Clinical Trials Register

Summary
EudraCT Number:	2017-001180-20
Sponsor's Protocol Code Number:	E2007-G000-410
Clinical Trial Type:	Outside EU/EEA
Date on which this record was first entered in the EudraCT database:	2021-10-28
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED

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A. Protocol Information

A.2

EudraCT number

2017-001180-20

A.3

Full title of the trial

Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Perampanel as Monotherapy or First Adjunctive Therapy in Subjects With Partial Onset Seizures With or Without Secondarily Generalized Seizures or With Primary Generalized Tonic-Clonic Seizures

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Study to Evaluate the Efficacy and Safety of Perampanel as Monotherapy or First Add-on Therapy in Subjects With Partial Onset Seizures With or Without Secondarily Generalized Seizures or With Primary Generalized Tonic-Clonic Seizures

A.4.1

Sponsor's protocol code number

E2007-G000-410

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT03288129

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Eisai Inc.
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Eisai Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Eisai Inc.
B.5.2	Functional name of contact point	Eisai Medical Information
B.5.3	Address:
B.5.3.1	Street Address	100 Tice Boulevard Woodcliff Lake
B.5.3.2	Town/ city	New Jersey
B.5.3.3	Post code	07677
B.5.3.4	Country	United States
B.5.4	Telephone number	1888-274-2378
B.5.6	E-mail	esi_medinfo@eisai.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Fycompa
D.2.1.1.2	Name of the Marketing Authorisation holder	Eisai, Inc.
D.2.1.2	Country which granted the Marketing Authorisation	United States
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Perampanel
D.3.2	Product code	E2007
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Perampanel
D.3.9.1	CAS number	380917-97-5
D.3.9.2	Current sponsor code	E2007
D.3.9.3	Other descriptive name	PERAMPANEL
D.3.9.4	EV Substance Code	SUB32160
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Perampanel
D.3.9.1	CAS number	380917-97-5
D.3.9.2	Current sponsor code	E2007
D.3.9.3	Other descriptive name	PERAMPANEL
D.3.9.4	EV Substance Code	SUB32160
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	4
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Perampanel
D.3.9.1	CAS number	380917-97-5
D.3.9.2	Current sponsor code	E2007
D.3.9.3	Other descriptive name	PERAMPANEL
D.3.9.4	EV Substance Code	SUB32160
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	6
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Perampanel
D.3.9.1	CAS number	380917-97-5
D.3.9.2	Current sponsor code	E2007
D.3.9.3	Other descriptive name	PERAMPANEL
D.3.9.4	EV Substance Code	SUB32160
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	8
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Perampanel
D.3.9.1	CAS number	380917-97-5
D.3.9.2	Current sponsor code	E2007
D.3.9.3	Other descriptive name	PERAMPANEL
D.3.9.4	EV Substance Code	SUB32160
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Perampanel
D.3.9.1	CAS number	380917-97-5
D.3.9.2	Current sponsor code	E2007
D.3.9.3	Other descriptive name	PERAMPANEL
D.3.9.4	EV Substance Code	SUB32160
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	12
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Epilepsy:
Partial Onset Seizures with or without
1) Secondarily Generalized Seizures
2) Primary Generalized Tonic-Clonic Seizures

E.1.1.1

Medical condition in easily understood language

One part of brain affected called partial seizure. Partial seizures, encompass entire brain called generalized seizure. Disturbance in functioning of both sides of brain called Tonic-Clonic Seizures.

E.1.1.2

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	24.0
E.1.2	Level	PT
E.1.2	Classification code	10085326
E.1.2	Term	Parietal lobe epilepsy
E.1.2	System Organ Class	10029205 - Nervous system disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To assess the retention rate of perampanel when given as monotherapy or 1st adjunctive therapy in subjects with partial-onset seizures (POS) or primary generalized tonic-clonic seizures (PGTCS)

E.2.2

Secondary objectives of the trial

To evaluate the efficacy of perampanel when given as monotherapy or 1st adjunctive therapy in subjects with POS or PGTCS as measured by seizure freedom; to assess the proportion of subjects with POS or PGTCS that are able to convert from 1st adjunctive therapy to perampanel monotherapy; to assess the safety of perampanel as initial monotherapy or 1st adjunctive therapy in subjects with POS or PGTCS; to assess dosing and titration of perampanel when administered as initial monotherapy or 1st adjunctive therapy in subjects with POS or PGTCS

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Subjects will be male or female and no younger than 4 years of age and be able to swallow perampanel tablets.
2. Subjects must have a diagnosis of epilepsy with POS with or without secondarily generalized seizures (SGS) or with primary generalized tonic-clonic seizures (PGTCS). Either of the following must have occurred to support an epilepsy diagnosis:
a. At least two unprovoked (or reflex) seizures occurring greater than 24 hours apart
b. One unprovoked (or reflex) seizure with electroencephalography (EEG) evidence of seizures
3. Subjects who receive perampanel as a first adjunctive therapy must currently have been treated with stable doses of monotherapy with an anti-epileptic drug (AED) for 8 weeks prior to Visit 2 (Week 0), have not previously received adjunctive AED treatment, and must, in the investigator's judgement, be in need of initial adjunctive therapy after failure to control seizures with AED monotherapy, at the optimal dose and duration.
4. Subjects who receive perampanel as monotherapy, who were newly diagnosed (treatment naïve), following the defined diagnosis of epilepsy.
5. Subjects who are currently receiving monotherapy treatment may receive perampanel as monotherapy if, in the investigator's judgment, the participant may benefit from a change in monotherapy treatment. Subjects must not have previously received adjunctive AED treatment.
6. If antidepressants or antianxiety drugs are used, subjects must be on a stable dose regimen of these drugs during the 8 weeks before Visit 2 (Week 0).

E.4

Principal exclusion criteria

1.Subjects should not have previously received or currently be receiving perampanel.
2.Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta human chorionic gonadotropin [β-hCG] or hCG test with a minimum sensitivity of 25 International Units per liter [IU/L] or equivalent units of β-hCG or hCG); 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.
3.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:
•Total abstinence (if it is their preferred and usual lifestyle)
•An intrauterine device or intrauterine hormone-releasing system
•An oral contraceptive (with additional barrier method if using contraceptive containing levonorgestrel);
subject must be on a stable dose of the same oral contraceptive product for at least 28 days before
dosing and throughout the study and for 28 days after study drug discontinuation
•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
-For sites outside of the European Union, it is permissible that if a highly effective method of contraception is not appropriate or acceptable to the subject, then the subject must agree to use a medically acceptable method of contraception, i.e, double barrier methods of contraception such as condom plus diaphragm or cervical/vault cap with spermicide.
NOTE: All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (i.e, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing).
4.Presence of or previous history of Lennox-Gastaut syndrome
5.Presence of non-motor simple partial seizures only
6.A history of status epilepticus within 1 year before Screening Visit (Visit 1)
7.Subjects on antipsychotics or who have psychotic disorder(s) or unstable recurrent affective disorder(s) with a history of attempted suicide within 1 year before Screening Visit (Visit 1)
8.Presence of a progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors
9.Concomitant use of barbiturates (except for seizure control indication and premedication for electroencephalogram) and benzodiazepines (except for seizure control indication) within 8 weeks prior to Visit 2 (Week 0)
10.Use of intermittent rescue benzodiazepines (i.e, 1 to 2 doses over a 24-hour period is considered a one time rescue) 2 or more times in the 8-week period prior to Visit 2 (Week 0)
11.Severe renal insufficiency (defined by estimated glomerular filtration rate of < 30 milliliters per minute [mL/min]) or subjects who receive hemodialysis
12.Evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal disease, hepatic disease) that in the opinion of the investigator(s) could affect the subject’s safety or study conduct NOTE: Stable elevation of liver enzymes, alanine aminotransferase and aspartate aminotransferase due to concomitant medication(s) will be allowed if they are less than 3 times the upper limits of normal. 13.Hypersensitivity to perampanel or any excipients
14.Subjects with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
15.Subjects who are participating in other interventional clinical trial
16.Subject who are judged to have inadequate cognitive ability for participation in the study (intelligence quotient < 80 or investigator judgment)
17.Any suicidal ideation with intent with or without a plan, at the time of or within 6 months of screening, as indicated by answering "Yes" to questions 4 and 5 on the Suicidal Ideation section of the Columbia Suicide Severity Rating Scale (C-SSRS)
18.Any lifetime suicidal behavior based on the C-SSRS
19.Concomitant use of any form of cannabidiol (CBD)
20.Planned brain surgery during study participation

E.5 End points

E.5.1

Primary end point(s)

1. Percentage of subjects remaining on perampanel at 3 months after the initiation of treatment (retention rate) 2. Percentage of subjects remaining on perampanel at 6 months after the initiation of treatment (retention rate) 3. Percentage of subjects remaining on perampanel at 9 months after the initiation of treatment (retention rate) 4. Percentage of subjects remaining on perampanel at 12 months after the initiation of treatment (retention rate)

E.5.1.1

Timepoint(s) of evaluation of this end point

1. Month 3
2. Month 6
3. Month 9
4. Month 12

E.5.2

Secondary end point(s)

1. Percentage of subjects who achieve seizure-free status for partial-onset seizures (POS), secondarily generalized seizures (SGS), and primary generalized tonic-clonic seizures (PGTCS) during the Maintenance Period
2. Percentage of subjects who achieve 3-month seizure-free status for POS, SGS, and PGTCS
3. Percentage of subjects who achieve 6-month seizure-free status for POS, SGS, and PGTCS
4. Percentage of subjects who receive perampanel as a first adjunctive therapy who are able to convert to perampanel monotherapy
5. Number of subjects with any treatment-emergent adverse event (AE)
6. Number of subjects with any treatment-emergent serious adverse event (SAE)

E.5.2.1

Timepoint(s) of evaluation of this end point

1. Up to 39 weeks
2. Up to Month 3
3. Up to Month 6
4. Up to 39 weeks
5. Up to approximately 24 months
6. Up to approximately 24 months

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

Will this trial be conducted at a single site globally?

E.8.4

Will this trial be conducted at multiple sites globally?

Yes

E.8.6 Trial involving sites outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Yes

E.8.6.3

Specify the countries outside of the EEA in which trial sites are planned

United States

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

Last Visit Last Subject (LVLS) is when the final subject was examined or received an intervention for purposes of final collection of data for the primary and secondary outcome measures and adverse events.

E.8.9 Initial estimate of the duration of the trial

E.8.9.2

In all countries concerned by the trial months

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

F.1.1

Number of subjects for this age range:

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.2

For a multinational trial

F.4.2.2

In the whole clinical trial

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None

G. Investigator Networks to be involved in the Trial

H.4 Third Country in which the Trial was first authorised
H.4.1	Third Country in which the trial was first authorised:	United States

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IMP with orphan designation in the indication
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