AzTrials
AzTrials

EpilepsyPhase 2NCT00144690

E2007 Given as Adjunctive Therapy in Patients With Refractory Partial Seizures

A Phase 2 study testing E2007 (perampanel) in people with Epilepsy, run by Eisai Inc. at 5 sites in United States.

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 primary objective of this study is to determine the maximal tolerated dose (MTD) of E2007 given twice daily (bid) or once a day (qd) in patients with refractory partial-onset seizures (including secondarily generalized seizures). Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Epilepsy
What is being tested?
E2007 (perampanel)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
Not given
Where
5 sitesUnited States
Study dates
Mar 2005to Feb 2007
Phase
Phase 2
Are there results?
None posted in the registry

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 18 to 70 years
  • All sexes
  • Adult, Older adult

Who may be able to join

  • Provide written informed consent signed by patient or legal guardian prior to entering the study or undergoing any study procedures.
  • Are reliable and willing to make themselves available for the study period and are able to record seizures and report adverse events themselves or have a caregiver who can record and report the events.
  • Male and female patients will be eligible for enrollment. Females should be either of non-childbearing potential as a result of surgery, radiational therapy, menopause (one year post onset), or of childbearing potential and practicing a medically acceptable method of contraception (eg, abstinence, a barrier method plus spermicide, or intrauterine device [IUD]) for at least three months before Visit 1 (Screening) and for two months after the end of the study. They must also have a negative serum beta-human chorionic gonadotropin (beta-hCG) at Screening. Pregnant and/or lactating females are excluded. Those women using an oral contraceptive must also be using an additional approved method of contraception (eg, a barrier method plus spermicide, or IUD) starting with the Baseline Phase and continuing throughout the entire study period.
  • Are between the ages of 18 and 70 years of age, inclusive.
  • Are of 40 kg (88 lb) of weight or more.
  • Have the diagnosis of epilepsy with partial-onset 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, electroencephalogram (EEG) and computed tomography/magnetic resonance imaging (CT/MRI) of the brain performed within the last 10 years and consistent with localization-related epilepsy.
Show all 11Show fewer
  • Have uncontrolled partial seizures despite having been treated with at least three different anti-epileptic drugs (AEDs) (given concurrently or sequentially) for at least 2 years.
  • To be enrolled, patient must have averaged at least 4 partial seizures per month, with no 21-day seizure-free period during the 2 months preceding randomization. To be randomized, the patient must have had at least 3 seizures during the prospective Baseline Phase (28 days), with no 21-day seizure-free period. This should be documented in the form of medical history, medical records, or photocopied records of the patient diary/patient chart. Simple partial seizures without motor signs will not be counted towards this inclusion criterion.
  • Are currently being treated with one or a maximum of two licensed AEDs and are known to take their medication(s) as directed.
  • Are on a stable dose(s) of the same AED(s) for the 2 months prior to Visit 1.
  • If using a vagal nerve stimulator, it must have been implanted for at least 5 months prior to Visit 1. Stimulator parameters may not be changed for at least 1 month prior to Visit 1 or thereafter during the study. Magnet use will be allowed and documented throughout the study.

Who cannot join

  • Have participated in a study involving administration of an investigational compound within one month of Visit 1 (Screening), or within 5 half-lives of the previous investigational compound, whichever is longer.
  • Presence of non-motor simple partial seizures only.
  • Presence of primary generalized epilepsies or seizures, such as absences, myoclonic epilepsies, Lennox-Gastaut syndrome.
  • History of status epilepticus in the past year or seizure clusters where individual seizures cannot be counted.
  • Show evidence of clinically significant disease (cardiac, respiratory, gastrointestinal, renal disease, etc) that in the opinion of the Investigator(s) could affect the patient's safety or trial conduct.
  • Show 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 2 times the upper limit of normal (ULN).
Show all 19Show fewer
  • Show evidence of significant active hematological disease. White blood cell (WBC) count cannot be <= 2500/µL or an absolute neutrophil count <= 1000/µL.
  • Clinically significant electrocardiogram (ECG) abnormality, including prolonged QTc defined as >= 450 msec for males and >= 470 msec for females.
  • Presence of major active psychiatric disease. Patients taking a stable dose of selective serotonin reuptake inhibitor (SSRI) antidepressant will be allowed (except fluvoxamine).
  • Presence of a progressive central nervous system (CNS) disease, including degenerative CNS diseases and tumors.
  • Have a history of psychogenic seizures.
  • Have a history of drug abuse and/or positive finding on urinary drug screening, other than prescribed medication.
  • Have a history of alcohol abuse in the past 2 years, and/or positive finding on urinary drug screen.
  • Have had multiple drug allergies (dermatological, hematological or organ toxicity) or one or more severe drug reactions.
  • Allergy to lactose.
  • Concomitant use of felbamate or use of felbamate within 2 months prior to Visit 1.
  • Concomitant use of vigabatrin. Patients that took vigabatrin in the past must be off vigabatrin for at least 5 months prior to Visit 1 and must not have evidence of a clinically significant abnormality in a visual perimetry test.
  • Concomitant use or use within the previous 4 weeks prior to Visit 1 of neuroleptics, monoamine oxidase (MAO) inhibitors, barbiturates (except for seizure control indication), benzodiazepines (other than occasional intermittent use), and narcotic analgesics.
  • Frequent need of rescue benzodiazepines (one or more times a month).

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Clinical Trials

    Detroit, Michigan, 48202

  • Dept. of Neuro Surgery

    Little Rock, Arkansas, 72205

  • Vanderbilt University Medical Ctr.

    Nashville, Tennessee, 37212

  • USF Physicians Group

    Tampa, Florida, 33606

  • Medical College of Ohio Comprehensive Epilepsy Ctr.

    Toledo, Ohio, 43614

Other trials in United States

About this study

Official title: A Double-Blind, Placebo-Controlled, Dose-Escalation, Parallel-Group Study of E2007 Given as Adjunctive Therapy in Patients With Refractory Partial Seizures

The primary objective of this study is to determine the maximal tolerated dose (MTD) of E2007 given twice daily (bid) or once a day (qd) in patients with refractory partial-onset seizures (including secondarily generalized seizures). The secondary objectives are to evaluate the safety, efficacy, concentration-efficacy relationship, and pharmacokinetics of E2007 and the effects of E2007 on the Profile of Mood States (POMS) test.

Conditions
Epilepsy
Being tested
E2007 (perampanel), Placebo
Keywords
Epilepsy refractory partial seizures
Medical subject headings
Epilepsy

What participants receive

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

  • E2007 (perampanel)Drug

  • PlaceboDrug

What is being measured

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

  1. To determine the maximum tolerated dose (MTD) of E2007 given bid or qd in patients with refractory partial-onset seizures (including secondarily generalized seizures)

Secondary outcomes (1)

  1. To evaluate the safety, efficacy, and concentration-efficacy relationship

Timeline

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

  1. First posted5 Sep 2005 (estimated)
  2. Study startMar 2005
  3. Primary completionFeb 2007
  4. Study completionFeb 2007

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
IDs, dates and publications
ClinicalTrials.gov ID
NCT00144690
Sponsor's protocol ID
E2007-A001-206
Other IDs
2005-004199-18, 2005
Status last verified
Nov 2015
First submitted
1 Sep 2005
Last updated
3 Nov 2015
Results posted
No

Publications

  • Krauss GL, Bar M, Biton V, Klapper JA, Rektor I, Vaiciene-Magistris N, Squillacote D, Kumar D. Tolerability and safety of perampanel: two randomized dose-escalation studies. Acta Neurol Scand. 2012 Jan;125(1):8-15. doi: 10.1111/j.1600-0404.2011.01588.x. Epub 2011 Aug 29.

    PubMed 21883097

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing E2007 (perampanel) in people with Epilepsy, run by Eisai Inc. at 5 sites in United States.

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 11 inclusion and 19 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 3 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

To determine the maximum tolerated dose (MTD) of E2007 given bid or qd in patients with refractory partial-onset seizures (including secondarily generalized seizures). 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 NCT00144690, which also lists 3 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 3 Nov 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Clinical Trial NCT00144690 | AzTrials