Status:
TERMINATED
Chordate System S020 Acute Migraine Clinical Investigation
Lead Sponsor:
Chordate Medical
Conditions:
Acute Migraine
Eligibility:
All Genders
18-65 years
Phase:
NA
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 wi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT02185703
Start Date
July 1 2014
End Date
July 1 2015
Last Update
August 5 2015
Active Locations (9)
Enter a location and click search to find clinical trials sorted by distance.
1
Universitätsklinikum Tübingen / Zentrum für Neurologie
Tübingen, Baden-Wurttemberg, Germany, 72076
2
Praxis für Neurologie und Psychiatrie, Psychotherapie, Schmerztherapie
Erding, Bavaria, Germany, 85435
3
Neurologie- & Kopfschmerzzentrum
München, Bavaria, Germany, 80802
4
Klinikum Großhadern / Neurologische Klinik der Universität München
München, Bavaria, Germany, 81377