The RECLAIM Study.

Not Applicable

Recruiting

• Conditions: High Frequency Episodic Migraine; Chronic Migraine
• Interventions: Device: PRIMUS

• Registration Number: NCT06450444
• Lead Sponsor: Salvia BioElectronics

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-04
• Study First Submitted QC: 2024-06-04
• Study First Posted: 2024-06-10
• Study Start: 2024-06-24
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-25
• Primary Completion: 2025-10-01
• Study Completion: 2027-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group	PRIMUS	Active Stimulation
Control Group	PRIMUS	Sham stimulation

Primary Outcome Measures

Name	Time	Method
Safety Evaluation	12 weeks	The incidence of serious procedure, device and/or stimulation-related adverse events.
Effectiveness Evaluation	12 weeks	Difference between randomization arms, in proportion of subjects with ≥ 30% reduction in the number of Monthly Migraine Days (MMD).

Trial Locations

Locations (9)

Genesis Research Services; 🇦🇺 Broadmeadow, New South Wales, Australia

Resolve Pain; 🇦🇺 Buderim, Queensland, Australia

Monash House Private Hospital; 🇦🇺 Clayton, Victoria, Australia

Jessa Hasselt; 🇧🇪 Hasselt, Limburg, Belgium

AZ Sint Jan Brugge; 🇧🇪 Brugge, West Vlaanderen, Belgium

AZ Delta; 🇧🇪 Roeselare, Belgium

ZAS Antwerpen, Campus Sint-Augustinus; 🇧🇪 Wilrijk, Belgium

St. Antonius Nieuwegein; 🇳🇱 Nieuwegein, Netherlands

Erasmus MC Rotterdam; 🇳🇱 Rotterdam, Netherlands