Clinical trial NCT01146951: A Placebo-Controlled, Double-Blind Comparative Study of E2080 in Lennox-Gastaut Syndrome Patients (Study E2080-J081-304)
Official title: A Placebo-Controlled, Double-Blind Comparative Study of E2080 in Lennox-Gastaut Syndrome Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lennox-Gastaut Syndrome
Keywords: Epilepsy
Seizures
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2010-06-22
Enrollment: 66
Sex: ALL
Minimum age (years): 4
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Percent Change in Tonic-Atonic Seizure Frequency From Baseline (Per 28 Days)
timeFrame: Baseline (28 day observational period) and End of Treatment (28 day treatment period)
Secondary outcomes:
measure: Number of Participants Achieving a 50% Reduction in Tonic-atonic Seizure Frequency
timeFrame: 12 weeks
measure: Percent Change in Total Seizure Frequency (Per 28 Days)
timeFrame: Baseline (28 day observational period) and End of Treatment (28 day treatment period)
measure: Percentage Change in the Frequency of Seizures Other Than Tonic-atonic Seizures (Per 28 Days)
timeFrame: Baseline (28 day observational period) and End of Treatment (28 day treatment period)
measure: Clinical Global Impression of Change (CGIC)
timeFrame: Up to Week 12 of the treatment period
Other outcomes:
Locations:
city: Nagoya-shi
country: Japan
state: Aichi
city: Matsuyama-shi
country: Japan
state: Ehime
city: Fukuoka-shi
country: Japan
state: Fukuoka
city: Hiroshima-shi
country: Japan
state: Hiroshima
city: Sapporo-shi
country: Japan
state: Hokkaido
city: Kobe-shi
country: Japan
state: Hyogo
city: Yokohama-shi
country: Japan
state: Kanagawa
city: Goshi-shi
country: Japan
state: Kumamoto
city: Iwamuma-shi
country: Japan
state: Miyagi
city: Omura-shi
country: Japan
state: Nagasaki
city: Nara-shi
country: Japan
state: Nara
city: Niigata-shi
country: Japan
state: Niigata
city: Yufu-shi
country: Japan
state: Oita
city: Okayama-shi
country: Japan
state: Okayama
city: Neyagawa-shi
country: Japan
state: Osaka
city: Osaka-shi
country: Japan
state: Osaka
city: Suita-shi
country: Japan
state: Osaka
city: Moriya-shi
country: Japan
state: Shiga
city: Shizuoka-shi
country: Japan
state: Shizuoka
city: Kodaira-shi
country: Japan
state: Tokyo
city: Kokubunji-shi
country: Japan
state: Tokyo
city: Shinjuku-ku
country: Japan
state: Tokyo
city: Toyoma-shi
country: Japan
state: Toyama
Study officials:
affiliation: Neuroscience Clinical Development Section. JAC PCU. Eisai Co., Ltd.
name: Hiroki Takano
role: STUDY_DIRECTOR
References:
citation: Brigo F, Jones K, Eltze C, Matricardi S. Anti-seizure medications for Lennox-Gastaut syndrome. Cochrane Database Syst Rev. 2021 Apr 7;4(4):CD003277. doi: 10.1002/14651858.CD003277.pub4.
citation: Panebianco M, Prabhakar H, Marson AG. Rufinamide add-on therapy for drug-resistant epilepsy. Cochrane Database Syst Rev. 2020 Nov 8;11(11):CD011772. doi: 10.1002/14651858.CD011772.pub3.