The RECLAIM Study.

Launched by SALVIA BIOELECTRONICS · Jun 4, 2024

Keywords

ClinConnect Summary

The RECLAIM Study is a clinical trial that is looking at a new treatment option called the PRIMUS System for people who suffer from chronic migraines or high-frequency episodic migraines. The goal of this study is to see how safe the PRIMUS System is and whether it can help improve the lives of those whose migraines have not responded to other treatments.

To be eligible for the trial, participants must be between 18 and 80 years old and have a history of migraines for at least a year. They should have tried at least three different medications to prevent migraines without success, and they need to be stable on their current migraine treatments. It’s important to note that people with certain conditions, like those who have already used specific migraine devices or treatments recently, may not be able to participate. Those who join the study can expect to be closely monitored and will have the opportunity to help researchers learn more about managing migraines effectively.

Gender

ALL

Eligibility criteria

• 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 steroid infiltrations or IV administration in the past 3 months.
• • Not pregnant, nursing or not using contraception