Migraine Clinical Trials

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Unraveling the Spectrum of Migraine Resistant to Treatments: Searching for Novel Biological PHEnotypes and theRApeutic Approaches (SPHERA Project)

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement, Behavioral
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
View:

• 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

Locations
Other Locations
Italy
Headache Science & Neurorehabilitation Unit
RECRUITING
Pavia
Contact Information
Primary
Roberto De Icco
roberto.deicco@mondino.it
00390382380425
Backup
Cinzia Fattore
cinzia.fattore@mondino.it
00390382380385
Time Frame
Start Date: 2023-05-10
Estimated Completion Date: 2026-05
Participants
Target number of participants: 45
Treatments
NON-Responders
Patients with high frequency episodic or chronic migraine who obtained a reduction in monthly migraine days \< 50% after three months of mAbs treatment compared to pre-treatment values.
Partial-Responders
Patients with high frequency episodic or chronic migraine who obtained a reduction in monthly migraine days \> or equal to 50% after six months of mAbs treatment compared to pre-treatment values but still present more than 5 MMDs.
Related Therapeutic Areas
Sponsors
Collaborators: University of L'Aquila
Leads: IRCCS National Neurological Institute C. Mondino Foundation

This content was sourced from clinicaltrials.gov