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