Unraveling the Spectrum of Migraine Resistant to Treatments: Searching for Novel Biological PHEnotypes and theRApeutic Approaches (SPHERA Project) (SPHERA_WP1_1)

NCT06549270 RECRUITING

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).

Details

Lead sponsor	IRCCS National Neurological Institute "C. Mondino" Foundation
Status	RECRUITING
Enrolment	100
Start date	2023-05-10
Completion	2026-05

Conditions

• Migraine Disorders
• Chronic Migraine
• Episodic Migraine

Interventions

• MAbs

Primary outcomes

• Gene expression of FAAH — Baseline (T0) - three months of mAbs treatment (T1)
  Baseline differences in gene expression of fatty acid amide hydrolase (FAAH) in peripheral blood mononuclear cells (PBMC) (continuous variable)
• Gene expression of MAGL — Baseline (T0) - three months of mAbs treatment (T1)
  Gene expression of Monoacylglycerol lipase (MAGL) in peripheral blood mononuclear cells (PBMC) (continuous variable)

Countries

Italy