A randomized, controlled, double-blind, two-arm clinical trial to assess safety and efficacy of transcutaneous vagus nerve stimulation (t-VNS®) in patients with drug-resistant epilepsy - cMPsE02

cerbomed GmbH0 sites77 target enrollmentApril 2, 2012

Overview

No summary available.

Registry

who.int

Start Date

April 2, 2012

End Date

August 26, 2014

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

cerbomed GmbH

•To be eligible for inclusion into this study, the patient must fulfill all of the following criteria prior to enrollment:
•Males or females \= 18 and \= 65 years of age.
•Must be able to consent to participation by signing the informed consent form.
•Has any of a broad range of epilepsy syndromes (e.g. with simple or complex partial or primary or secondary generalized seizures).
•Has \= 3 seizures per month and not more than 21 days between seizures, both prior to screening (assessed retrospectively) and during the baseline period.
•Is on a stable regimen of \= 3 antiepileptic drugs (AEDs), has been on this regimen for at least 5 weeks prior to study enrollment, and maintains this regimen throughout the participation in the study.

•To be eligible for inclusion into this study, the patient must not meet any of the following criteria prior to enrollment
•Is participating in another clinical study at the time of this study, or has participated in another study within 30 days prior to signing the informed consent form.
•Is pregnant or breast\-feeding.
•Is a sexually active female of child\-bearing potential unless she is using a reliable, medically\-approved primary\-form of birth control. At the discretion of the investigator, total abstinence from sexual intercourse is acceptable in those cases where the age, career, lifestyle or sexual orientation of the patient ensures the prevention of a pregnancy.
•Is an employee of the investigational site directly affiliated with this study and/or their immediate family members, an employee of the sponsor or the clinical research organization.
•Is unwilling or unable to adhere to all study requirements, including accurate completion of the patient diary and questionnaires at the required time points and attending all study visits.
•Is unable to understand the study plan, its conditions, the therapy goals and expected outcomes.
•Has a substance use disorder (DSM\-IV).
•Has a major psychiatric disorder (Diagnostic and Statistics Manual of Mental Disorders), such as major depressive disorder or schizophrenia.
•Has a deteriorating neurological or medical condition, including for example cerebrovascular degeneration or structural damage to basal ganglia.