RECLAIM v1.0
Research type
Research Study
Full title
Randomized, double-blind, sham-controlled trial to investigate combined occipital and supra-orbital neuromodulation in resistant migraine [RECLAIM Study]
IRAS ID
346296
Contact name
Manjit Matharu
Contact email
Sponsor organisation
Salvia BioElectronics
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
CIV-24-03-046506, EUDAMED
Duration of Study in the UK
2 years, 8 months, 2 days
Research summary
This RECLAIM study is a multi-center, randomized, double-blind, sham-controlled study with an open-label extension phase. The PRIMUS System is an implantable neurostimulator, specifically developed for the stimulation of the nerves of the head.
The purpose of the study is To evaluate the safety and performance, including clinical benefit, of the PRIMUS System for the treatment of Resistant Migraine. Patients with Resistant Migraine, having failed at least 3 drug classes for migraine prevention, and meet all study eligibility criteria will be implanted with the PRIMUS System. After implantation, patients will be randomized 1:1 to either the Treatment or Control arm. During the randomized treatment phase of 12 weeks, patients in the Control group (Sham) will receive no stimulation; patients in the Treatment group will receive active subthreshold stimulation. After the randomized treatment phase, all patients will go to the open-label phase and all patients will receive stimulation. All patients will be followed up for 24 months post-implantation.
The primary objective is to evaluate the proportion of subjects with ≥ 30% reduction in the number of Monthly Migraine Days (MMD) of the Treatment Arm versus the Control Arm.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
24/EE/0277
Date of REC Opinion
28 Jan 2025
REC opinion
Further Information Favourable Opinion