Clinical Trial

Biochemical Profiling of Migraine Patients

Study acronym: SPHERA_WP1_1

Recruiting

Record status

This record was last updated September 5, 2024 (before its estimated February 2026 completion). Its status may not reflect the trial's current state.

Summary

Aim of the study was to assess a potential dysfunction of the endocannabidiome system (eCBome) in migraine patients. Migraine patients who will undergo preventive therapy with monoclonal antibodies directed against the calcitonin gene related peptide (mAbs) will be evaluated through a deep phenotyping of peripheral neurochemical biomarkers (eCBome, neuropeptides, cytokines and kynurenine levels, and microRNAs expression). Primary aim is to assess baseline differences among those patients who achieved a reduction of monthly migraine days \>/= 50% after three months of tretament (namely Responders) and those who did not (namely Non-responders).

Protocol Amendment History 2 amendments

This ClinicalTrials.gov record has been amended 2 times since 2024-08-08; most recent amendment 2024-09-01.

Trial Details

NCT Number	NCT06549270
Lead Sponsor	IRCCS National Neurological Institute "C. Mondino" Foundation Collaborators: University of L'Aquila
Conditions	Migraine Disorders, Chronic Migraine, Episodic Migraine
Enrollment	100 participants
Start Date	2023-05-10
Primary Completion	2026-02 (estimated)
Study Completion	2026-05 (estimated)
Updated on ClinicalTrials.gov	2024-09-05