Clinical trial NCT00395694: Clinical Evaluation of BW430C in Epilepsy
Official title: Clinical Evaluation of BW430C in Epilepsy<Phase III Study>
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsy
Keywords: epilepsy
Incidence of rash
safety evaluation for initial dose
patients with Valproic acid
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-11-03
Enrollment: 102
Sex: ALL
Minimum age (years): 2
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate safety information of BW430C when administered using the lower starting doses and slower dose escalations as recommended Global Data Sheet


Eligibility 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

Primary outcomes:
measure: 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:
measure: Number of Rash Events Experienced (Including SJS and Any Other Serious Drug Eruption) During the Initial 8 Weeks of Study Treatment
timeFrame: 8 weeks
measure: 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
measure: 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
measure: Percentage of Participants With at Least a 50 Percent Reduction in Seizure Frequency for the Indicated Types of Seizures
timeFrame: 8 weeks
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: Percentage of Participants With Monocyte Values Outside the Normal Range (Shifted High) at Weeks 4 and 8
timeFrame: Week 4 and Week 8
Other outcomes:
Locations:
city: Kumamoto
country: Japan
facility: GSK Investigational Site
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.