Intervention: Lamotrigine
Trial phase: Phase 3
ATC code: N03AX09
SMILES: Nc1nnc(-c2cccc(Cl)c2Cl)c(N)n1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 20
Group description: In the EP, lamotrigine 0.3 mg/kg/day was administered orally once daily from W1 to W2, and 0.6 mg/kg/day from W3 to W4. From W5, the dose was escalated by 0.6 mg/kg/day once every 1 or 2 weeks, up to a maximum of 10.2 mg/kg/day or 400 mg/day, WWL, until a SF status was confirmed by HV-clinical signs. After a SF confirmation, the dose was increased by one level and HV-electroencephalography was assessed twice at the same dose level to confirm the SF status. In the MP, the same dose was continued for 12 weeks. An increase/decrease in dose (0.6 mg/kg/day at &gt;=1-week intervals) was allowed within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day, WWL. In the ExP, doses of 1.2 to 10.2 mg/kg/day or 400 mg/day (WWL) were administered based on seizure status/safety. If a dose &lt;1.2 mg/kg/day or &gt;10.2 mg/kg/day or 400 mg/day (WWL) was necessary, the participant was withdrawn from the study.
Eligibility criteria:
Inclusion Criteria:

Target disease: Subjects with newly diagnosed and untreated typical absence seizure which is classifiable by the International Classification of Seizures.

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.

Age (at the time of obtaining consent):

2 to 15 years of age in Japan
2 to 12 years of age in South Korea
Subjects must weigh at least 7 kg
Outpatients
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.
Gender: Male or female
QTc<450 millisecond (msec) or <480msec for subjects with Bundle Branch Block - values based on either single ECG values or triplicate ECG averaged QTc values obtained over a brief recording period.

Exclusion Criteria:

Subjects with partial seizure or generalized seizures other than typical absence.
Subjects with a history of rash associated with other treatment.
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.
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.
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.
Subjects with an acute or progressive neurological disorder or an organic disease.
Subjects with currently taking any psychoactive drugs to treat hyperactivity disorder or attention deficit disorder.
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).
Female subjects who are pregnant or lactating, who may be pregnant, or who plan for pregnancy during the study.
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.
Subjects taking inducers of lamotrigine glucuronidation (i.e., rifampicin, lopinavir/ritonavir), atazanavir/ritonavir, risperidone, oral contraceptives or hormone drug which includes estrogen.
Subjects having participated in other clinical study in the past 3 months before the start of investigational product.
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.
Subjects whom the investigator (or subinvestigator) considers ineligible for the study.