Chordate System S020 Acute Migraine Clinical Investigation

Not Applicable

Terminated

• Conditions: Acute Migraine
• Interventions: Device: Chordate System S020 in treatment mode; Device: Chordate System S020 in placebo mode

• Registration Number: NCT02185703
• Lead Sponsor: Chordate Medical

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-04
• Study First Submitted QC: 2014-07-04
• Study First Posted: 2014-07-09
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-03
• Last Update Posted: 2015-08-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• Subjects with migraine, with or without aura according to International Headache Society (IHS) classification (International Classification of Headache Disorders [ICHD]-III beta).
• History of 1 to 6 migraine attacks per month for at least 12 previous months.
• At least 50% of previous migraine attacks had moderate or severe pain intensity.
• History of at least 48 hours of freedom from headache between migraine attacks.
• The majority of the previous untreated migraine attacks lasted at least 8 hours.
• Migraine onset before the age of 50 years.

Exclusion Criteria

• History (within one year prior to inclusion into this clinical investigation) of 15 or more headache days per month (i.e. headaches of any kind).
• More than 6 days per month with non-migraine headaches (within one year prior to inclusion into this clinical investigation).
• Unable to distinguish between migraine headaches and other headache types at the onset of a migraine attack.
• Treatment with Botox in the head/neck area within 6 months of the screening visit, or between the screening and treatment visit.
• Previously treated with an implantable stimulator or any implantable devices in the head and/or neck.
• Pronounced anterior septal nasal deviation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chordate System S020 in treatment mode	Chordate System S020 in treatment mode	-
Chordate System S020 in placebo mode	Chordate System S020 in placebo mode	-

Primary Outcome Measures

Name	Time	Method
Headache relief	2 hours after treatment initiation	Percentage of subjects with a decrease in migraine headache pain from severe or moderate prior treatment to mild or none at 2 hours after treatment initiation with no use of rescue medication during this time period.

Secondary Outcome Measures

Name	Time	Method
Time to meaningful relief	4 hours post-treatment initiation
Subject global impression	48 hours post-treatment initiation.
Frequency, severity, device-relationship and outcome of all adverse events	48 hours post-treatment initiation
24 hour sustained pain-free rate	24 hours after treatment initiation	percentage of subjects remaining pain-free
Pain-free rate	2 hours after treatment initiation	Percentage of subjects pain-free (pain intensity rated 'No pain') at 2 hours after treatment initiation with no use of rescue medication.
Incidence of recurrence	48 hours after treatment initiation
48 hour sustained pain-free rate	48 hours after treatment initiation	percentage of subjects remaining pain-free
Use of rescue medication	48 hours post-treatment initiation
Change in nausea, photophobia, phonophobia, vomiting and disability	2 hours post-treatment initiation

Trial Locations

Locations (9)

Universitätsklinikum Tübingen / Zentrum für Neurologie; 🇩🇪 Tübingen, Baden-Württemberg, Germany

Neurologie- & Kopfschmerzzentrum; 🇩🇪 München, Bayern, Germany

Klinikum Großhadern / Neurologische Klinik der Universität München; 🇩🇪 München, Bayern, Germany

Migräne-Klinik Königstein; 🇩🇪 Konigstein im Taunus, Hessen, Germany

Universitätsklinikum Essen / Neurologische Klinik; 🇩🇪 Essen, Nordrhein-Westfalen, Germany

Praxis für spezielle Schmerztherapie; 🇩🇪 Wegberg, Nordrhein-Westfalen, Germany

Charité - Universitätsmedizin Berlin / Campus Mitte Klinik für Neurologie; 🇩🇪 Berlin, Germany

Universitätsklinikum Eppendorf; 🇩🇪 Hamburg, Germany

Praxis für Neurologie und Psychiatrie, Psychotherapie, Schmerztherapie; 🇩🇪 Erding, Bayern, Germany