A Placebo-Controlled, Double-Blind Comparative Study of E2080 in Lennox-Gastaut Syndrome Patients

Eisai Co., Ltd.0 个研究点目标入组 50 人开始时间: 2010年8月17日最近更新: 2023年10月17日

适应症

试验速览

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•Inclusion criteria;
•1. Patients who are diagnosed as Lennox-Gastaut syndrome with tonic/atonic seizures and atypical absence seizures (A history of atypical absence seizures will also be incorporated.)
•2. Patients who had a slow spike-and-wave pattern in an EEG within 6 months prior to the enrollment for the Observation Period.
•3. Patients who had at least a total of 90 seizures in the 28 days prior to the enrollment for the Observation Period.
•4. Patients who have been on 1 - 3 drugs of AED from 28 days prior to the enrollment for the Observation Period and have not changed the type of the AEDs.
•5. Patients who have not changed the type nor the dose or administration of the AEDs they are taking in the Observation Period.

•Exclusion criteria;
•1. Patients who had a history of generalized tonic-clonic status epilepticus within baseline.
•2. Patients who received drug therapy at least 4 times to be rescued from status epilepticus within baseline.
•3. Patients who had a history of hypoxia which needed emergency resuscitation within 12 months prior to the Treatment Period.
•4. Patients who were on a ketogenic diet or have received adrenocorticotropic hormone (ACTH) therapy or Vitamin B6 therapy within 6 months prior to the Treatment Period.
•5. Patients who had a history of suicide attempt within the 1 years prior to the Treatment Period.
•6. Patients who had a history of or has a allergy to triazole compound.
•7. Patients who have clinically significant ECG abnormalities in baseline.
•8. Patients who are pregnant, who may be pregnant, who are lactating or who wish to be pregnant.

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