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.

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