Last updated: 11/04/2018 08:38:07

Clinical Evaluation of BW430C in Epilepsy

GSK study ID
LAM107844
See study documents
Clinicaltrials.gov ID
NCT00395694
See results summary
EudraCT ID
Not applicable
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: Clinical Evaluation of BW430C in Epilepsy<Phase III Study>
Trial description: To evaluate safety information of BW430C when administered using the lower starting doses and slower dose escalations as recommended Global Data Sheet
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Number of participants with any rash event (including Stevens–Johnson syndrome [SJS] and any other serious drug eruption) during the initial 8 weeks of study treatment

Timeframe: 8 weeks

Secondary outcomes:

Number of rash events experienced (including SJS and any other serious drug eruption) during the initial 8 weeks of study treatment

Timeframe: 8 weeks

Number of participants with the indicated intensity of rash (including SJS and any other serious drug eruption) during the initial 8 weeks of study treatment

Timeframe: 8 weeks

Number of drug-related and not related rash events (including SJS and any other serious drug eruption) during the initial 8 weeks of study treatment

Timeframe: 8 weeks

Percentage of participants with at least a 50 percent reduction in seizure frequency for the indicated types of seizures

Timeframe: 8 weeks

Percent change in seizure frequency of the indicated types of seizures

Timeframe: Pre-treatment (Day 0) and Week 8 of the Maintenance Phase (Study Week 14)

Number of participants with any rash event (including SJS and any other serious drug eruption) up to the end of the maintenance phase

Timeframe: Up to Week 8 of the Maintenance Phase (Study Week 14)

Number of rash events experienced (including SJS and any other serious drug eruption) up to the end of the maintenance phase

Timeframe: Up to Week 8 of the Maintenance Phase (Study Week 14)

Number of participants with the indicated intensity of rash (including SJS and any other serious drug eruption) up to the end of the maintenance phase

Timeframe: Up to Week 8 of the Maintenance Phase (Study Week 14)

Number of drug-related and not related rash events (including SJS and any other serious drug eruption) up to the end of the maintenance phase

Timeframe: Up to Week 8 of the Maintenance Phase (Study Week 14)

Number of rash events (including SJS and any other serious drug eruption) adjudicated by the rash adjudication committee in participants taking VPA

Timeframe: Up to Week 8 of the Maintenance Phase (Study Week 14)

Percentage of participants with monocyte values outside the normal range (shifted high) at Weeks 4 and 8

Timeframe: Week 4 and Week 8

Interventions:
  • Drug: lamictal
    • Enrollment:
    102
    Primary completion date:
    2009-26-03
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Shunsuke Ohtahara, Tateki Fujiwara, Sunao Kaneko, Masafumi Iijima. Clinical Evaluation of Lamotrigine with the Current Recommended Dose in Overseas - Phase III study of lamotrigine in patients with epilepsy treated with valproate - . [J.New Rem. & Clin. Vol.57 No.9 2008]. 2008;57(J.New Rem. & Clin):1442-1453.
    Medical condition
    Epilepsy
    Product
    lamotrigine
    Collaborators
    GSK
    Study date(s)
    August 2006 to March 2009
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    2 - 65 years
    Accepts healthy volunteers
    No
    • Epilepsy with partial seizures
    • Tonic clonic seizures
    • Previous participation in a study of Lamictal
    • Known hypersensitivity to any drugs
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Epilepsy with partial seizures
    • Tonic clonic seizures
    • Generalized seizures of Lennox-Gastaut
    • Subjects whose seizures are easily recognizable at least one seizure per month and counts for 8 consecutive weeks prior to the start of the study drug.
    • Concurrent AEDs: Subjects taking concurrent VPA.
    Exclusion criteria:
    • Previous participation in a study of Lamictal
    • Known hypersensitivity to any drugs
    • Pregnant women
    • nursing mothers
    • women who may be pregnant
    • women contemplating pregnancy during the study period

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Unknown, Japan
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Kumamoto, Japan, 860-8556
    Status
    Study Complete
    Contact us

    Study documents

    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
    2009-26-03
    Actual study completion date
    2009-26-03

    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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