Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
50 participants
INTERVENTIONAL
2013-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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PBASE-system 2.0
PBASE-system 2.0
Interventions
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PBASE-system 2.0
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
65 Years
ALL
No
Sponsors
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Chordate Medical
INDUSTRY
Responsible Party
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Locations
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Glasgow, , United Kingdom
London, , United Kingdom
Stoke-on-Trent, , United Kingdom
Countries
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Other Identifiers
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PM001
Identifier Type: -
Identifier Source: org_study_id