Clinical Evaluation of BW430C in Epilepsy

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

Official Title
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Clinical Evaluation of BW430C in Epilepsy<Phase III Study>

Conditions
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Epilepsy

Intervention / Treatment
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* Drug: lamictal


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lamictal<br> | Drug: lamictal<br>* anti-epileptic drug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Any rash event (including SJS or any other serious drug eruption) includes: all event terms containing rash; drug eruption; SJS; toxic epidermal necrolysis; rash generalized; and events grouped into the Skin and Subcutaneous Tissue Disorders system organ class per the Medical Dictionary for Regulatory Activities (MedDRA), including the above-mentioned events that the GSK medical advisors judged to be included as any rash event. SJS, also called as erythema multiforme, is a skin disorder resulting from an allergic reaction or infection. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Rash Events Experienced (Including SJS and Any Other Serious Drug Eruption) During the Initial 8 Weeks of Study Treatment | Any rash event (including SJS or any other serious drug eruption) includes: all event terms containing rash; drug eruption; SJS; toxic epidermal necrolysis; rash generalized; and events grouped into the Skin and Subcutaneous Tissue Disorders system organ class per the Medical Dictionary for Regulatory Activities (MedDRA), including the above-mentioned events that the GSK medical advisors judged to be included as any rash event. SJS, also called as erythema multiforme, is a skin disorder resulting from an allergic reaction or infection. | 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 | The rash events (including SJS and any other serious drug eruption) were classified into severe (rash prevents participant from leading a normal life), moderate (participant's discomfort due to rash interferes with daily life), and mild (no interference with participant's daily life due to rash), based on the intesity of the event. | 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 | The adverse event of rash was considered to be drug-related when the Investigator answered Yes to the following question: Is there a reasonable possibility that the adverse event may have been caused by the investigational product?. | 8 weeks | 
| Percentage of Participants With at Least a 50 Percent Reduction in Seizure Frequency for the Indicated Types of Seizures | Partial seizures are seizures that affect only a part of the brain at onset. Tonic-clonic seizures (grand mal seizures) affect the entire brain and are characterized by a generalized involuntary muscular contraction and cessation of respiration followed by tonic and clonic spasms of the muscles. Lennox-Gastaut syndrome (LGS) is a pediatric epilepsy syndrome characterized by multiple seizure types; mental retardation or regression; and abnormal findings on an electroencephalogram (EEG), with paroxysms of fast activity and generalized slow spike-and-wave discharges. | 8 weeks | 
| Percent Change in Seizure Frequency of the Indicated Types of Seizures | Percent change in seizure frequency was calculated as 100 * (pre-treatment seizures minus MP seizures)/pre-treatment seizures. Partial seizures are seizures that affect only a part of the brain at onset. Tonic-clonic seizures (grand mal seizures) affect the entire brain and are characterized by a generalized involuntary muscular contraction and cessation of respiration followed by tonic and clonic spasms of the muscles. Lennox-Gastaut syndrome (LGS) is a pediatric epilepsy syndrome characterized by multiple seizure types, mental retardation or regression, and abnormal findings on an ECG. | 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 | Any rash event (including SJS or any other serious drug eruption) includes: all event terms containing rash; drug eruption; SJS; toxic epidermal necrolysis; rash generalized; and events grouped into the Skin and Subcutaneous Tissue Disorders system organ class per the Medical Dictionary for Regulatory Activities (MedDRA), including the above-mentioned events that the GSK medical advisors judged to be included as any rash event. SJS, also called as erythema multiforme, is a skin disorder resulting from an allergic reaction or infection. | 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 | Any rash event (including SJS or any other serious drug eruption) includes: all event terms containing rash; drug eruption; SJS; toxic epidermal necrolysis; rash generalized; and events grouped into the Skin and Subcutaneous Tissue Disorders system organ class per the Medical Dictionary for Regulatory Activities (MedDRA), including the above-mentioned events that the GSK medical advisors judged to be included as any rash event. SJS, also called as erythema multiforme, is a skin disorder resulting from an allergic reaction or infection. | 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 | The rash events (including SJS and any other serious drug eruption) were classified into severe (rash prevents participant from leading a normal life), moderate (participant's discomfort due to rash interferes with daily life), and mild (no interference with participant's daily life due to rash), based on the intesity of the event. | 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 | The adverse event of rash was considered to be drug-related when the Investigator answered Yes to the following question: Is there a reasonable possibility that the adverse event may have been caused by the investigational product?. | 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 | The rash adjudication committee reviewed all rash events from a dermatologic standpoint based on the nature, onset site, affected area, time to onset, outcome, and the investigator's comments to adjudicate whether or not the reported event was a drug eruption. A drug eruption is an eruption or a solitary lesion caused by a drug taken internally, often a result of allergic sensitization. | 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 | Monocytes are a type of white blood cell (WBC; typically comprising 2%-8% of total WBCs) and are a part of the immune system. The normal range for adults is 0.2 to 0.95 * 10^3 cells per microliter (µL); the normal range for adolescents is 0 to 0.8 * 10^3 cells per µL. The monocyte count may increase during chronic inflammation, stress response, immune-mediated disease, viral fever, etc. The percentage of participants (par.) with monocyte values outside the normal range was calculated as 100 * (number of par. with monocyte values outside the normal range) divided by the total number of par. | Week 4 and Week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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epilepsy, Incidence of rash, safety evaluation for initial dose, patients with Valproic acid