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A Randomized, Placebo-controlled, Double-blind, Multi-center Clinical Investigation to Evaluate the Performance and Safety of the Chordate System When Used in the Treatment of Acute Migraine Attacks of Moderate to Severe Intensity
The main purpose of the study is to evaluate the impact of treatment with the Chordate System S020 (medical device) on acute migraine headache pain.
One single migraine attack will be treated either with the Chordate System S020 or with Chordate System in placebo mode. After a screening visit, up to 3 months before treatment, eligible subjects will be asked to return to the center at the onset of their next moderate to severe migraine attack. Subjects will be re-checked for eligibility, randomized and treated at the center (treatment visit). The subjects will record their response over the next 48 hours using a diary card. A follow-up visit will be scheduled 3 to 7 days after the treatment. In addition the subjects will be contacted within 24 to 48 hours after treatment initiation via a telephone contact to discuss their health including new or ongoing AEs.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Universitätsklinikum Tübingen / Zentrum für Neurologie
Tübingen, Baden-Wurttemberg, Germany
Praxis für Neurologie und Psychiatrie, Psychotherapie, Schmerztherapie
Erding, Bavaria, Germany
Neurologie- & Kopfschmerzzentrum
München, Bavaria, Germany
Klinikum Großhadern / Neurologische Klinik der Universität München
München, Bavaria, Germany
Universitätsklinikum Eppendorf
Hamburg, Hamburg, Germany
Migräne-Klinik Königstein
Königstein im Taunus, Hesse, Germany
Universitätsklinikum Essen / Neurologische Klinik
Essen, North Rhine-Westphalia, Germany
Praxis für spezielle Schmerztherapie
Wegberg, North Rhine-Westphalia, Germany
Charité - Universitätsmedizin Berlin / Campus Mitte Klinik für Neurologie
Berlin, State of Berlin, Germany
Start Date
July 1, 2014
Primary Completion Date
July 1, 2015
Completion Date
July 1, 2015
Last Updated
August 5, 2015
51
ACTUAL participants
Chordate System S020 in treatment mode
DEVICE
Chordate System S020 in placebo mode
DEVICE
Lead Sponsor
Chordate Medical
NCT02745392
NCT01730326
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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.
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