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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 Frequency

Percent 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

Page last updated: August 23, 2015

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