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Refractory Partial SeizuresPhase 3NCT00699972

Evaluating the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures

A Phase 3 study testing E2007 (perampanel) in people with Refractory Partial Seizures, run by Eisai Inc. at 97 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the safety, efficacy and tolerability of perampanel when given as an adjunctive therapy in subjects with refractory partial seizures. Read more about this study

Who is it for?
Ages 12 to 99 years
Conditions the study is for
Refractory Partial Seizures
What is being tested?
E2007 (perampanel)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
390 participants
Where
97 sitesin 6 countries
Study dates
30 Apr 2008to 19 Oct 2010
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 99 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Each subject must meet all of the following criteria to be enrolled in this study:
  • Provide written informed consent signed by the subject or legal guardian prior to entering the study or undergoing any study procedures (If the written informed consent is provided by the legal guardian because the subject is unable to do so, a written or verbal assent from the subject must also be obtained).
  • Be considered reliable and willing to be available for the study period and able to record seizures and report Adverse Events (AEs) them self or have a caregiver who can record seizures and report AEs for them.
  • Male or female and greater than or equal to 12 years of age (within the course of the study).
  • Females should be either of non-childbearing potential (defined as having undergone surgical sterilization, or postmenopausal [age 50 and amenorrheic for 12 months]) or of childbearing potential. Females of childbearing potential must have a negative serum Beta Human Chorionic Gonadotropin (ß-hCG) at Visit 1 and a negative urine pregnancy test prior to randomization at Visit 2. Female subjects of childbearing potential must agree to be abstinent or to use at least 1 medically acceptable method of contraception (eg, a double-barrier method [eg, condom + spermicide, condom + diaphragm with spermicide], IUD, or have a vasectomised partner) starting at Visit 1 and throughout the entire study period and for 2 months after the last dose of study drug. Those women using hormonal contraceptives must also be using an additional approved method of contraception (as described previously) starting at Visit 1 and continuing throughout the entire study period and for 2 months after the last dose of study drug. (It is not required for male subjects to use contraceptive measures based on preclinical toxicology data).
  • Have a diagnosis of epilepsy with partial seizures with or without secondarily generalized seizures according to the International League Against Epilepsy's Classification of Epileptic Seizures (1981). Diagnosis should have been established by clinical history and an electroencephalogram (EEG) that is consistent with localization-related epilepsy; normal interictal EEGs will be allowed provided that the subject meets the other diagnosis criterion (ie, clinical history).
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  • Have had a computed tomography (CT) or magnetic resonance imaging (MRI) within the last 10 years that ruled out a progressive cause of epilepsy.
  • Have uncontrolled partial seizures despite having been treated with at least 2 different anti-epileptic drugs (AEDs) within approximately the last 2 years.
  • During the 6-week Pre-randomization Phase subjects must have had ≥5 partial seizures per 6-week (with ≥2 partial seizures per each of 3-week period) and with no 25-day seizure-free period in the 6-week period, as documented via a valid seizure diary. Only simple partial seizures with motor signs, complex partial seizures, and complex partial seizures with secondary generalization are counted toward this inclusion.
  • Are currently being treated with stable doses of 1, 2 or a maximum of 3 approved AEDs. Only 1 inducer AED (defined as; carbamazepine, phenytoin, phenobarbital, or primidone only) out of the maximum of 3 AEDs is allowed.
  • Are on a stable dose of the same concomitant AED(s) for 1 month (or no less than 21 days) prior to Visit 1; in the case where a new AED regime has been initiated for a subject, the dose must be stable for 2 months (or no less than 49 days) prior to Visit 1.
  • If on a stable dose (other than intermittent rescue use) of benzodiazepines for epilepsy (or for anxiety or sleep disorders) the prescribed dose must be stable for 1 month (or no less than 21 days) prior to Visit 1. (Note: the use of intermittent rescue benzodiazepines is defined in the exclusion criterion #22 below.) When used in these cases (epilepsy, anxiety or sleep disorders), benzodiazepines will be counted as 1 AED; therefore, only 1 or a maximum of 2 additional approved AEDs will be allowed.
  • A vagal nerve stimulator (VNS) is allowed but it must have been implanted ≥5 months prior to Visit 1. Stimulator parameters can not be changed for 1 month (or no less than 21 days) prior to Visit 1 or thereafter during the study.

Who cannot join

  • Subjects who meet any of the following criteria will be excluded from the study:
  • Participated in a study involving administration of an investigational compound or device within 1 month (or no less than 21 days) prior to Visit 1, or within approximately 5 half-lives of the previous investigational compound, whichever is longer.
  • Pregnant and/or lactating.
  • Participated in previous perampanel studies.
  • Presence of nonmotor simple partial seizures only.
  • Presence of primary generalized epilepsies or seizures, such as absences and or myoclonic epilepsies.
Show all 24Show fewer
  • Presence or previous history of Lennox-Gastaut syndrome.
  • A history of status epilepticus within approximately 12 months prior to Visit 1.
  • Seizure clusters where individual seizures cannot be counted.
  • A history of psychogenic seizures.
  • Evidence of clinically significant disease (eg, cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the Investigator(s) could affect the subject's safety or the study conduct.
  • Scheduled and/or confirmed to have epilepsy surgery within 6 months after Visit 1; however those who have previously documented "failed" epilepsy surgery will be allowed.
  • 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 less than 3 times the upper limit of normal (ULN).
  • Evidence of significant active hematological disease; white blood cell (WBC) count <= 2500/µL (2.50 1E+09/L) or an absolute neutrophil count <= 1000/µL (1.00 1E+09/L).
  • A clinically significant electrocardiogram (ECG) abnormality, including prolonged QTc defined as >450 msec.
  • Suffering from psychotic disorder(s) and/or unstable recurrent affective disorder(s) evident by use of antipsychotics or have had a suicide attempt(s) within approximately the last 2 years.
  • Presence of a progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors.
  • History of drug or alcohol dependency or abuse within approximately the last 2 years.
  • 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.
  • If felbamate is used as a concomitant AED, subjects must be on felbamate for at least 2 years, with a stable dose for 2 months (or no less than 49 days) prior to Visit 1. They must not have a history of white blood cell (WBC) count below 2500/µL (2.50 1E+09/L), platelets below 100,000, liver function tests (LFTs) above 3 times the upper limit of normal (ULN), or other indication of hepatic or bone marrow dysfunction while receiving felbamate. If subjects received felbamate in the past, it must have been discontinued 2 months (or no less than 49 days) prior to Visit 1.
  • Concomitant use of vigabatrin. Subjects who took vigabatrin in the past must be off vigabatrin for approximately 5 months prior to Visit 1 and must have documentation showing no evidence of a vigabatrin associated clinically significant abnormality in a visual perimetry test.
  • Concomitant use of barbiturates (except for seizure control indication) within 1 month (or no less than 21 days) prior to Visit 1.
  • Use of intermittent rescue benzodiazepines (ie, 1-2 doses over a 24-hr period considered one-time rescue) 2 or more times in a 1-month period prior to Visit 1; or
  • Any condition(s) that will make the subject, in the opinion of the Investigator, unsuitable for the study.

Trial locations and contacts

97 sites in 6 countries.

97 sites in 6 countries

United States60 sites

  • Children's Hospital Medical Center Of Akron D/B/A Akron Children's Hospital

    Akron, Ohio, 44308

  • Albany Medical College

    Albany, New York

  • Blair Medical Assiciates, Inc.

    Altoona, Pennsylvania, 16602

  • McFarland Clinic, PC

    Ames, Iowa, 50010

  • Asheville Neurology Specialists, PA

    Asheville, North Carolina, 28806

  • PANDA

    Atlanta, Georgia, 30328

  • Children's Healthcare of Atlanta at Scottish Rite

    Atlanta, Georgia, 30342

  • Neurology/Johns Hopkins Hospital

    Baltimore, Maryland, 21287

  • Mid-Atlantic Epilepsy and Sleep Center

    Bethesda, Maryland, 20817

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • University of Alabama at Birmingham

    Birmingham, Alabama

  • Boston University Medical Center

    Boston, Massachusetts, 02118

  • Five Towns Neurology, PC

    Cedarhurst, New York, 11516

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • University Neurology, Inc.

    Cincinnati, Ohio, 45219

  • Michigan Neurology Associates, P.C.

    Clinton Township, Michigan, 48035

  • The Ohio State University Medical Center

    Columbus, Ohio, 43210

  • Dallas Pediatric Neurology Associates

    Dallas, Texas, 75230

  • Neurological Clinic of Texas, P.A.

    Dallas, Texas, 75230

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Mile High Research Center

    Denver, Colorado, 80218

  • Texas Tech University Health Sciences Center

    El Paso, Texas, 79905

  • Leonard J. Chabert Medical Center

    Houma, Louisiana, 70363

  • Texas Children's Hospital

    Houston, Texas, 77030

  • Josephson Wallack Munshower Neurology

    Indianapolis, Indiana, 46256

  • University of Florida Health Sciences, Jacksonville

    Jacksonville, Florida, 32209

  • University of Kentucky Research Foundation

    Lexington, Kentucky, 40508

  • Clinical Trials, Inc.

    Little Rock, Arkansas, 72205

  • Childrens Hospital Los Angeles

    Los Angeles, California, 90027

  • Kentucky Neuroscience Research

    Louisville, Kentucky, 40202

  • Pediatric Neurology and Epilepsy Center

    Loxahatchee Groves, Florida, 33470

  • Study site

    Loxahatchee Groves, Florida

  • UT Le Bonheur Pediatric Specialists

    Memphis, Tennessee, 38103

  • Children's Hospital of Wisconsin

    Milwaukee, Wisconsin, 53215

  • Regional Epilepsy Center

    Milwaukee, Wisconsin, 53215

  • Long Island Jewish Medical Center

    New Hyde Park, New York, 11040

  • Pediatric Neurology PA

    Orlando, Florida, 32819

  • North West Florida Clinical Research Group

    Pensacola, Florida, 32504

  • Child Neurology Center Of Nw Florida

    Pensacola, Florida, 32561

  • Children's Hospital Of Philadelphia

    Philadelphia, Pennsylvania

  • Thomas Jefferson University

    Philadelphia, Pennsylvania

  • St. Joseph's Hospital And Medical Center

    Phoenix, Arizona, 85013

  • Providence St. Vincent's Epilepsy Center

    Portland, Oregon

  • Virginia Commonwealth University Medical Center

    Richmond, Virginia, 23298

  • Univeristy of Rochester Strong Epilepsy Center

    Rochester, New York, 14642

  • Bright Minds Institute

    San Francisco, California, 94109

  • California Pacific Medical Center

    San Francisco, California, 94115

  • Lovelace Scientific Resources

    Sarasota, Florida, 34233

  • Ronald Aung-Din, MD, PC

    Sarasota, Florida, 34233

  • Harborview Medical Center

    Seattle, Washington, 98104

  • Louisiana State University Health Sciences Center

    Shreveport, Louisiana, 71103

  • Washington University

    St Louis, Missouri, 63110

  • Georgia Neurology and Sleep Medicine Associates

    Suwanee, Georgia, 30024

  • Tallahassee Neurological Clinic

    Tallahassee, Florida, 32308

  • Pediatric Epilepsy and Neurology Specialists

    Tampa, Florida, 33609

  • University Of Toledo Medical Center

    Toledo, Ohio

  • Neurological Associates of Tulsa, Inc.

    Tulsa, Oklahoma, 74137

  • Children's Research Institute

    Washington D.C., District of Columbia, 20010

  • Via Christi Comprehensive Epilepsy Center

    Wichita, Kansas, 67214

  • Study site

    Wichita, Kansas

Other trials in United States

Argentina12 sites

  • FLENI (Fundación para la Lucha Contra Las Enfermedades Neurológicas de La Infancia)

    Capital Federal- Provincia de Buenos Aires

  • Hospital Británico

    Capital Federal- Provincia de Buenos Aires

  • Hospital de Niños Ricardo Gutiérrez

    Capital Federal- Provincia de Buenos Aires

  • Hospital General de Agudos José María Ramos Mejia

    Capital Federal- Provincia de Buenos Aires

  • Hospital General de Agudos Teodoro Álvarez

    Capital Federal- Provincia de Buenos Aires

  • Hospital Italiano de Buenos Aires

    Capital Federal- Provincia de Buenos Aires

  • Policlínica Bancaria 9 de Julio

    Capital Federal- Provincia de Buenos Aires

  • Sanatorio Allende

    Córdoba, Córdoba Province

  • Hospital San Roque

    Córdoba, Córdoba- Provincia de Córdoba

  • Centro de Estudio y Tratamiento de la Epilepsia y Sueño- CETES S.A.

    Córdoba

  • Sanatorio Parque

    Rosario

  • Hospital Santa Clara de Asis

    Salta, Salta Province

Other trials in Argentina

Brazil11 sites

  • Faculdade de Ciências Médicas - UNICAMP

    Campinas

  • Hospital de Clinicas da UFPR

    Curitiba

  • Santa Casa de Porto Alegre

    Porto Alegre

  • HC Ribeirão Preto

    Ribeirão Preto

  • Hospital Pedro Ernesto - UERJ

    Rio de Janeiro

  • Hospital Universitário Professor Edgar Santos

    Salvador

  • Faculdade de Medicinade São José do Rio preto

    São José do Rio Preto

  • HC-FMUSP

    São Paulo

  • Hospital Brigadeiro

    São Paulo

  • Hospital Santa Marcelina

    São Paulo

  • UNIFESP

    São Paulo

Other trials in Brazil

Canada5 sites

  • Foothills Medical Center

    Calgary, Alberta

  • Neuro Rive-Sud

    Greenfield Park, Quebec, J4V 2J2

  • London Health Sciences Center

    London, Ontario

  • CHU Sainte-Justine

    Montreal, Quebec

  • Youthdale Treatment Centers

    Toronto, Ontario, M5B 1T9

Other trials in Canada

Mexico5 sites

  • Instituto Biomedico de Investigacion AC

    Aguascalientes, 20127

  • Sarug Reyes

    Aguascalientes, 20127

  • Medica Sur SIF-BIOTEC

    Mexico City, 14050

  • MIRC

    Monterrey, Nuevo Leon CP, 64000

  • Hospital Central "Dr. Ignacio Morones Prieto"

    San Luis Potosí City, 78240

Other trials in Mexico

Chile4 sites

  • Hospital Barros Luco Trudeau

    Santiago

  • Hospital Base Valdivia Servicio de Neurología

    Santiago

  • Hospital Dr. Sótero del Río

    Santiago

  • Neuropsicología Ltda.

    Santiago

Other trials in Chile

About this study

Official title: A Double-Blind, Placebo-Controlled, Dose-Escalation, Parallel-Group Study to Evaluate the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures

The purpose of this study is to evaluate the safety, efficacy and tolerability of perampanel when given as an adjunctive therapy in subjects with refractory partial seizures.

Being tested
E2007 (perampanel), Placebo
Keywords
E2007, perampanel, refractory partial seizures, adjunctive therapy, seizure frequency, partial onset seizures, reduction in seizure frequency, safety, concomitant AED(s)
Medical subject headings
Seizures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • E2007 (perampanel)Drug

    Also called Perampanel

    8 mg perampanel in a 1:1:1 ratio, 125 subjects/arm. All subjects will take a maximum of 6 tablets daily for the duration of the study and will be up-titrated weekly in 2-mg increments to their randomized dose.

  • E2007 (perampanel)Drug

    Also called Perampanel

    12 mg perampanel in a 1:1:1 ratio, 125 subjects/arm. All subjects will take a maximum of 6 tablets daily for the duration of the study and will be up-titrated weekly in 2-mg increments to their randomized dose.

  • PlaceboDrug

    Placebo in a 1:1:1 ratio, 125 subjects/arm. All subjects will take a maximum of 6 tablets daily for the duration of the study.

Study groups in NCT00699972
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: E2007 (perampanel)
2ExperimentalNot described
Receives: Drug: E2007 (perampanel)
3Placebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent Change in the 28-day Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases)

    Seizure frequency per 28 days was derived from the information recorded in the subject diaries.

    Measured: Baseline (Pre-randomization) through Week 19

Secondary outcomes (2)

  1. Percentage of Participants Who Were Responders

    A responder was a participant who had a 50 percent or greater reduction in seizure frequency per 28 days from the Pre-randomization phase.

    Measured: Baseline (Pre-randomization) through Week 19

  2. Percent Change in the 28-day Complex Partial Plus Secondarily Generalized Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases)

    Percent Change in the Seizure frequency per 28 days was derived from the information recorded in the subject diaries.

    Measured: Baseline (Pre-randomization) through Week 19

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2008 (estimated)
  2. Study start30 Apr 2008
  3. Primary completion19 Oct 2010
  4. Study completion19 Oct 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
390 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00699972
Sponsor's protocol ID
E2007-G000-304
Status last verified
Oct 2015
First submitted
17 Jun 2008
Last updated
10 Jan 2020
Data monitoring committee
No

Publications

  • French JA, Krauss GL, Biton V, Squillacote D, Yang H, Laurenza A, Kumar D, Rogawski MA. Adjunctive perampanel for refractory partial-onset seizures: randomized phase III study 304. Neurology. 2012 Aug 7;79(6):589-96. doi: 10.1212/WNL.0b013e3182635735. Epub 2012 Jul 25.

    PubMed 22843280

  • Bresnahan R, Hill RA, Wang J. Perampanel add-on for drug-resistant focal epilepsy. Cochrane Database Syst Rev. 2023 Apr 14;4(4):CD010961. doi: 10.1002/14651858.CD010961.pub2.

    PubMed 37059702

  • Maguire M. Response to "Perampanel and pregnancy: Could experience be a gloomy lantern that does not even illuminate its bearer?". Epilepsy Behav. 2022 Apr;129:108654. doi: 10.1016/j.yebeh.2022.108654. Epub 2022 Mar 16. No abstract available.

    PubMed 35305920

  • French JA, Gil-Nagel A, Malerba S, Kramer L, Kumar D, Bagiella E. Time to prerandomization monthly seizure count in perampanel trials: A novel epilepsy endpoint. Neurology. 2015 May 19;84(20):2014-20. doi: 10.1212/WNL.0000000000001585. Epub 2015 Apr 15.

    PubMed 25878175

  • Rosenfeld W, Conry J, Lagae L, Rozentals G, Yang H, Fain R, Williams B, Kumar D, Zhu J, Laurenza A. Efficacy and safety of perampanel in adolescent patients with drug-resistant partial seizures in three double-blind, placebo-controlled, phase III randomized clinical studies and a combined extension study. Eur J Paediatr Neurol. 2015 Jul;19(4):435-45. doi: 10.1016/j.ejpn.2015.02.008. Epub 2015 Mar 5.

    PubMed 25823975

  • Steinhoff BJ, Ben-Menachem E, Ryvlin P, Shorvon S, Kramer L, Satlin A, Squillacote D, Yang H, Zhu J, Laurenza A. Efficacy and safety of adjunctive perampanel for the treatment of refractory partial seizures: a pooled analysis of three phase III studies. Epilepsia. 2013 Aug;54(8):1481-9. doi: 10.1111/epi.12212. Epub 2013 May 10.

    PubMed 23663001

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing E2007 (perampanel) in people with Refractory Partial Seizures, run by Eisai Inc. at 97 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 97 sites in United States, Argentina, Brazil, Canada, Mexico and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change in the 28-day Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases) (time frame: Baseline (Pre-randomization) through Week 19). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00699972, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2020.

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