SPHERA_WP1_2
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.
The investigators aim to define the neurofunctional phenotype of migraine patients who did not respond to at least 3 preventive treatments, including monoclonal antibodies (mAbs) targeting calcitonin gene-related peptide (CGRP) pathway (NON-responders). Primary aim will be to assess and compare changes in functional resting-state connectivity at baseline and after three months of mAbs treatment between patients who will achieve a reduction of monthly migraine days \>/= than 50% (namely Responders) and those who will not (namely Responders). The 2 groups will undergo a neurofunctional profile by means of High Density-electroencephalogram (HD-EEG) and functional-magnetic resonance imaging (fMRI).
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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Some registry-reported names shown below are not yet linked in this graph.
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 20, 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.
RSN-FC assessed through HD-EEG
Resting state functional connectivity assessed through HD-EEG (continuous variable, without unit of measurement)
Baseline (T0), and three months of mAbs treatment (T1)
RSN-FC assessed through MRI
Resting state functional connectivity assessed through MRI (continuous variable, without unit of measurement)
Baseline (T0)
Comparison between baseline RSN-FC assessed through HD-EEG
Baseline (T0)
Patients with high frequency episodic or chronic migraine 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% compared to pre-treatment values.
Patients with high frequency episodic or chronic migraine undergoing mAbs treatment who obtained a reduction in monthly migraine days \< 50% 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 and 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
Mantini D, Franciotti R, Romani GL, Pizzella V. Improving MEG source localizations: an automated method for complete artifact removal based on independent component analysis. Neuroimage. 2008 Mar 1;40(1):160-73. doi: 10.1016/j.neuroimage.2007.11.022. Epub 2007 Dec 3.
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.
Peripheral blood
First Submitted
August 8, 2024
First Posted
August 20, 2024
Study Start
May 10, 2023
Actual (reported)Primary Completion
February 2026
Estimated (date passed)Neurophysiological and Biomolecular Effects of Atogepant in Episodic Migraine
Comparison between baseline RSN-FC assessed through MRI
Baseline (T0)
Contact the study team to confirm eligibility.
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.
Curto M, Lionetto L, Negro A, Capi M, Fazio F, Giamberardino MA, Simmaco M, Nicoletti F, Martelletti P. Altered kynurenine pathway metabolites in serum of chronic migraine patients. J Headache Pain. 2015;17:47. doi: 10.1186/s10194-016-0638-5. Epub 2016 Apr 29.
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
August 20, 2024
Record last verified: 2024-08
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Source: ClinicalTrials.gov.
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