A Placebo-Controlled, Double-Blind Comparative Study of E2080 in Lennox-Gastaut Syndrome Patients (Study E2080-J081-304)
Information source: Eisai Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lennox-Gastaut Syndrome
Intervention: Rufinamide (E2080) (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Eisai Limited Official(s) and/or principal investigator(s): Hiroki Takano, Study Director, Affiliation: Neuroscience Clinical Development Section. JAC PCU. Eisai Co., Ltd.
Summary
To confirm that the combination therapy of rufinamide has superior efficacy compared to
placebo in patients with Lennox-Gastaut syndrome.
Clinical Details
Official title: A Placebo-Controlled, Double-Blind Comparative Study of E2080 in Lennox-Gastaut Syndrome Patients
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Percent Change in Tonic-Atonic Seizure Frequency From Baseline (Per 28 Days)
Secondary outcome: Number of Participants Achieving a 50% Reduction in Tonic-atonic Seizure FrequencyPercent Change in Total Seizure Frequency (Per 28 Days) Percentage Change in the Frequency of Seizures Other Than Tonic-atonic Seizures (Per 28 Days) Clinical Global Impression of Change (CGIC)
Eligibility
Minimum age: 4 Years.
Maximum age: 30 Years.
Gender(s): Both.
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.
Locations and Contacts
Nagoya-shi, Aichi, Japan
Matsuyama-shi, Ehime, Japan
Fukuoka-shi, Fukuoka, Japan
Hiroshima-shi, Hiroshima, Japan
Sapporo-shi, Hokkaido, Japan
Kobe-shi, Hyogo, Japan
Yokohama-shi, Kanagawa, Japan
Goshi-shi, Kumamoto, Japan
Iwamuma-shi, Miyagi, Japan
Omura-shi, Nagasaki, Japan
Nara-shi, Nara, Japan
Niigata-shi, Niigata, Japan
Yufu-shi, Oita, Japan
Okayama-shi, Okayama, Japan
Neyagawa-shi, Osaka, Japan
Osaka-shi, Osaka, Japan
Suita-shi, Osaka, Japan
Moriya-shi, Shiga, Japan
Shizuoka-shi, Shizuoka, Japan
Kodaira-shi, Tokyo, Japan
Kokubunji-shi, Tokyo, Japan
Shinjuku-ku, Tokyo, Japan
Toyoma-shi, Toyama, Japan
Additional Information
Starting date: June 2010
Last updated: January 29, 2014
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