Phase
Condition
Oral Facial Pain
Migraine And Cluster Headaches
Migraine (Pediatric)
Treatment
PRIMUS
Clinical Study ID
Ages 18-84 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Diagnosis of migraine as defined by the ICHD-3 Classification (with or without aura)with a history of chronic or high-frequency episodic migraine for at least 1 yearprior to screening
Failure of 3 or more preventive pharmacological therapies
Stable on preventive migraine treatments
Psychologically stable
Exclusion
Exclusion Criteria:
Concomitant invasive or non-invasive neuromodulation
Previous exposure to an implantable neuromodulation device for headache
Have an existing active implantable medical device nearby the implant location (e.g.DBS, cochlear implant)
Use of onabotulinum toxin A injections for the treatment of migraine in the past 3months.
Use of local corticosteroid injections in the occipital or supra-orbital region inthe past 3 months prior to enrollment.
Not pregnant, nursing or not using contraception
Study Design
Connect with a study center
Genesis Research Services
Broadmeadow, New South Wales NSW, 2292
AustraliaSite Not Available
Genesis Research Services
Broadmeadow 10103838, New South Wales 2155400 NSW, 2292
AustraliaSite Not Available
Resolve Pain
Buderim, Queensland 4556
AustraliaSite Not Available
Resolve Pain
Buderim 2173605, Queensland 2152274 4556
AustraliaSite Not Available
Monash House Private Hospital
Clayton, Victoria VIC, 3168
AustraliaSite Not Available
ZAS Antwerpen, Campus Sint-Augustinus
Wilrijk, Antwerpen
BelgiumActive - Recruiting
Jessa Hasselt
Hasselt, Limburg 3500
BelgiumActive - Recruiting
Jessa Hasselt
Hasselt 2796491, Limburg 3500
BelgiumSite Not Available
Private Practice Dr. Sava
Saint-Nicolas, Liège
BelgiumSite Not Available
AZ Sint Jan Brugge
Bruges, West Vlaanderen 8000
BelgiumActive - Recruiting
AZ Sint Jan Brugge
Bruges 2800931, West Vlaanderen 8000
BelgiumSite Not Available
AZ Sint Jan Brugge
Brugge, West Vlaanderen 8000
BelgiumSite Not Available
AZ Groeninge
Kortrijk, West Vlaanderen
BelgiumActive - Recruiting
AZ Oostende
Ostend, West Vlaanderen
BelgiumActive - Recruiting
AZ Delta
Roeselare, West Vlaanderen
BelgiumActive - Recruiting
AZ Delta
Roeselare 2787889,
BelgiumSite Not Available
GZA Ziekenhuizen
Wilrijk,
BelgiumSite Not Available
ZAS Antwerpen, Campus Sint-Augustinus
Wilrijk 2783615,
BelgiumSite Not Available
St. Antonius Nieuwegein
Nieuwegein,
NetherlandsActive - Recruiting
St. Antonius Nieuwegein
Nieuwegein 2750325,
NetherlandsSite Not Available
Erasmus MC Rotterdam
Rotterdam,
NetherlandsActive - Recruiting
Erasmus MC Rotterdam
Rotterdam 2747891,
NetherlandsSite Not Available

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