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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	German Clinical Trials Register
Last refreshed on:	8 April 2024
Main ID:	DRKS00012584
Date of registration:	29/06/2017
Prospective Registration:	Yes
Primary sponsor:	Epilepsiezentrum Kork
Public title:	Therapeutic range of Brivaracetam, a historical observational study to define a therapeutic range
Scientific title:	Therapeutic range of Brivaracetam, a historical observational study to define a therapeutic range
Date of first enrolment:	03/07/2017
Target sample size:	200
Recruitment status:	Pending
URL:	http://drks.de/search/en/trial/DRKS00012584
Study type:	observational
Study design:	Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: other
Phase:

Countries of recruitment
Germany

Contacts

Name:	Tassanai Intravooth
Address:	Landstraße 1 77694 Kehl Germany
Telephone:	07851-842272
Email:	tintravooth@epilepsiezentrum.de
Affiliation:	Epilepsiezentrum Kork

Name:	Matthias Schneider
Address:	Landstraße 1 77694 Kehl Germany
Telephone:	07851-849123
Email:	maschneider@epilepsiezentrum.de
Affiliation:	Epilepsiezentrum Kork

Key inclusion & exclusion criteria

Inclusion criteria: Retrospective analysis of already available data during the period of 01.03.2016 - 15.05.2017 of patients with age between 18 and 89 years and a diagnosis of epilepsy and a treatment of brivaracetam
Exclusion criteria: 1. Healthy volunteers
2. Data from the following patients will NOT be collected: minors, mentally disabled patients, dementia patients, pregnant women, breastfeeding or emergency patients.

Age minimum: 18 Years
Age maximum: 89 Years
Gender: All

Health Condition(s) or Problem(s) studied

G40.2

Localization-related (focal)(partial) symptomatic epilepsy and epileptic syndromes with complex partial seizures

G40.2
G40

Epilepsy

Intervention(s)

Group 1: Retrospective analysis of already available data of patients with age between 18 and 89 years and a diagnosis of epilepsy and a treatment of brivaracetam

Primary Outcome(s)

The aim of the study is to find out whether a therapeutic range of brivaracetam exists by examining the following parameters:

1. Serum concentration of brivaracetam which reduces the seizure attack by at least 50% over a period of at least 3 months.

2. Serum concentration of brivaracetam which lead to a documentation of the two most common neurotoxic side effects, which are fatigue and / or dizziness.

Secondary Outcome(s)

not applicable

Secondary ID(s)

Source(s) of Monetary Support

Epilepsiezentrum Kork

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 23/05/2017
Contact:

ekfr.mpg@uniklinik-freiburg.de

Ethik-Kommission der Albert-Ludwigs-Universität Freiburg

+49-761-27072600

ekfr.mpg@uniklinik-freiburg.de

Results

Results available:
Date Posted:
Date Completed:
URL:	http://drks.de/search/en/trial/DRKS00012584#studyResults

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