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New treatment option for Chronic Migraine
Official title The RECLAIM Study.
ClinicalTrials.gov ID: NCT06450444
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 84
You may be able to join if
- Diagnosis of migraine as defined by the ICHD-3 Classification (with or without aura) with a history of chronic or high-frequency episodic migraine...
- Failure of 3 or more preventive pharmacological therapies
- Stable on preventive migraine treatments
- Psychologically stable
You likely can't join if
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Broadmeadow, New South Wales, Australia
- Buderim, Queensland, Australia
- Wilrijk, Antwerpen, Belgium
- Hasselt, Limburg, Belgium
- Saint-Nicolas, Liège, Belgium
- Bruges, West Vlaanderen, Belgium
- Kortrijk, West Vlaanderen, Belgium
- Ostend, West Vlaanderen, Belgium
- Roeselare, West Vlaanderen, Belgium
- Nieuwegein, Netherlands
- Rotterdam, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 84 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Broadmeadow, New South Wales, Australia; Buderim, Queensland, Australia; Wilrijk, Antwerpen, Belgium; Hasselt, Limburg, Belgium; Saint-Nicolas, Liège, Belgium; Bruges, West Vlaanderen, Belgium and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.