A Phase III Trial of e-TNS for the Acute Treatment of Migraine

The main objective of this study is to have Phase III evidences 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 randomized, double-blind, sham-controlled data of the efficacy and safety 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 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 International Classification of Headache Disorders (ICHD)-3 beta (2013) section 1, migraine, with the exception of aura without headache, hemiplegic migraine and brainstem aura migraine
• Migraine onset before the age of 50
• 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 reporting 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 including Medication Overuse Headache (MOH)
• Patient abusing opioids or user of recreational or illicit drugs or having 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 in the last 30 days before the screening visit (Visit 1)
• Patient not having the ability to use appropriately the device and/or to perform himself/herself or bear the first 20-minute stimulation session during the training test session at the study site