CompletedNCT00395694Updated Sep 26, 2018Results posted

Clinical Evaluation of BW430C in Epilepsy

A Phase 3 interventional study of lamictal in Epilepsy, sponsored by GlaxoSmithKline. Completed at 2 sites in Japan. Open to participants aged 2 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-09-26.

Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 102
Allocation: Non-randomized
Ages: 2 Years to 65 Years
Sex: All

Study summary

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

Conditions studied

Epilepsy

Browse trials for

Epilepsy 1,805

Keywords

epilepsy
Incidence of rash
safety evaluation for initial dose
patients with Valproic acid

In context

Epilepsy

1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.

This study's enrollment of 102 is above the median of 50 across 1,206 interventional studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 2 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Single group
Masking: None (open label)
Enrollment: 102 participants (actual)

Study arms

Experimental
lamictal
Drug: lamictal

Interventions

Druglamictal
anti-epileptic drug

What researchers measure

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
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.
Time frame: 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
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.
Time frame: 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.
Time frame: 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?".
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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?".
Time frame: 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.
Time frame: 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.
Time frame: Week 4 and Week 8

Results

Posted Sep 17, 2012

Participant flow

Escalation Phase + Maintenance Phase

Participant flow — Escalation Phase + Maintenance Phase
Milestone	Adults: LTG	Adolescents: LTG
Started	51	51
Completed	50	49
Not completed	1	2
Withdrew: Adverse event	1	2

Continuation Phase

Participant flow — Continuation Phase
Milestone	Adults: LTG	Adolescents: LTG
Started	49	48
Completed	34	35
Not completed	15	13
Withdrew: Adverse event	1	0
Withdrew: Lack of efficacy	12	11
Withdrew: Withdrawal due to wishes of family	1	0
Withdrew: Poor compliance	1	0
Withdrew: Withdrawal by subject	0	2

Outcome measures

PrimaryNumber 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.

Time frame:: 8 weeks
Reported as:: Number · participants

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
participants	Adults: LTG	Adolescents: LTG	Total: LTG
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	2	3	5

Statistical analysis

Total: LTG · Percentage of participants: 4.9 · 95% CI 1.6 to 11.1The estimated value represents the percentage of participants with rash events.

SecondaryNumber of Rash Events Experienced (Including SJS and Any Other Serious Drug Eruption) During the Initial 8 Weeks of Study Treatment

Time frame:: 8 weeks
Reported as:: Number · rash events

Number of Rash Events Experienced (Including SJS and Any Other Serious Drug Eruption) During the Initial 8 Weeks of Study Treatment
rash events	Adults: LTG	Adolescents: LTG	Total: LTG
Number of Rash Events Experienced (Including SJS and Any Other Serious Drug Eruption) During the Initial 8 Weeks of Study Treatment	3	4	7

SecondaryNumber 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.

Time frame:: 8 weeks
Reported as:: Number · participants

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
participants	Total: LTG
Severe	0
Moderate	2
Mild	3

SecondaryNumber 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?".

Time frame:: 8 weeks
Reported as:: Number · rash events

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
rash events	Total: LTG
Drug related	3
Not related to drug	4

SecondaryPercentage 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.

Time frame:: 8 weeks
Reported as:: Number · percentage of participants

Percentage of Participants With at Least a 50 Percent Reduction in Seizure Frequency for the Indicated Types of Seizures
percentage of participants	Adults: LTG	Adolescents: LTG	Total: LTG
All Partial Seizures, n=28, 25, 53	17.9	20.0	18.9
Tonic-clonic Seizures, n=5, 4, 9	60.0	0	33.3
Generalized Seizures with LGS, n=25, 25, 50	16.0	20.0	18.0

SecondaryPercent 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.

Time frame:: Pre-treatment (Day 0) and Week 8 of the Maintenance Phase (Study Week 14)
Reported as:: Median · percent change

Percent Change in Seizure Frequency of the Indicated Types of Seizures
percent change	Adults: LTG	Adolescents: LTG	Total: LTG
All Partial Seizures, n=28, 25, 53	6.3 (-44.8 to 28.7)	-11.1 (-46.6 to 34.6)	-9.8 (-42.3 to 28.6)
Tonic-clonic Seizures, n=5, 4, 9	83.3 (NA to NA)	27.4 (NA to NA)	36.5 (-47.9 to 100.0)
Generalized Seizures with LGS, n=25, 25, 50	18.6 (-16.2 to 32.2)	10.1 (-24.9 to 28.8)	12.4 (5.8 to 27.6)

SecondaryNumber 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)
Reported as:: Number · participants

Number of Participants With Any Rash Event (Including SJS and Any Other Serious Drug Eruption) up to the End of the Maintenance Phase
participants	Adults: LTG	Adolescents: LTG	Total: LTG
Number of Participants With Any Rash Event (Including SJS and Any Other Serious Drug Eruption) up to the End of the Maintenance Phase	2	3	5

SecondaryNumber 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)
Reported as:: Number · rash events

Number of Rash Events Experienced (Including SJS and Any Other Serious Drug Eruption) up to the End of the Maintenance Phase
rash events	Adults: LTG	Adolescents: LTG	Total: LTG
Number of Rash Events Experienced (Including SJS and Any Other Serious Drug Eruption) up to the End of the Maintenance Phase	3	4	7

SecondaryNumber 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)
Reported as:: Number · participants

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
participants	Total: LTG
Severe	0
Moderate	2
Mild	3

SecondaryNumber 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)
Reported as:: Number · rash events

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
rash events	Total: LTG
Drug related	3
Not related to drug	4

SecondaryNumber 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.

Time frame:: Up to Week 8 of the Maintenance Phase (Study Week 14)
Reported as:: Number · adjudicated rash events

Number of Rash Events (Including SJS and Any Other Serious Drug Eruption) Adjudicated by the Rash Adjudication Committee in Participants Taking VPA
adjudicated rash events	Adults: LTG	Adolescents: LTG	Total: LTG
Number of Rash Events (Including SJS and Any Other Serious Drug Eruption) Adjudicated by the Rash Adjudication Committee in Participants Taking VPA	1	2	3

SecondaryPercentage 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.

Time frame:: Week 4 and Week 8
Reported as:: Number · percentage of participants

Percentage of Participants With Monocyte Values Outside the Normal Range (Shifted High) at Weeks 4 and 8
percentage of participants	Total: LTG
Week 4	15.2
Week 8	16.2

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Adults: LTG	—	5/51 (9.8%)	48/51 (94.1%)
Adolescents: LTG	—	2/51 (3.9%)	50/51 (98%)
Total: LTG	—	7/102 (6.9%)	98/102 (96.1%)

Most frequent serious events

Most frequent serious events
Event	Adults: LTG	Adolescents: LTG	Total: LTG
SleepinessNervous system disorders	1/51	0/51	1/102
PyrexiaGeneral disorders	0/51	1/51	1/102
Drug eruptionSkin and subcutaneous tissue disorders	0/51	1/51	1/102
Status epilepticusNervous system disorders	1/51	0/51	1/102
PneumoniaInfections and infestations	1/51	0/51	1/102
VomitingGastrointestinal disorders	1/51	0/51	1/102
Aleviatin (phenytoin) poisoningInjury, poisoning and procedural complications	1/51	0/51	1/102
Frequent convulsionsNervous system disorders	0/51	1/51	1/102

Most frequent other events

Showing 10 of 15

Most frequent other events
Event	Adults: LTG	Adolescents: LTG	Total: LTG
Upper respiratory tract inflammationRespiratory, thoracic and mediastinal disorders	5/51	15/51	20/102
NasopharyngitisInfections and infestations	10/51	14/51	24/102
SomnolenceNervous system disorders	7/51	11/51	18/102
DiarrhoeaGastrointestinal disorders	3/51	11/51	14/102
DizzinessNervous system disorders	10/51	2/51	12/102
Arthropod stingInjury, poisoning and procedural complications	1/51	9/51	10/102
ContusionInjury, poisoning and procedural complications	8/51	4/51	12/102
PyrexiaGeneral disorders	7/51	6/51	13/102
VomitingGastrointestinal disorders	4/51	7/51	11/102
ExcoriationInjury, poisoning and procedural complications	6/51	2/51	8/102

Baseline characteristics

Age, Continuous
Age, Continuous(Years)	Adults: LTG	Adolescents: LTG	Total
Mean	29.0 ± 9.9	8.2 ± 4.1	18.6 ± 12.9

Sex: Female, Male
Sex: Female, Male(Participants)	Adults: LTG	Adolescents: LTG	Total
Female	23	25	48
Male	28	26	54

Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)	Adults: LTG	Adolescents: LTG	Total
Asian-Japanese	51	51	102

Study locations

2 sites

GSK Investigational Site
Kumamoto, 860-8556, Japan
GSK Investigational Site

References and documents

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.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 26, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00395694
Lead sponsor: GlaxoSmithKline
Responsible party: Sponsor
First posted: Nov 3, 2006
Start date: Aug 7, 2006
Primary completion: Mar 1, 2009
Completion: Mar 26, 2009
Results posted: Sep 17, 2012
Last update: Sep 26, 2018

Study contacts

GSK Clinical Trials

study director · GlaxoSmithKline

View the source record on ClinicalTrials.gov ↗

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