Chordate System S020 Acute Migraine Clinical Investigation

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Acute Migraine

Intervention / Treatment
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* Device: Chordate System S020 in treatment mode
* Device: Chordate System S020 in placebo mode


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chordate System S020 in treatment mode<br> | Device: Chordate System S020 in treatment mode<br> <br> |
| Sham Comparator: Chordate System S020 in placebo mode<br> | Device: Chordate System S020 in placebo mode<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache relief | 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. | 2 hours after treatment initiation | 

Secondary Outcome Measures

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