Assessing biochemical profiles in migraine patients
Unraveling the Spectrum of Migraine Resistant to Treatments: Searching for Novel Biological PHEnotypes and theRApeutic Approaches (SPHERA Project)
This study is testing if certain biological markers can help explain why some people with chronic and episodic migraines respond better to a new preventive treatment than others.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | IRCCS National Neurological Institute "C. Mondino" Foundation Academic / other |
| Locations | 1 site (Pavia) |
| Trial ID | NCT06549270 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the dysfunction of the endocannabinoid system in patients with chronic and episodic migraines. Participants will undergo preventive therapy with monoclonal antibodies targeting calcitonin gene-related peptide and will be assessed for neurochemical biomarkers, including neuropeptides, cytokines, and microRNAs. The primary goal is to compare patients who experience significant reductions in migraine days after treatment with those who do not, identifying potential biomarkers that could explain treatment resistance. This research is part of the SPHERA project and seeks to deepen our understanding of migraine pathophysiology.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 75 with a diagnosis of episodic or chronic migraine who have not previously received CGRP-targeting treatments.
Not a fit: Patients with other primary or secondary headache disorders, significant psychiatric or neurological conditions, or those currently undergoing changes in preventive treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better-targeted treatments for migraine patients who do not respond to current therapies.
How similar studies have performed: While there is evidence of altered endocannabinoid systems in migraine patients, this specific approach to deep phenotyping and biomarker identification is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * male and female patients aged 18 to 75 years * diagnosis of episodic migraine or chronic migraine according to ICHD-3 criteria * for episodic migraine: 8-14 monthly migraine days in the previous 3 months * diagnosis of resistant migraine defined by: i) having failed at least 3 classes of migraine preventatives and ii) suffering from at least 8 debilitating monthly headache days for at least 3 consecutive months * patients naive to CGRP targeting treatments Exclusion Criteria: * history of major psychiatric or other neurological conditions * diagnosis of other primary or secondary headache disorders (only sporadic tension-type headache is allowed if the patients can clearly differentiate between the 2 types of headaches) * changes in ongoing preventive treatment (if any) in the previous 3 months * clinically significant medical conditions * chronic pain conditions * alcohol and/or drug abuse * pregnancy or lactation
Where this trial is running
Pavia
- Headache Science & Neurorehabilitation Unit — Pavia, Italy (Recruiting)
Study contacts
- Study coordinator: Roberto De Icco
- Email: roberto.deicco@mondino.it
- Phone: 00390382380425
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.