Actively Recruiting
Study to Test PRIMUS Neurostimulation Device for Treating Resistant Chronic and High-Frequency Episodic Migraine in Adults
Led by Salvia BioElectronics · Updated on 2026-08-06
110
Participants Needed
11
Research Sites
95 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and performance of the PRIMUS System, a device designed to provide neurostimulation to branches of the trigeminal and occipital nerves, for treating resistant migraine. The study focuses on patients with chronic or high-frequency episodic migraine who have not responded to multiple preventive drug therapies. It aims to assess clinical benefits and safety over a 12-week period. Participants will be randomly assigned in a double-blind manner to one of several groups including active therapy modalities or sham therapy. The PRIMUS System delivers subcutaneous neurostimulation, and the study compares different therapy approaches to evaluate their effects on migraine symptoms. The study is set to run from June 2024 to January 2029. During the study, participants will be monitored over 12 weeks to evaluate both safety and effectiveness. Researchers will assess clinical outcomes related to migraine treatment, with follow-ups as per study protocols. This period will involve treatment administration and regular evaluations to collect data on responses and any side effects experienced.
CONDITIONS
Brief Title
The RECLAIM Study.
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