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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT01146951
Date of registration: 14/06/2010
Prospective Registration: Yes
Primary sponsor: Eisai Limited
Public title: A Placebo-Controlled, Double-Blind Comparative Study of E2080 in Lennox-Gastaut Syndrome Patients (Study E2080-J081-304)
Scientific title: A Placebo-Controlled, Double-Blind Comparative Study of E2080 in Lennox-Gastaut Syndrome Patients
Date of first enrolment: June 2010
Target sample size: 66
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01146951
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 3
Countries of recruitment
Japan
Contacts
Name:     Hiroki Takano
Address: 
Telephone:
Email:
Affiliation:  Neuroscience Clinical Development Section. JAC PCU. Eisai Co., Ltd.
Key inclusion & exclusion 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.



Age minimum: 4 Years
Age maximum: 30 Years
Gender: All
Health Condition(s) or Problem(s) studied
Lennox-Gastaut Syndrome
Intervention(s)
Drug: Placebo
Drug: Rufinamide (E2080)
Primary Outcome(s)
Percent Change in Tonic-Atonic Seizure Frequency From Baseline (Per 28 Days) [Time Frame: Baseline (28 day observational period) and End of Treatment (28 day treatment period)]
Secondary Outcome(s)
Clinical Global Impression of Change (CGIC) [Time Frame: Up to Week 12 of the treatment period]
Number of Participants Achieving a 50% Reduction in Tonic-atonic Seizure Frequency [Time Frame: 12 weeks]
Percent Change in Total Seizure Frequency (Per 28 Days) [Time Frame: Baseline (28 day observational period) and End of Treatment (28 day treatment period)]
Percentage Change in the Frequency of Seizures Other Than Tonic-atonic Seizures (Per 28 Days) [Time Frame: Baseline (28 day observational period) and End of Treatment (28 day treatment period)]
Secondary ID(s)
E2080-J081-304
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 21/11/2013
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT01146951
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