Last updated: 11/04/2018 08:38:07
Clinical Evaluation of BW430C in Epilepsy
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
2009-26-03
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)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
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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