Chronic MigraineRECLAIMNCT06450444
The RECLAIM Study.
A study testing PRIMUS in people with Chronic Migraine and High Frequency Episodic Migraine, run by Salvia BioElectronics at 11 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Chronic Migraine, High Frequency Episodic Migraine
- What is being tested?
- PRIMUS
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 11 sitesin 3 countries
- Study dates
- 24 Jun 2024to 31 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 local corticosteroid injections in the occipital or supra-orbital region in the past 3 months prior to enrollment.
- Not pregnant, nursing or not using contraception
Trial locations and contacts
11 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
11 sites in 3 countries
Belgium7 sites, 6 recruiting
- Recruiting
AZ Sint Jan Brugge
Bruges, West Vlaanderen, 8000
Study Coordinator, +32 50 45 36 96, Liesbeth.Laloo@azsintjan.be
Dr. Van Dycke
- Recruiting
Jessa Hasselt
Hasselt, Limburg, 3500
Plazier, Prof. Dr., +32 (0)11 33 75 70, Mark.Plazier@jessazh.be
- Recruiting
AZ Groeninge
Kortrijk, West Vlaanderen
Dr. Vanhee, +32 56 63 34 20, neurologie@azgroeninge.be
- Recruiting
AZ Oostende
Ostend, West Vlaanderen
Dr. De Pauw, +32 59 41 40 60, neurologie.damiaan@azoostende.be
- Recruiting
AZ Delta
Roeselare, West Vlaanderen
Billet, Dr., 051 23 69 12, ctc.pijn@azdelta.be
- Active, not recruiting
Private Practice Dr. Sava
Saint-Nicolas, Liège
- Recruiting
ZAS Antwerpen, Campus Sint-Augustinus
Wilrijk, Antwerpen
Kelderman, Dr., +32 03 285 28 50, tim.kelderman@zas.be
Australia2 sites
- Terminated
Genesis Research Services
Broadmeadow, New South Wales, NSW, 2292
- Terminated
Resolve Pain
Buderim, Queensland, 4556
Netherlands2 sites, 2 recruiting
- Recruiting
St. Antonius Nieuwegein
Nieuwegein
Study Coordinator, 088 320 88 59, i.lange@antoniusziekenhuis.nl
Dr. Nijhuis
- Recruiting
Erasmus MC Rotterdam
Rotterdam
Dr. Siepman, 06 22331104, t.siepman@erasmusmc.nl
Prof. Huygen
About this study
Official title: Randomized, Double-blind, Controlled Trial to Investigate Combined Occipital and Supra-orbital Neuromodulation in Resistant Migraine. The RECLAIM Study.
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.
- Conditions
- Chronic Migraine, High Frequency Episodic Migraine
- Being tested
- PRIMUS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRIMUSDevice
The Salvia PRIMUS System is designed to provide subcutaneous neurostimulation to the branches of the trigeminal and occipital nerves.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 - Treatment Group | Experimental | Active therapy modality Receives: Device: PRIMUS |
| Cohort 1 - Control Group | Other | Sham therapy Receives: Device: PRIMUS |
| Cohort 2 - Therapy V | Experimental | Active therapy modality Receives: Device: PRIMUS |
| Cohort 2 - Therapy D | Experimental | Active therapy modality Receives: Device: PRIMUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Evaluation
The incidence of serious procedure, device and/or stimulation-related adverse events.
Measured: 12 weeks
Effectiveness Evaluation
Proportion of subjects with ≥ 30% reduction in the number of Monthly Migraine Days (MMD), in randomized arms.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start24 Jun 2024
- Primary completion1 Apr 2027 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Salvia BioElectronics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06450444
- Sponsor's protocol ID
- SCI-03-RM
- Acronym
- RECLAIM
- Status last verified
- Aug 2026
- First submitted
- 4 Jun 2024
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Controlled Trial to Investigate Combined Occipital and Supra-orbital Neuromodulation in Resistant Migraine. The RECLAIM Study.
- ClinicalTrials.gov ID
- NCT06450444
- Acronym / sponsor ID
- RECLAIM / SCI-03-RM
- Conditions
- Chronic Migraine, High Frequency Episodic Migraine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Salvia BioElectronicsIndustry (pharma, biotech, devices)
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 10 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - Treatment Group | Experimental | Device: PRIMUSActive therapy modality |
| Cohort 1 - Control Group | Other | Device: PRIMUSSham therapy |
| Cohort 2 - Therapy V | Experimental | Device: PRIMUSActive therapy modality |
| Cohort 2 - Therapy D | Experimental | Device: PRIMUSActive therapy modality |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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 local corticosteroid injections in the occipital or supra-orbital region in the past 3 months prior to enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRIMUSThe Salvia PRIMUS System is designed to provide subcutaneous neurostimulation to the branches of the trigeminal and occipital nerves. | Device | Cohort 1 - Control Group, Cohort 1 - Treatment Group, Cohort 2 - Therapy D, Cohort 2 - Therapy V |
Primary outcome
Safety Evaluation
Time frame: 12 weeks
The incidence of serious procedure, device and/or stimulation-related adverse events.
Effectiveness Evaluation
Time frame: 12 weeks
Proportion of subjects with ≥ 30% reduction in the number of Monthly Migraine Days (MMD), in randomized arms.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
11 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRIMUS in people with Chronic Migraine and High Frequency Episodic Migraine, run by Salvia BioElectronics at 11 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Belgium, Australia, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Evaluation (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.