Abortive Treatment of Migraine With the Cefaly® Abortive Program Device

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.

• Cefaly® Abortive Program device (Device): The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS).

Primary outcomes

• Pain Freedom (PF) at 2 Hours [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.
• Most Bothersome Migraine-associated Symptom (MBS) Freedom at 2 Hours [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.

Secondary outcomes

• Pain Relief (PR) at 2 Hours [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.
• Migraine-associated Symptoms Freedom at 2 Hours [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.
• Use of Rescue Medication Between 2 and 24 Hours [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.
• Sustained Pain Freedom at 24 Hours [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.

Sex: All, ages: 18 Years to 65 Years

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

Participant flow

Outcome results

• Pain Freedom (PF) at 2 Hours (Primary), Count of participants, Participants: Active 17
• Most Bothersome Migraine-associated Symptom (MBS) Freedom at 2 Hours (Primary), Count of participants, Participants: Active 29
• Pain Relief (PR) at 2 Hours (Secondary), Count of participants, Participants: Active 34
• Migraine-associated Symptoms Freedom at 2 Hours (Secondary), Count of participants, Participants: Active 22
• Use of Rescue Medication Between 2 and 24 Hours (Secondary), Count of participants, Participants: Active 24
• Sustained Pain Freedom at 24 Hours (Secondary), Count of participants, Participants: Active 12

Adverse events

Time frame: The data was collected during the 24 hours following the start of the treatment

Other adverse events by term

• Study Protocol and Statistical Analysis Plan (PDF, 2017-06-01)

• Joseph MANN, M.D., Principal investigator, Rochester Clinical Research