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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: 26 February 2018
Main ID:  EUCTR2014-002321-35-FR
Date of registration: 21/02/2018
Prospective Registration: Yes
Primary sponsor: Eisai Limited
Public title: A global study completed at hospitals in US, Europe & Asia using an investigational drug (Perampanel) to research its safety & effectiveness in patients who are at least 2 years of age with Lennox-Gastaut Syndrome
Scientific title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial With an Open-Label Extension Phase of Perampanel as Adjunctive Treatment in Subjects at Least 2 years of Age With Inadequately Controlled Seizures Associated With Lennox-Gastaut Syndrome
Date of first enrolment:
Target sample size: 142
Recruitment status: NA
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-002321-35
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: 4
 
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries of recruitment
Australia Belgium Canada Czech Republic France Hungary Italy Japan
Korea, Republic of Latvia Poland United States
Contacts
Name: Medical Information   
Address:  European Knowledge Centre, Mosquito Way AL10 9SN Hatfield United Kingdom
Telephone: 440208600 1400
Email: EUMedInfo@eisai.net
Affiliation:  Eisai Europe Ltd.
Name: Medical Information   
Address:  European Knowledge Centre, Mosquito Way AL10 9SN Hatfield United Kingdom
Telephone: 440208600 1400
Email: EUMedInfo@eisai.net
Affiliation:  Eisai Europe Ltd.
Key inclusion & exclusion criteria
Inclusion criteria:
Subjects must meet all of the following criteria to be included in this study:
1. Subjects must have diagnosis of LGS as evidenced by:
a. More than one type of generalized seizures, including drop seizures (atonic, tonic, or myoclonic) for at least 6 months before Visit 1
b. An EEG reporting diagnostic criteria for LGS at some point in their history (abnormal background activity accompanied by slow, spike and wave pattern <2.5 Hz)
2. Subjects must be at least 2 years old at the time of consent.
3. Subjects must have been <11 years old at the onset of LGS.
4. Subjects must have experienced at least 2 drop seizures per week in the 4 -week Baseline Period preceding randomization; the Baseline Period within the Prerandomization Phase is 4 weeks.
5. Subjects must have been receiving 1 to 3 concomitant AEDs at a stable dose for at least 30 days before Visit 1 (vagal nerve stimulation [VNS] and ketogenic diet do not count as an AED).
6. In the investigator’s opinion, parents or caregivers must be able to keep accurate seizure diaries.
7. Body weight at least 8 kg
Are the trial subjects under 18? yes
Number of subjects for this age range: 135
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 6
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

Exclusion criteria:
1. Presence of progressive neurological disease
2. Presence of drop seizure clusters where individual seizures cannot be reliably counted
3. Prior treatment with perampanel with discontinuation due to safety issues (related to perampanel)
4. Prior treatment with perampanel must have been discontinued at least 30 days before Visit 1
5. Evidence of clinically significant disease (eg, cardiac, respiratory, gastrointestinal, renal disease, hepatic disease) that in the opinion of the investigator(s) could affect the subject’s safety or study conduct
6. Scheduled for epilepsy-related surgery or any other form of surgery during the projected course of the study
7. Ketogenic diet and VNS, unless stable and ongoing for at least 30 days before Visit 1
8. Treatment with an investigational drug or device in the 30 days before Visit 1
9. Status epilepticus within 12 weeks of Visit 1
10. If felbamate is used as a concomitant AED, subjects must be on felbamate for at least one year, with a stable dose for 60 days before Visit 1. They must not have an indication of hepatic or bone marrow dysfunction while receiving felbamate.
11. Concomitant use of vigabatrin: Subjects who took vigabatrin in the past must be discontinued for at least 5 months before Visit 1, and must have documentation showing no evidence of a vigabatrin-associated clinically significant abnormality in an automated visual perimetry test
12. Have had multiple drug allergies or a severe drug reaction to an AED(s), including dermatological (eg, Stevens-Johnson syndrome), hematological, or organ toxicity reactions
13. Evidence of significant active hepatic disease. Stable elevations of liver enzymes, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) due to concomitant medication(s) will be allowed if they are < 3 times the ULN
14. Adrenocorticotropic hormone within the 6 months before Visit 1
15. Had history of anoxic episodes requiring resuscitation within 6 months before Visit 1
16. Females who are breastfeeding or pregnant at Screening or Baseline. A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
17. Females of childbearing potential who:
Within 28 days before study entry, did not use a highly effective method of contraception, which includes any of the following:
o Total abstinence
o An intrauterine device or intrauterine hormone-releasing system (IUS)
o An oral contraceptive
o Have a vasectomized partner with confirmed azoospermia.
Do not agree to use a highly effective method of contraception (as described above) throughout the entire study period and for 28 days after study drug discontinuation.
18. Had intermittent use of benzodiazepine of more than 4 single administrations in the month before Visit 1
19. A prolonged QT/QTc interval as demonstrated by a repeated electrocardiogram (ECG)
20. Hypersensitivity to the study drug or any of the excipients
21. Any history of a medical condition or a concomitant medical condition that in the opinion of the investigator(s) would compromise the subject’s ability to safely complete the study
22. Known to be human immunodeficiency virus (HIV) positive
23. Active viral hepatitis (B or C) as demonstrated by positive serology at Screening
24. Psychotic disorder(s) or unstable recurrent affective disorder(s) evident by use of antipsychotics or prior suicide attempt(s) within approximately the last 2


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Seizures associated with Lennox-Gastaut Syndrome (LGS)
MedDRA version: 20.1 Level: PT Classification code 10048816 Term: Lennox-Gastaut syndrome System Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Intervention(s)

Trade Name: Fycompa
Product Name: perampanel
Product Code: E2007
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: perampanel
CAS Number: 380917-97-5
Current Sponsor code: E2007
Other descriptive name: PERAMPANEL
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Trade Name: Fycompa
Product Name: perampanel
Product Code: E2007
Pharmaceutical Form: Oral suspension
INN or Proposed INN: Perampanel
CAS Number: 380917-97-5
Current Sponsor code: E2007
Other descriptive name: PERAMPANEL
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 0.5-
Pharmaceutical form of the placebo: Oral suspension
Route of administration of the placebo: Oral use

Primary Outcome(s)
Main Objective: The primary objective of the study is to demonstrate that perampanel given as adjunctive antiepileptic treatment is superior compared to placebo in reducing the incidence of drop seizures during 18 weeks of treatment in subjects with inadequately controlled seizures associated with LGS.
Primary end point(s): The primary efficacy endpoint will be the median percent change in drop seizure frequency per 28 days.
Secondary Objective: 1. To demonstrate that peramapanel is superior to placebo in reducing the incidence of all seizures.
2. To demonstrate that perampanel is superior to placebo in the 50%, 75%, 100% responder rates for drop seizures.
3. To demonstrate that perampanel is superior to placebo in the 50%, 75%, 100% responder rates for total seizures.
4. To demonstrate that perampanel is superior to placebo in reducing the incidence of non-drop seizures.
5. To evaluate the 50%, 75%, and 100% responder rates in non-drop seizure frequency.
6. To evaluate physicians’ global evaluation of subjects’ overall changes in symptoms
7. To evaluate the safety of perampanel.
8. To evaluate the PK and PK/PD relationships of perampanel associated with LGS
Timepoint(s) of evaluation of this end point: Completion of Core Study
Secondary Outcome(s)
Secondary end point(s): 1. Median percent change in total seizure frequency per 28 days.
2. The 50% responder rate for drop seizures
3. The 50% responder rate for total seizures.
4. Median percent change in non-drop seizure frequency per 28 days.
5. Proportion of subjects with 75%, and 100% responder rates for drop, non -drop, and total seizures.
6. Proportion of subjects with 50% responder rate for non-drop seizures.
7. Physicians’ global evaluation of the subject’s overall changes in symptoms.
8. Incidence of AEs and SAEs, changes in clinical laboratory values, and vital signs.
9. Model-derived average perampanel concentrations.
Timepoint(s) of evaluation of this end point: Completion of Core Study
Secondary ID(s)
2014-002321-35-HU
E2007-G000-338
NCT02834793
Source(s) of Monetary Support
Eisai Inc.
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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