Lennox-Gastaut Syndrome
Conditions
Interventions
investigational material(s)
Generic name etc : E2080
INN of investigational material :
Therapeutic category code : 113 Antiepileptics
Dosage and Administration for Investigational material : Oral
Sponsors
Eisai Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change in tonic-atonic seizure frequency from Baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Responder rate: % of patients who experience a response in tonic-atonic seizures of >= 50%; reduction in seizure frequency. | — |
Outcome results
None listed