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EpilepsyPhase 2NCT00416195

Exploring the Safety And Tolerability of Doses of E2007 up to a Maximum of 12 mg In Patients With Refractory Partial Seizures

A Phase 2 study testing E2007 in people with Epilepsy, run by Eisai Co., Ltd. at 2 sites in Latvia.

Completed

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

Official record
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Trial summary

This is a randomized, double-blind, placebo-controlled, parallel group study to determine the maximum tolerated dose of E2007. Epilepsy patients with refractory partial seizures will be divided into two groups of 24 patients each. 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
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
2 sitesLatvia
Study dates
Dec 2006to Mar 2008
Phase
Phase 2
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 18 to 70 years
  • All sexes
  • No healthy volunteers
  • 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 AEs 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 nonchildbearing potential as a result of surgery or menopause (1 year after onset), or of childbearing potential and practicing a medically acceptable method of contraception (e.g., abstinence, a barrier method plus spermicide, or intrauterine device [IUD]) for at least 1 month before Visit 1 (Screening) and for 1 month after the end of the study. They must also have a negative serum beta-human chorionic gonadotropin (B-hCG) at Screening. Those females using hormonal contraceptives must also be using an additional approved method of contraception (e.g., 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 pounds) of weight or more.
  • Have the diagnosis of epilepsy with partial seizures with or without secondarily generalized seizures according with the International League Against Epilepsy's Classification of Epileptic Seizures (1981). Diagnosis should have been established by clinical history, electroencephalogram and computed tomography/magnetic resonance imaging of the brain performed within the last 10 years and consistent with localization-related epilepsy.
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  • Have uncontrolled partial seizures despite having been treated with at least three different AEDs (given concurrently or sequentially) for at least 2 years.
  • Have averaged at least three partial seizures per month, with no 21-day seizure-free period during the 2 months preceding randomization. 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 to three (maximum) marketed and approved AEDs and are known to take their medications as directed. Use of a vagal nerve stimulator is not considered an AED by this criterion.
  • Are on a stable dose of the same AEDs for the 1 month prior to Visit 1.
  • If using a vagal nerve stimulator, it must have been implanted at least 5 months prior to Visit 1. Stimulator parameters may not be changed for at least 1 month prior to Visit 1 or 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 3 months of Visit 1 (Screening), or within 5 half-lives of the previous investigational compound, whichever is longer, or who have been previously treated with E2007.
  • Presence of nonmotor 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, could affect either the patient's safety or the conduct of the study.
  • Show evidence of significant, active, hepatic disease. Stable elevations of liver enzymes, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) due to concomitant medications will be allowed if they are less than 2 times the ULN.
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  • Show evidence of significant active hematological disease such as a white blood cell (WBC) count <= 2500/µL (2.50 1E+09/L), an absolute neutrophil count <= 1000/µL (1.00 1E+09/L), or a platelet count <100,000/mm^3.
  • Patients with clinically significant ECG abnormality, including prolonged QTc (defined as QTc >=450 msec using Fridericia's correction).
  • Presence of major active psychiatric disease. Patients taking a stable dose of selective serotonin reuptake inhibitor antidepressant (except fluvoxamine) will be allowed.
  • Presence of a progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors.
  • Have a history of psychogenic seizures in the past 2 years.
  • Pregnant or lactating females.
  • Have a history of drug abuse in the past 2 years 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 or use within the 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 (two or more times a month).

Trial locations and contacts

2 sites in 1 country.

Latvia2 sites

  • P. Stradina Clinical University Hospital

    Riga, LV-1002

  • Hospital Gailezers

    Riga, LV-1038

Other trials in Latvia

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Explore the Safety And Tolerability of Doses of E2007 up to a Maximum of 12 mg In Patients With Refractory Partial Seizures

This is a randomized, double-blind, placebo-controlled, parallel group study to determine the maximum tolerated dose of E2007. Epilepsy patients with refractory partial seizures will be divided into two groups of 24 patients each. One group will be patients who take concomitant inducing AEDs (anti-epileptic drugs) and the second group will be patients who do not take concomitant inducing AEDs. In each group, 18 patients will receive E2007 (dose escalating to a maximum of 12 mg per day) and six will receive placebo.

Conditions
Epilepsy
Being tested
E2007, Placebo
Medical subject headings
Epilepsy

What participants receive

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

  • E2007Drug

  • PlaceboDrug

Study groups in NCT00416195
Study groupRoleWhat they receive
E2007Experimental2 mg E2007 once daily for 2 weeks (Days 1 to 14), then 4 mg E2007 once daily for 2 weeks (Days 15 to 28), then 6 mg E2007 once daily for 2 weeks (Days 29 to 42), then 8 mg E2007 once daily for 2 weeks (Days 43 to 56), then 10 mg E2007 once daily for 2 weeks (Days 57 to 70), then 12 mg E2007 once daily for 6 weeks (Days 71 to 112).
Receives: Drug: E2007
PlaceboPlacebo comparatorMatching placebo once daily for 16 weeks (Days 1 to 112)
Receives: Drug: Placebo

What is being measured

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

  1. Percentage of Responders During the Maintenance Phase

    A patient is a responder if she/he experiences a 50% or greater reduction in seizure frequency from the baseline phase.

    Measured: Day 85 through Day 112

Secondary outcomes (1)

  1. Percentage Change in the 28-day Seizure Frequency From Baseline in the Maintenance LOCF

    Measured: Baseline, Day 85 through Day 112

Timeline

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

  1. First posted27 Dec 2006 (estimated)
  2. Study startDec 2006
  3. Primary completionFeb 2008
  4. Study completionMar 2008

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
Who is masked
Participant, Investigator
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00416195
Sponsor's protocol ID
E2007-G000-208
Other IDs
2006-003702-26
Status last verified
Aug 2013
First submitted
26 Dec 2006
Last updated
11 Jul 2014

Publications

  • 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 in people with Epilepsy, run by Eisai Co., Ltd. at 2 sites in Latvia.

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 11 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Latvia. 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 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?

Yes. Results are posted in the registry (first posted 22 Nov 2012). 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?

Percentage of Responders During the Maintenance Phase (time frame: Day 85 through Day 112). 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 NCT00416195, which also lists 2 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 11 Jul 2014.

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