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Recruiting Not applicable NCT06450444

The RECLAIM Study.

No applicable phase (e.g. observational)
Conditions: Chronic Migraine High Frequency Episodic Migraine

Sponsor: Salvia BioElectronics

trial.available_in: БГ
Overview
The purpose of this study is to evaluate the safety and performance, including clinical benefit, of the PRIMUS System for the treatment of Resistant Migraine.
Who can participate
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 year prior to screening * Failure of 3 or more preventive pharmacological therapies * Stable on preventive migraine treatments * Psychologically stable 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 3 months. * Use of local corticosteroid injections in the occipital or supra-orbital region in the past 3 months prior to enrollment. * Not pregnant, nursing or not using contraception
Locations 3
Australia (1)
Genesis Research Services
Broadmeadow , New South Wales
ACTIVE_NOT_RECRUITING
Belgium (1)
ZAS Antwerpen, Campus Sint-Augustinus
Wilrijk , Antwerpen
Netherlands (1)
St. Antonius Nieuwegein
Nieuwegein
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
84 Years
Healthy volunteers
No
Start date
24.06.2024
Completion date
31.01.2029
Registry ID
NCT06450444
Source
anzctr
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