Clinical trial NCT02185703: Chordate System S020 Acute Migraine Clinical Investigation
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Migraine
Lead sponsor: Chordate Medical
Sponsor class: INDUSTRY
First posted: 2014-07-09
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Headache relief
timeFrame: 2 hours after treatment initiation
Secondary outcomes:
measure: Pain-free rate
timeFrame: 2 hours after treatment initiation
measure: Incidence of recurrence
timeFrame: 48 hours after treatment initiation
measure: 24 hour sustained pain-free rate
timeFrame: 24 hours after treatment initiation
measure: 48 hour sustained pain-free rate
timeFrame: 48 hours after treatment initiation
measure: Time to meaningful relief
timeFrame: 4 hours post-treatment initiation
measure: Change in nausea, photophobia, phonophobia, vomiting and disability
timeFrame: 2 hours post-treatment initiation
measure: Subject global impression
timeFrame: 48 hours post-treatment initiation.
measure: Use of rescue medication
timeFrame: 48 hours post-treatment initiation
measure: Frequency, severity, device-relationship and outcome of all adverse events
timeFrame: 48 hours post-treatment initiation
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen / Zentrum für Neurologie
state: Baden-Württemberg
city: Erding
country: Germany
facility: Praxis für Neurologie und Psychiatrie, Psychotherapie, Schmerztherapie
state: Bayern
city: München
country: Germany
facility: Neurologie- & Kopfschmerzzentrum
state: Bayern
city: München
country: Germany
facility: Klinikum Großhadern / Neurologische Klinik der Universität München
state: Bayern
city: Konigstein im Taunus
country: Germany
facility: Migräne-Klinik Königstein
state: Hessen
city: Essen
country: Germany
facility: Universitätsklinikum Essen / Neurologische Klinik
state: Nordrhein-Westfalen
city: Wegberg
country: Germany
facility: Praxis für spezielle Schmerztherapie
state: Nordrhein-Westfalen
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin / Campus Mitte Klinik für Neurologie
city: Hamburg
country: Germany
facility: Universitätsklinikum Eppendorf
Study officials:
affiliation: Universitätsklinikum Essen
name: Hans-Christoph Diener, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: