Status:
COMPLETED
A Placebo-Controlled, Double-Blind Comparative Study of E2080 in Lennox-Gastaut Syndrome Patients (Study E2080-J081-304)
Lead Sponsor:
Eisai Limited
Conditions:
Lennox-Gastaut Syndrome
Eligibility:
All Genders
4-30 years
Phase:
PHASE3
Brief Summary
To confirm that the combination therapy of rufinamide has superior efficacy compared to placebo in patients with Lennox-Gastaut syndrome.
Eligibility Criteria
Inclusion
- Inclusion criteria
- 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).
- Participants who had a slow spike-and-wave pattern in an electroencephalogram within 6 months prior to the enrollment for the Observation Period.
- Participants who had at least a total of 90 seizures in the 28 days prior to the enrollment for the Observation Period.
- 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.
- 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;
- Participants who had a history of generalized tonic-clonic status epilepticus within baseline.
- Participants who received drug therapy at least 4 times to be rescued from status epilepticus within baseline.
- Participants who had a history of hypoxia which needed emergency resuscitation within 12 months prior to the Treatment Period.
- 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.
- Participants who had a history of suicide attempt within the 1 year prior to the Treatment Period.
- Participants who had a history of or has an allergy to triazole compound.
- Participants who have clinically significant electrocardiogram abnormalities at baseline.
- Participants who are pregnant, who may be pregnant, who are lactating or who wish to be pregnant.
Exclusion
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT01146951
Start Date
June 1 2010
End Date
August 1 2011
Last Update
January 24 2018
Active Locations (23)
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1
Nagoya, Aichi-ken, Japan
2
Matsuyama, Ehime, Japan
3
Fukuoka, Fukuoka, Japan
4
Hiroshima, Hiroshima, Japan