Abortive Treatment of Migraine With the Cefaly® Abortive Program Device

Study Overview
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Brief Summary
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The purpose of this study is to investigate the efficacy of the Cefaly® Abortive Program device used at home for 2 hours to treat a migraine attack. This open clinical trial will study the abortive treatment of migraine using the Cefaly® Abortive Program device, prior to development of a sham-controlled trial.

Detailed Description
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The main objective of this study is to have a pilot assessment of the efficacy of the Cefaly® Abortive Program device used at home for 2 hours to treat a migraine attack, as triptans are generally used. That is to say having pilot data to assess the efficacy of the Cefaly® Abortive Program device in the abortive treatment of acute migraine as measured by 2-hour pain freedom, pain relief and migraine associated symptoms freedom, plus evolution of these measurements for 24 hours after the beginning of the treatment session.

Official Title
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Abortive Treatment of Migraine With the Cefaly® Abortive Program Device: Pilot Trial

Conditions
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Migraine

Intervention / Treatment
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* Device: Cefaly® Abortive Program device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age from 18 to 65 years on the day of signing the informed consent form ≥ 1-year history of migraine with or without aura according to the diagnostic criteria listed in the International Classification of Headache Disorders (ICHD)-III beta (2013) section 1, migraine (8), with the exception of aura without headache, hemiplegic migraine and brainstem aura migraine Migraine onset before the age of 50 years Having between 2 and 8 moderate or severe migraine attacks (Grade 2 or 3) per month in each of the two months prior to screening Patient understands the study procedures, alternative treatments available, and voluntarily agrees to participate in the study by giving written informed consent Patient is able to read and understand the written information (instruction sheet, paper diary and Adverse Events (AE) collecting form) Exclusion Criteria: Patient has difficulty distinguishing his/her migraine attacks from tension-type headaches Patient has more than 15 headache days per month Patient having received supraorbital nerve blocks in the prior 4 months Patient having received Botox treatment in the prior 4 months Modification of a migraine prophylaxis treatment in the previous 3 months Diagnosis of other primary headache disorders, except rare (< 4) tension-type headaches per month Diagnosis of secondary headache disorders included Medication Overuse Headache Patients abusing opioids or user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence Implanted metallic or electronic device in the head Cardiac pacemaker or implanted or wearable defibrillator Patient having had a previous experience with the Cefaly® device Migraine Aura without headache Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of screening visit (Visit 1) Patients not having the ability to use appropriately the device and/or to perform themselves or bear the first 20-minute stimulation session during the training session at the study site

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>120 minutes of Cefaly® Abortive Program device stimulation as abortive treatment of an early stage migraine attack | Device: Cefaly® Abortive Program device<br>* The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Freedom (PF) at 2 Hours | The percentage of patients having a reduction of a moderate or severe migraine headache (Grade 2 or 3) at baseline to no headache (Grade 0) at 2 hours after the beginning of the e-TNS session. | 2 hours | 
| Most Bothersome Migraine-associated Symptom (MBS) Freedom at 2 Hours | The percentage of patients with absence, at 2 hours after the beginning of the e-TNS session, of the most bothersome migraine-associated symptom identified at baseline. | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Relief (PR) at 2 Hours | The percentage of patients having a reduction of a moderate or severe migraine headache (Grade 2 or 3) at baseline to a mild headache or to no headache (Grade 1 or 0) at 2 hours after the beginning of the e-TNS session. | 2 hours | 
| Migraine-associated Symptoms Freedom at 2 Hours | The percentage of patients with absence of photophobia, phonophobia, nausea and vomiting, at 2 hours after the beginning of the e-TNS session. | 2 hours | 
| Use of Rescue Medication Between 2 and 24 Hours | The percentage of patients who took acute anti-migraine medication between 2 and 24 hours after the beginning of the e-TNS session. | Between 2 and 24 hours | 
| Sustained Pain Freedom at 24 Hours | The percentage of patients having no headache (Grade 0) at 2 hours, with no use of rescue medication and no relapse of headache pain within the 24 hours after the beginning of the e-TNS session. | 24 hours |