PBASE-system Acute Migraine Clinical Investigation

Chordate Medical

Status

Terminated

Conditions

Acute Migraine

Treatments

Device: PBASE-system 2.0

Study type

Interventional

Funder types

Industry

Identifiers

NCT01680029

PM001

Details and patient eligibility

About

To evaluate the performance and safety of the PBASE-system when used in the treatment of acute migraine episodes of moderate to severe intensity. The study will evaluate the effect of treatment on migraine pain and symptoms during an acute attack and also any long-term effect.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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