Exploring new treatments for migraine patients who don't respond to current therapies
Unraveling the Spectrum of Migraine Resistant to Treatments: Searching for Novel Biological PHEnotypes and theRApeutic Approaches (SPHERA Project)
IRCCS National Neurological Institute "C. Mondino" Foundation · NCT06562400
This study is testing new treatment options for migraine patients who haven't found relief with current therapies to see if they can help reduce their migraine days.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 45 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | IRCCS National Neurological Institute "C. Mondino" Foundation (other) |
| Locations | 1 site (Pavia) |
| Trial ID | NCT06562400 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate novel therapeutic approaches for migraine patients who have not responded to monoclonal antibodies targeting the calcitonin gene-related peptide pathway. The focus is on understanding the dysfunction of the endocannabinoid system in these non-responders and evaluating the clinical, biochemical, and neurofunctional impacts of potential treatments like palmitoyl ethanolamide and a ketogenic diet. Patients will be identified based on their treatment history and the number of migraine days they experience. The study seeks to uncover new pathways for improving migraine management.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 75 with a diagnosis of chronic or episodic migraine who have not responded to at least three classes of migraine preventative treatments.
Not a fit: Patients with major psychiatric or neurological conditions, other primary headache disorders, or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatment options for patients suffering from chronic and episodic migraines who currently have limited relief.
How similar studies have performed: While the approach of targeting the endocannabinoid system in migraine treatment is relatively novel, previous studies have shown promise in normalizing dysfunctions within this system.
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 having failed at least 3 classes of migraine preventatives and suffer 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) * 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.
Conditions: Migraine Disorders, Chronic Migraine, Episodic Migraine, migraine, anti CGRP mABs, calcitonin gene related peptide, endocannabinoid system, HD EEG