Clinical Evaluation of BW430C in Epilepsy

Overview[ - collapse ][ - ]

Purpose To evaluate safety information of BW430C when administered using the lower starting doses and slower dose escalations as recommended Global Data Sheet
ConditionEpilepsy
InterventionDrug: lamictal
PhasePhase 3
SponsorGlaxoSmithKline
Responsible PartyGlaxoSmithKline
ClinicalTrials.gov IdentifierNCT00395694
First ReceivedNovember 2, 2006
Last UpdatedApril 11, 2013
Last verifiedSeptember 2012

Tracking Information[ + expand ][ + ]

First Received DateNovember 2, 2006
Last Updated DateApril 11, 2013
Start DateAugust 2006
Estimated Primary Completion DateMarch 2009
Current Primary Outcome MeasuresNumber 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 [Time Frame: 8 weeks] [Designated as safety issue: No]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.
Current Secondary Outcome Measures
  • Number of Rash Events Experienced (Including SJS and Any Other Serious Drug Eruption) During the Initial 8 Weeks of Study Treatment [Time Frame: 8 weeks] [Designated as safety issue: No]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.
  • 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 [Time Frame: 8 weeks] [Designated as safety issue: No]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.
  • 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 [Time Frame: 8 weeks] [Designated as safety issue: No]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?".
  • Percentage of Participants With at Least a 50 Percent Reduction in Seizure Frequency for the Indicated Types of Seizures [Time Frame: 8 weeks] [Designated as safety issue: Yes]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.
  • Percent Change in Seizure Frequency of the Indicated Types of Seizures [Time Frame: Pre-treatment (Day 0) and Week 8 of the Maintenance Phase (Study Week 14)] [Designated as safety issue: No]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.
  • Number of Participants With Any Rash Event (Including SJS and Any Other Serious Drug Eruption) up to the End of the Maintenance Phase [Time Frame: Up to Week 8 of the Maintenance Phase (Study Week 14)] [Designated as safety issue: No]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.
  • Number of Rash Events Experienced (Including SJS and Any Other Serious Drug Eruption) up to the End of the Maintenance Phase [Time Frame: Up to Week 8 of the Maintenance Phase (Study Week 14)] [Designated as safety issue: No]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.
  • 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 [Time Frame: Up to Week 8 of the Maintenance Phase (Study Week 14)] [Designated as safety issue: No]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.
  • 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 [Time Frame: Up to Week 8 of the Maintenance Phase (Study Week 14)] [Designated as safety issue: No]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?".
  • Number of Rash Events (Including SJS and Any Other Serious Drug Eruption) Adjudicated by the Rash Adjudication Committee in Participants Taking VPA [Time Frame: Up to Week 8 of the Maintenance Phase (Study Week 14)] [Designated as safety issue: No]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.
  • Percentage of Participants With Monocyte Values Outside the Normal Range (Shifted High) at Weeks 4 and 8 [Time Frame: Week 4 and Week 8] [Designated as safety issue: No]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.

Descriptive Information[ + expand ][ + ]

Brief TitleClinical Evaluation of BW430C in Epilepsy
Official TitleClinical Evaluation of BW430C in Epilepsy
Brief Summary
To evaluate safety information of BW430C when administered using the lower starting doses
and slower dose escalations as recommended Global Data Sheet
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 3
Study DesignAllocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
ConditionEpilepsy
InterventionDrug: lamictal
anti-epileptic drug
Study Arm (s)Experimental: lamictal

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment102
Estimated Completion DateMarch 2009
Estimated Primary Completion DateMarch 2009
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
GenderBoth
Ages2 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesNot Provided

Administrative Information[ + expand ][ + ]

NCT Number NCT00395694
Other Study ID NumbersLAM107844
Has Data Monitoring CommitteeNot Provided
Information Provided ByGlaxoSmithKline
Study SponsorGlaxoSmithKline
CollaboratorsNot Provided
Investigators Study Director: GSK Clinical Trials GlaxoSmithKline
Verification DateSeptember 2012