The RECLAIM Study.

Salvia BioElectronics62 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Chronic Migraine High Frequency Episodic Migraine

Interventions

PRIMUSDEVICE

The Salvia PRIMUS System is designed to provide subcutaneous neurostimulation to the branches of the trigeminal and occipital nerves.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 84 Years

Medical Language ↔ Plain English

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

Locations (8)

Genesis Research Services

Broadmeadow, New South Wales, Australia

ACTIVE_NOT_RECRUITING

Resolve Pain

Buderim, Queensland, Australia

ACTIVE_NOT_RECRUITING

Jessa Hasselt

Hasselt, Limburg, Belgium

Outcomes

Primary Outcomes

Safety Evaluation

The incidence of serious procedure, device and/or stimulation-related adverse events.

Time frame: 12 weeks

Effectiveness Evaluation

Difference between randomization arms, in proportion of subjects with ≥ 30% reduction in the number of Monthly Migraine Days (MMD).

Time frame: 12 weeks

Data from ClinicalTrials.gov

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