Last updated: 11/04/2018 09:39:14

GW273225 Therapy Added To Current Seizure Treatments In Patients With Partial Seizures

GSK study ID
NEC107055
Clinicaltrials.gov ID
NCT00567424
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: An Open-label Evaluation of Drug Interactions, Safety, Tolerability and Efficacy of GW273225 Add-on Treatment of Partial Seizures, Whether or Not Secondarily Generalized
Trial description: Study to determine drug interactions between GW273225 and the anticonvulsants valproate, carbamazepine or phenytoin
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Drug: GW273225
    • Enrollment:
    0
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Epilepsy
    Product
    GW273225
    Collaborators
    None
    Study date(s)
    March 2008 to January 2009
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Confident diagnosis of epilepsy
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Confident diagnosis of epilepsy
    • Currently on VPA, CBZ or PHT
    • >or= 4 seizures/4 weeks prior to screen Exclusion criteria:
    • Prior lamotrigine use (excluded if treatment discontinued for clinically significant safety reasons (i.e., rash, hypersensitivity)).
    • Females of childbearing potential on hormonal contraceptives or hormone replacement therapy.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Clinical Trials Call Center
    Toledo, OH, United States, 43614
    Status
    Will Be Recruiting
    Contact us
    Location
    GSK Clinical Trials Call Center
    Tallahassee, FL, United States, 32308
    Status
    Will Be Recruiting
    Contact us
    Location
    GSK Clinical Trials Call Center
    St. Cloud, MN, United States, 56303
    Status
    Will Be Recruiting
    Contact us
    Location
    GSK Clinical Trials Call Center
    Little Rock, AR, United States, 72205
    Status
    Will Be Recruiting
    Contact us
    Location
    GSK Clinical Trials Call Center
    Medford, OR, United States, 97504
    Status
    Will Be Recruiting
    Contact us
    Location
    GSK Clinical Trials Call Center
    Rochester, MN, United States, 55905
    Status
    Will Be Recruiting
    Contact us
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    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Other
    Actual primary completion date
    Not applicable
    Actual study completion date
    Not applicable

    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

    Additional information
    Not applicable
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