Abortive Treatment of Migraine With the Cefaly® Abortive Program Device
Abortive Treatment of Migraine With the Cefaly® Abortive Program Device
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.
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