Number of participants with treatment-emergent adverse events (AEs) and serious adverse events (SAE)

Timeframe: Up to Week 19

Change from Baseline in body weight

Timeframe: Baseline (4 weeks before treatment) and Week 19

Number of participants with improved clinical status on the investigator assessment of participant’s clinical status questionnaire

Timeframe: Up to Week 19

Participant’s satisfaction with seizure control at end of study

Timeframe: Up to week 19

PK parameter: Total clearance (CL/F) of lamotrigine from plasma after oral adminstarion

Timeframe: Up to Week 19

PK parameter: Volume distribution (V/F) of lamotrigine after oral administration

Timeframe: Up to week 19

PK parameter: Absorption rate constant (Ka) for lamotrigine

Timeframe: up to week 19

Change from baseline in Profile of Mood States (POMS) score

Timeframe: Baseline (4 weeks before treatment) and Week 19

Change from baseline in Center for Epidemiological Studies- Depression Scale (CES-D) score

Timeframe: Baseline (4 weeks before treatment) and Week 19

Change from baseline in the Neurological Disorders Depression Inventory-Epilepsy (NDDI-E, 46-item research version) score

Timeframe: Baseline (4 weeks before treatment) and Week 19

Change from baseline in the Quality of Life in Epilepsy (QOLIE-31P) score

Timeframe: Baseline (4 weeks before treatment) and Week 19

Change from baseline in the Liverpool Adverse Experience Profile (LAEP) score

Timeframe: Baseline (4 weeks before treatment) and Week 19

Change from Baseline in the Seizure Severity Questionnaire (SSQ) score

Timeframe: Baseline (4 weeks before treatment) and Week 19

Change from baseline in the Epworth Sleepiness Scale (ESS) score

Timeframe: Baseline (4 weeks before treatment) and Week 19

Interventions:
  • Drug: LAMICTAL extended-release
    • Enrollment:
    236
    Primary completion date:
    2007-26-07
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    D. K. Naritoku, C. R. Warnock, J. A. Messenheimer, R. Borgohain, S. Evers, A. B. Guekht, V. A. Karlov, B. I. Lee and L. Ríos Pohl: Lamotrigine extended-release as adjunctive therapy for partial seizures. Neurology 2007;69;1610-1618
    Erratum: Lamotrigine extended-release as adjunctive therapy for partial seizures. Neurology 2009;72;201
    Medical condition
    Epilepsy
    Product
    lamotrigine
    Collaborators
    Not applicable
    Study date(s)
    October 2004 to July 2007
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    13+ years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Diagnosis of epilepsy with partial seizures for more than 24 weeks.
    Inclusion and exclusion criteria
    Inclusion 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Dallas, Texas, United States, 75230
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Radeberg, Sachsen, Germany, 01465
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Seoul, South Korea, 120-752
    Status
    Study Complete
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    Location
    GSK Investigational Site
    St.-Petersburg, Russia, 193019
    Status
    Study Complete
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    Location
    GSK Investigational Site
    San Antonio, Texas, United States, 78258
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Bamberg, Bayern, Germany, 96047
    Status
    Terminated/Withdrawn
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    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2007-26-07
    Actual study completion date
    2007-26-07

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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