NCT06549270|Unknown
Biochemical Profiling of Migraine Patients
SPHERA_WP1_1
Unraveling the Spectrum of Migraine Resistant to Treatments: Searching for Novel Biological PHEnotypes and theRApeutic Approaches (SPHERA Project)
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SPHERA_WP1_1
Unraveling the Spectrum of Migraine Resistant to Treatments: Searching for Novel Biological PHEnotypes and theRApeutic Approaches (SPHERA Project)
Sponsor study identifier
observational
100
1 country
1
Study Start
May 10, 2023
Actual (reported)Primary Completion
February 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 10, 2023
Actual (reported)August 8, 2024
Actual (reported)August 12, 2024
Actual (reported)February 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Gene expression of FAAH
Baseline differences in gene expression of fatty acid amide hydrolase (FAAH) in peripheral blood mononuclear cells (PBMC) (continuous variable)
Baseline (T0) - three months of mAbs treatment (T1)
Gene expression of MAGL
Gene expression of Monoacylglycerol lipase (MAGL) in peripheral blood mononuclear cells (PBMC) (continuous variable)
Baseline (T0) - three months of mAbs treatment (T1)
Gene expression of catalyzing enzymes (DAGL, NAPE, NAAA)
Baseline (T0) - three months of mAbs treatment (T1)
Plasma levels of AEA, 2-AG, PEA, OEA
Baseline (T0) - three months of mAbs treatment (T1)
Plasma levels of CGRP, PACAP and VIP
Baseline (T0) - three months of mAbs treatment (T1)
Gene expression of miR-382-5p, miR-34a, miR-30a and miR-155
Baseline (T0) - three months of mAbs treatment (T1)
Plasma levels of IL-1beta, TNF-alpha, IL-4 and IL-10
Baseline (T0) - three months of mAbs treatment (T1)
Patients with high frequency episodic migraine (HFEM) or chronic migraine (CM) undergoing treatment with monoclonal antibodies directed against calcitonin gene related peptide pathway (mAbs) who obtained a reduction in monthly migraine days equal or higher than 50% after three months of treatment compared to pre-treatment values.
Patients with HFEM or CM undergoing mAbs treatment who obtained a reduction in monthly migraine days \< 50% after three months of treatment compared to pre-treatment values.
Monthly or quarterly mAbs administration
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Subjects with chronic or high frequency episodic migraine attending the outpatient clinic of the Headache Science \& Neurorehabilitation Unit of the IRCCS Mondino Foundation (Pavia, Italy) and the Neurology Department of the University of L'Aquila (Avezzano, Italy).
Headache Science & Neurorehabilitation Unit
Pavia, 27100, Italy
Gao W, Walther A, Wekenborg M, Penz M, Kirschbaum C. Determination of endocannabinoids and N-acylethanolamines in human hair with LC-MS/MS and their relation to symptoms of depression, burnout, and anxiety. Talanta. 2020 Sep 1;217:121006. doi: 10.1016/j.talanta.2020.121006. Epub 2020 Apr 9.
Fuertig R, Ceci A, Camus SM, Bezard E, Luippold AH, Hengerer B. LC-MS/MS-based quantification of kynurenine metabolites, tryptophan, monoamines and neopterin in plasma, cerebrospinal fluid and brain. Bioanalysis. 2016 Sep;8(18):1903-17. doi: 10.4155/bio-2016-0111. Epub 2016 Aug 15.
Peripheral blood
First Submitted
August 8, 2024
First Posted
August 12, 2024
Study Start
May 10, 2023
Actual (reported)Primary Completion
February 2026
Estimated (date passed)Neurophysiological and Biomolecular Effects of Atogepant in Episodic Migraine
Contact the study team to confirm eligibility.
Greco R, Demartini C, Zanaboni AM, Tumelero E, Icco R, Sances G, Allena M, Tassorelli C. Peripheral changes of endocannabinoid system components in episodic and chronic migraine patients: A pilot study. Cephalalgia. 2021 Feb;41(2):185-196. doi: 10.1177/0333102420949201. Epub 2020 Sep 23.
De Icco R, Greco R, Demartini C, Vergobbi P, Zanaboni A, Tumelero E, Reggiani A, Realini N, Sances G, Grillo V, Allena M, Tassorelli C. Spinal nociceptive sensitization and plasma palmitoylethanolamide levels during experimentally induced migraine attacks. Pain. 2021 Sep 1;162(9):2376-2385. doi: 10.1097/j.pain.0000000000002223.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 5, 2024
Record last verified: 2024-09
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Source: ClinicalTrials.gov.
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