NCT06562400 Searching for Novel Therapeutic Approaches in Migraine Patients Resistant to Treatments
| NCT ID | NCT06562400 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS National Neurological Institute "C. Mondino" Foundation |
| Condition | Migraine Disorders |
| Study Type | OBSERVATIONAL |
| Enrollment | 45 participants |
| Start Date | 2023-05-10 |
| Primary Completion | 2024-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 45 participants in total. It began in 2023-05-10 with a primary completion date of 2024-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Primary working hypothesis is that NON-responders to mAbs bear a dysfunction of the endocannabidiome system (eCBome), as suggested by pre-clinical and clinical data by our group. They will be identified as patients showing a reduction of monthly migraine days \< 50% after three months of treatment. The clinical, biochemical and neurofunctional impact of novel therapeutic approaches expected to interfere with eCBome will be evaluated in NON-responder patients
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06562400 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Migraine Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06562400 currently recruiting?
Yes, NCT06562400 is actively recruiting participants. Contact the research team at roberto.deicco@mondino.it for enrollment information.
Where is the NCT06562400 trial being conducted?
This trial is being conducted at Pavia, Italy.
Who is sponsoring the NCT06562400 clinical trial?
NCT06562400 is sponsored by IRCCS National Neurological Institute "C. Mondino" Foundation. The trial plans to enroll 45 participants.
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