PBASE-system Acute Migraine Clinical Investigation

Inclusion Criteria: * Willing and able to provide written informed consent prior to participation in the clinical investigation * Male or female aged between 18 and 65 years * Diagnosed as suffering from migraine with or without aura according to IHS classification (ICHD-II) * Reported history of 2 to 6 migraine episodes per month during previous 3 months, confirmed during a prospective baseline period of one month * Reported history of no less than 50% of migraine episodes involving moderate or severe pain intensity, confirmed during a prospective baseline period of one month * Reported history of at least 48 hours of freedom from headache between migraine attacks, confirmed during a prospective baseline period of one month * Reported history of the majority of untreated migraine attack durations lasting 8 hours or more * Onset of migraine headache occured before age 50 * Reported history of migraine for more than one year * Able and willing to maintain current preventive headache medication regimen(s) (no change in type, frequency or dose) from baseline screening visit to 2 weeks post-treatment * Able to understand and complete the electronic diary * Experiencing an acute migraine attack of moderate to severe pain intensity at the time of treatment * Treatment is possible within 5 hours of migraine onset Exclusion Criteria: * Reported history of 15 or more headache days per month (i.e. headaches of any kind), confirmed during a prospective baseline period of one month * Reported frequency of non-migraine headaches exceeding 6 days per month, confirmed during a prospective baseline period of one month * Unable to distinguish between migraine headaches and other headache types at the onset of a migraine attack * Treatment with Botox received within 6 months of the screening visit, or between the screening and treatment visit * Previously treated with an implantable stimulator or any implantable devices in the head and/or neck * Diagnosed as having a pronounced anterior septal deviation * History of sinus surgery, transphenoidal surgery for pituitary or other lesions or CSF rhinorrhea * Fitted with a pacemaker /defibrillator * Previously treated with radiation to the face * Ongoing bacterial infection in the nasal cavity * History of nose bleeds (epistaxis) * Ongoing malignancy in the nasal cavity * Concomitant condition that could cause excessive bleeding * Known allergy to polyvinylchloride,the material used for fabrication of the balloon part of Catheter A100, or medicinal liquid paraffin * Concurrent condition or risk of non-compliance that, in the investigator's opinion, may affect the interpretation of performance or safety data or which otherwise contraindicates participation in a clinical investigation * Any change in migraine prophylaxis between the screening and treatment visit * Women of childbearing potential who is pregnant or at risk of becoming pregnant prior to or during the treatment phase * Participation in a clinical research study within 3 months of enrolment or planned participation at any time during this clinical investigation * Considered to meet the definition of vulnerable in the Investigator's opinion * Headache or migraine episode within the 48 hours prior to treatment * PRN (as required) or acute migraine medication(s) taken within the 48 hours prior to treatment