A Placebo-Controlled, Double-Blind Comparative Study of E2080 in Lennox-Gastaut Syndrome Patients (Study E2080-J081-304)
Condition: Lennox-Gastaut Syndrome
MeSH terms: Lennox Gastaut Syndrome; Syndrome
Intervention: Rufinamide (E2080); Placebo
Intervention description: Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period.
Target maintenance dose:
15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) >= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening); Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.
Intervention MeSH terms: Rufinamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 66.0
Sex: All
Minimum age: 4 Years
Maximum age: 30 Years
Healthy volunteers: No
Keywords: Epilepsy; Seizures

Summary:

      To confirm that the combination therapy of rufinamide has superior efficacy compared to
      placebo in patients with Lennox-Gastaut syndrome.
    

Eligibility criteria:

        Inclusion criteria

          1. Participants 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. Participants who had a slow spike-and-wave pattern in an electroencephalogram within 6
             months prior to the enrollment for the Observation Period.

          3. Participants who had at least a total of 90 seizures in the 28 days prior to the
             enrollment for the Observation Period.

          4. Participants who have been on 1 - 3 anti-epileptic drugs from 28 days prior to the
             enrollment for the Observation Period and have not changed the type of the
             anti-epileptic drugs.

          5. Participants who have not changed the type nor the dose or administration of the
             anti-epileptic drugs they are taking in the Observation Period.

        Exclusion criteria;

          1. Participants who had a history of generalized tonic-clonic status epilepticus within
             baseline.

          2. Participants who received drug therapy at least 4 times to be rescued from status
             epilepticus within baseline.

          3. Participants who had a history of hypoxia which needed emergency resuscitation within
             12 months prior to the Treatment Period.

          4. Participants 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. Participants who had a history of suicide attempt within the 1 year prior to the
             Treatment Period.

          6. Participants who had a history of or has an allergy to triazole compound.

          7. Participants who have clinically significant electrocardiogram abnormalities at
             baseline.

          8. Participants who are pregnant, who may be pregnant, who are lactating or who wish to
             be pregnant.