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NCT05046119
Psychological and Biological Markers of Refractory Migraine
trial in Migraine in 80 participants. Status unknown.
15 September 2024
Quick facts
| Lead sponsor | IRCCS National Neurological Institute "C. Mondino" Foundation |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 80 |
| Start date | 15 September 2021 |
| Primary completion | 15 September 2024 |
| Estimated completion | 15 September 2024 |
| Sites | 1 location across Italy |
Conditions studied
- Migraine — all drugs for Migraine →
Sponsor
IRCCS National Neurological Institute "C. Mondino" Foundation
Who can join
Adults 18 to 65, any sex, with Migraine. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The term "refractory" migraine describes a particularly aggressive form of the disease in which the patient does not benefit from any of the preventive therapies with the various classes of drugs available, including treatment with monoclonal antibodies directed against Calcitonin Gene Related Peptide (CGRP). Anxiety, depressive symptoms, somatization, and pain hypersensitivity are significantly more prevalent in refractory migraineurs than in non-refractory subjects who benefit from preventive therapies, suggesting that these symptoms may contribute to treatment refractoriness. Recently, in a preliminary study on the efficacy of a CGRP-targeting monoclonal antibody in Chronic Migraine (CM) patients with at least 3 failures to previous preventive treatments, the investigators showed a higher prevalence of psychological disturbances in those who did respond to the monoclonal antibody compared with the responders. These data, although preliminary, point to a more psychologically complicated picture in non-responder patients compared with responders. To date, however, no neurobiological evaluations are available to explain how psychological comorbidities may contribute to treatment refractoriness. Isolated clinical evidence and growing pre-clinical evidence suggests a role for the endocannabinoid system in migraine. Hence, the present study aims to identify psychological and biological factors associated with refractory migraine. The investigators' hypothesis is that patients presenting with psychological disorders may bear an associated dysfunction of the endocannabinoid system, which makes them more resistant to migraine preventive therapies, including monoclonal antibodies directed against CGRP.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Peripheral Endocannabinoid Components and Lipid Plasma Levels in Patients with Resistant Migraine and Co-Morbid Personality and Psychological Disorders: A Cross-Sectional Study.
Bottiroli S, Greco R, Franco V, Zanaboni A, et al · · 2024 · cited 2× · PMID 38339171 · DOI 10.3390/ijms25031893
Verify or expand the search:
- PubMed search for NCT05046119
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other IRCCS National Neurological Institute "C. Mondino" Foundation trials
Trials by the same sponsor.
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- NCT07442916 — Non-Invasive Brain Stimulation as Add-on Treatment in Chronic Migraine With Medication Overuse · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05046119 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by IRCCS National Neurological Institute "C. Mondino" Foundation
- Last refreshed: 16 September 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05046119.
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