Chronic Migraine Clinical Trial
— RECLAIMOfficial title:
Randomized, Double-blind, Sham-controlled Trial to Investigate Combined Occipital and Supra-orbital Neuromodulation in Resistant Migraine. The RECLAIM Study.
Verified date | June 2024 |
Source | Salvia BioElectronics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 62 |
Est. completion date | February 1, 2027 |
Est. primary completion date | October 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 84 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | AZ Delta | Roeselare | |
Belgium | GZA Ziekenhuizen | Wilrijk |
Lead Sponsor | Collaborator |
---|---|
Salvia BioElectronics |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety Evaluation | The incidence of serious procedure, device and/or stimulation-related adverse events. | 12 weeks | |
Primary | Effectiveness Evaluation | Difference between randomization arms, in proportion of subjects with = 30% reduction in the number of Monthly Migraine Days (MMD). | 12 weeks |
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