Typical absence seizure MedDRA version: 20.0 Level: LLT Classification code 10000331 Term: Absence seizure System Organ Class: 100000014665
Conditions
Interventions
Trade Name: LAMICTIN,Lamictal,Lamictal XR
Product Name: Lamotrigine
Product Code: GI267119
Pharmaceutical Form: Tablet
INN or Proposed INN: LAMOTRIGINE
Other descriptive name: LAMOTRIGINE
Concentratio
Sponsors
GlaxoSmithKline KK
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Target disease: Subjects with newly diagnosed and untreated typical absence seizure which is classifiable by the International Classification of Seizures. 2. Diagnosis of typical absence seizures is established by at least one of two 4-minute hyperventilation tests as supported by clinical signs and EEG findings. The following criteria will be used to define a typical absence seizure on the EEG: a discharge of generalized spike-and-wave or multiple spike-and-wave activity lasting =3 seconds during the awake state. The frequency of the spike-and-wave should be between 2.5-4.5 Hz. 3. Age (at the time of obtaining consent): • 2 to 15 years of age in Japan • 2 to 12 years of age in South Korea 4. Subjects must weigh at least 7 kg 5. Outpatients 6. Parent/guardian must have given written informed consent. Subjects who are intellectually able to understand the concepts and procedures of the protocol must give assent by also signing the consent. 7. Gender: Male or female 8. QTc=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subjects with partial seizure or generalized seizures other than typical absence. 2. Subjects with a history of rash associated with other treatment. 3. Subjects with any clinically significant chronic cardiac, renal, or hepatic medical condition. Any patient with these conditions will be excluded from the study even if these conditions are being controlled with chronic therapy. 4. Subjects with an acute or chronic illness likely to impair drug absorption, distribution, metabolism or excretion or with any unstable physical symptoms likely to require hospitalization during participation in the study. 5. Subjects with a psychiatric disorder requiring medication, or who had psychiatric conditions in the past that was both judged to be severe and required hospitalization. 6. Subjects with an acute or progressive neurological disorder or an organic disease. 7. Subjects with currently taking any psychoactive drugs to treat hyperactivity disorder or attention deficit disorder. 8. Subjects with an unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert’s syndrome or asymptomatic gallstones). 9. Female subjects who are pregnant or lactating, who may be pregnant, or who plan for pregnancy during the study. 10. Children in foster care: A child who has been placed under the control or protection of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation. This can include a child cared for by foster parents or living in a care home or institution, provided that the arrangement falls within the definition above. The definition of a child in care does not include a child who is adopted or who has an appointed legal guardian. 11. Subjects taking inducers of lamotrigine glucuronidation (i.e., rifampicin, lopinavir/ritonavir), atazanavir/ritonavir, risperidone, oral contraceptives or hormone drug which includes estrogen. 12. Subjects having participated in other clinical study in the past 3 months before the start of investigational product. 13. Subjects who have active suicidal plan/intent or have had active suicidal thoughts in the past 3 months before the start of investigational product or who have history of suicide attempt in the last 1 year before the start of investigational product or more than 1 lifetime suicide attempt. 14. Subjects whom the investigator (or subinvestigator) considers ineligible for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Not Applicable;Primary end point(s): Proportion of subjects seizure-free confirmed by HV-EEG at the end of the maintenance phase [Maintenance-Visit 3 (M-V3)]: [Number of subjects seizure-free confirmed by HV-EEG at the end of the maintenance phase (M-V3) / Number of subjects who have received the investigational product;Timepoint(s) of evaluation of this end point: The end point was assessed at the end of the maintenance phase of the study- Week 16;Main Objective: To evaluate the efficacy and safety of lamotrigine monotherapy in newly diagnosed typical absence seizures in pediatric patients in Japan and South Korea [initial dose 0.3 mg/kg/day, maintenance dose 1.2-10.2 mg/kg/day or 400 mg/day (whichever was less)] administered orally once daily (when the number of tablets taken at a time increases, the dose can be administered in two divided doses per day). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Proportion of subjects seizure-free confirmed by HV-EEG at the two consecutive visits in the escalation phase • Proportion of subjects seizure-free confirmed by HV-clinical signs at each visit during the escalation phase • Proportion of subjects seizure-free confirmed by HV-clinical signs during the maintenance phase • Number of days with seizure episodes on seizure diary per week (fixed escalation phase, escalation phase, maintenance phase, fixed escalation phase + escalation phase + maintenance phase);Timepoint(s) of evaluation of this end point: Endnotes were assessed through out the course of the study- Week 16 | — |
Countries
Japan, Korea, Republic of
Contacts
Public ContactKihito Takahashi & Yotaro Numachi
GlaxoSmithKline K.K.
Outcome results
None listed