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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: EUCTR
Last refreshed on: 20 February 2017
Main ID:  EUCTR2016-004952-30-Outside-EU/EEA
Date of registration: 13/02/2017
Prospective Registration: Yes
Primary sponsor: Eisai Co, Ltd.
Public title: A Placebo-Controlled, Double-Blind Comparative Study of E2080 in Lennox-Gastaut Syndrome Patients
Scientific title: A Placebo-Controlled, Double-Blind Comparative Study of E2080 in Lennox-Gastaut Syndrome Patients
Date of first enrolment:
Target sample size: 58
Recruitment status: NA
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-004952-30
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2  
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries of recruitment
Japan
Contacts
Name: Customer Joy Department. EJ   
Address:  4-6-10 Koishikawa, Bunkyo-ku 112-8088 Tokyo Japan
Telephone: 8133817-3700
Email:
Affiliation:  Eisai Co., Ltd.
Name: Customer Joy Department. EJ   
Address:  4-6-10 Koishikawa, Bunkyo-ku 112-8088 Tokyo Japan
Telephone: 8133817-3700
Email:
Affiliation:  Eisai Co., Ltd.
Key inclusion & exclusion criteria
Inclusion criteria:
1. Participants who are diagnosed as LSG 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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 35
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 23
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Lennox-Gastaut Syndrome (LSG)
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Intervention(s)

Trade Name: Inovelon
Product Name: rufinamide
Product Code: E2080
Pharmaceutical Form: Tablet
INN or Proposed INN: RUFINAMIDE
CAS Number: 106308-44-5
Current Sponsor code: E2080
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)
Main Objective: To evaluate that the efficacy of E2080 in percent change in
tonic-atonic seizure frequency in participants with LGS relative to placebo.
Primary end point(s): Percent Change in Tonic-Atonic Seizure Frequency From Baseline (Per 28 Days)
Secondary Objective: To compare the efficacy of E2080 in terms of 50% responder
rate in tonic-atonic seizure frequency, percent change in the
total seizure frequency, percent change in the frequency of
seizures other than tonic-atonic seizures, and clinical global
impression of change (CGIC) in participants with LGS relative to
placebo, to compare the safety and tolerability of E2080 relative to
placebo and to evaluate the pharmacokinetics of E2080.
Timepoint(s) of evaluation of this end point: Baseline (28 day observational period) and End of Treatment (28 day treatment period)
Secondary Outcome(s)
Secondary end point(s): 1. Number of Participants Achieving a 50% Reduction in Tonic-atonic Seizure Frequency

2. Percent Change in Total Seizure Frequency (Per 28 Days)


3. Percentage Change in the Frequency of Seizures Other Than Tonic-atonic Seizures (Per 28 Days)

4. CGIC
Timepoint(s) of evaluation of this end point: 1. 12 weeks

2. Baseline (28 day observational period) and End of Treatment (28 day treatment period)

3. Baseline (28 day observational period) and End of Treatment (28 day treatment period)

4. Up to Week 12 of the treatment period

Secondary ID(s)
E2080-J081-304
NCT01146951
Source(s) of Monetary Support
Eisai Inc.
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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