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Safety and Pharmacokinetics Study of E2007 to Treat Partial and Generalised Seizures in People With Epilepsy | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Safety and Pharmacokinetics Study of E2007 to Treat Partial and Generalised Seizures in People With Epilepsy

A Randomised, Double-Blind, Placebo-Controlled Study of the Tolerability, Safety and Pharmacokinetics of E2007 in Epileptic Patients With Partial and Generalised Seizures

NCT03780907•Eisai Co., Ltd.

View on ClinicalTrials.gov

Summary

The objectives of this study were to assess the tolerability and safety of E2007 in patients with refractory partial or generalised seizures and to assess the pharmacokinetics of E2007 in epileptic patients receiving at least one concomitant anti-epileptic drug.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Males or females with simple or complex partial seizures with or without secondary generalization, or primary generalized tonic-clonic seizures according to the International League against Epilepsy classification. Patient records were to document the frequency of seizure.
•2. Age: 18 to 65 years.
•3. Race: any.
•4. Patients receiving up to two additional anti-epileptic medications at doses that were stable for at least the four weeks immediately preceding baseline.
•5. Patients willing and able to co-operate with the study procedures including completion of patient diaries.
•6. Patients living at home with a partner or carer able to monitor compliance.
•7. Patients giving informed consent to participate in the study.

Exclusion Criteria

•1. Pregnant or lactating women.
•2. Women of childbearing potential unless (1) surgically sterile or (2) practicing effective contraception (eg, abstinence, IUD or barrier method plus hormonal method) and having a negative serum beta-HCG result at screening and being willing to remain on the current form of contraception for the duration of the study. Postmenopausal women could be included but were to have been amenorrhoeic for at least 12 months to be considered as not being of child-bearing potential.
•3. Fertile men not willing to use reliable contraception or with partners not willing to use reliable contraception.
•4. Patients with status epilepticus within the past 24 months.
•5. Patients with unstable abnormalities of the hepatic, renal, cardiovascular, respiratory, abdominal, haematological, endocrine or metabolic systems which might complicate assessment of the tolerability of the study medication.
•6. Patients with significantly elevated liver enzymes (abnormal bilirubin level, or serum transaminase levels more than 1.5 times the upper limit of normal).
•7. Patients taking drugs other than anti-epileptic agents which induce the enzyme cytochrome P450 3A4 (since these might reduce the plasma concentration of E2007), including dexamethasone, rifabutin, rifampacin, St John's Wort.
•8. Patients with past or present drug or alcohol abuse.
•9. Patients with unstable psychiatric illness.
•10. Patients who had received an investigational drug within the three months before baseline.
+2 more criteria

Locations (1)

3ClinicalResearch AG

Hennigsdorf, Germany

Key Dates

Start Date

February 14, 2003

Primary Completion Date

August 6, 2003

Completion Date

August 6, 2003

Last Updated

December 19, 2018

Enrollment

ACTUAL participants

Conditions

Epilepsy

Interventions

E2007

DRUG

E2007

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 19, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Pharmacokinetics Study of E2007 to Treat Partial and Generalised Seizures in People With Epilepsy

Inclusion Criteria

Exclusion Criteria

Thalamus Seizure Detection With a Deep Brain Stimulator System

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Intracranial Investigation of Neural Circuity Underlying Human Mood

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