The RECLAIM Study.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-84
SponsorSalvia BioElectronics
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- PRIMUS
Treatment groups
110 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov