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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
PRIMUS
DeviceThe Salvia PRIMUS System is designed to provide subcutaneous neurostimulation to the branches of the trigeminal and occipital nerves.
Treatment groups
110 Participants
are divided into 4 treatment groupsGroup A: Cohort 1 - Treatment GroupExperimental treatment 1 intervention
Group B: Cohort 1 - Control GroupOther 1 intervention
Group C: Cohort 2 - Therapy VExperimental treatment 1 intervention
Group D: Cohort 2 - Therapy DExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety Evaluation
The incidence of serious procedure, device and/or stimulation-related adverse events.
Time frame
12 weeks2
Effectiveness Evaluation
Proportion of subjects with ≥ 30% reduction in the number of Monthly Migraine Days (MMD), in randomized arms.
Time frame
12 weeksSponsors and contacts
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Source ClinicalTrials.gov