SPHERA_WP2
Unraveling the Spectrum of Migraine Resistant to Treatments: Searching for Novel Biological PHEnotypes and theRApeutic Approaches (SPHERA Project)
Sponsor study identifier
observational
45
1 country
1
Study Start
May 10, 2023
Actual (reported)Primary Completion
October 2024
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.
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
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)October 2024
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.
Monthly migraine days (MMDs)
MMDs during treatment with PEA or KD (continuous variable)
Baseline (V0), after three months of intervention (V1), after six months of intervention (V2)
Monthly headache days (MHDs)
Baseline (V0), after three months of intervention (V1), after six months of intervention (V2)
Monthly days and doses of acute drug intake
Baseline (V0), after three months of intervention (V1), after six months of intervention (V2)
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.
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.
PEA supplementation (600mg twice a day for three months)
Diet characterized by the following percentages of macronutrients: 65% fat, 27% protein and 8% carbohydrates
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
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.
Peripheral blood
First Submitted
August 8, 2024
First Posted
August 20, 2024
Study Start
May 10, 2023
Actual (reported)Primary Completion
October 2024
Estimated (date passed)Neurophysiological and Biomolecular Effects of Atogepant in Episodic Migraine
Percentage of patients with a 50% reduction in MMDs
Baseline (V0), after three months of intervention (V1), after six months of intervention (V2)
Migraine related disability assessed by means of MIDAS
Baseline (V0), after three months of intervention (V1), after six months of intervention (V2)
Headache impact assessed by means of HIT-6
Baseline (V0), after three months of intervention (V1), after six months of intervention (V2)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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de Almeida Rabello Oliveira M, da Rocha Ataide T, de Oliveira SL, de Melo Lucena AL, de Lira CE, Soares AA, de Almeida CB, Ximenes-da-Silva A. Effects of short-term and long-term treatment with medium- and long-chain triglycerides ketogenic diet on cortical spreading depression in young rats. Neurosci Lett. 2008 Mar 21;434(1):66-70. doi: 10.1016/j.neulet.2008.01.032. Epub 2008 Jan 19.
Bongiovanni D, Benedetto C, Corvisieri S, Del Favero C, Orlandi F, Allais G, Sinigaglia S, Fadda M. Effectiveness of ketogenic diet in treatment of patients with refractory chronic migraine. Neurol Sci. 2021 Sep;42(9):3865-3870. doi: 10.1007/s10072-021-05078-5. Epub 2021 Feb 1.
Di Lorenzo C, Coppola G, Sirianni G, Di Lorenzo G, Bracaglia M, Di Lenola D, Siracusano A, Rossi P, Pierelli F. Migraine improvement during short lasting ketogenesis: a proof-of-concept study. Eur J Neurol. 2015 Jan;22(1):170-7. doi: 10.1111/ene.12550. Epub 2014 Aug 25.
Paulus MP, Stein MB, Simmons AN, Risbrough VB, Halter R, Chaplan SR. The effects of FAAH inhibition on the neural basis of anxiety-related processing in healthy male subjects: a randomized clinical trial. Neuropsychopharmacology. 2021 Apr;46(5):1011-1019. doi: 10.1038/s41386-020-00936-w. Epub 2020 Dec 17.
Deng H, Li W. Monoacylglycerol lipase inhibitors: modulators for lipid metabolism in cancer malignancy, neurological and metabolic disorders. Acta Pharm Sin B. 2020 Apr;10(4):582-602. doi: 10.1016/j.apsb.2019.10.006. Epub 2019 Oct 18.
Chirchiglia D, Cione E, Caroleo MC, Wang M, Di Mizio G, Faedda N, Giacolini T, Siviglia S, Guidetti V, Gallelli L. Effects of Add-On Ultramicronized N-Palmitol Ethanol Amide in Patients Suffering of Migraine With Aura: A Pilot Study. Front Neurol. 2018 Aug 17;9:674. doi: 10.3389/fneur.2018.00674. eCollection 2018.
Papetti L, Sforza G, Tullo G, Alaimo di Loro P, Moavero R, Ursitti F, Ferilli MAN, Tarantino S, Vigevano F, Valeriani M. Tolerability of Palmitoylethanolamide in a Pediatric Population Suffering from Migraine: A Pilot Study. Pain Res Manag. 2020 Apr 24;2020:3938640. doi: 10.1155/2020/3938640. eCollection 2020.
Freitas HR, Isaac AR, Malcher-Lopes R, Diaz BL, Trevenzoli IH, De Melo Reis RA. Polyunsaturated fatty acids and endocannabinoids in health and disease. Nutr Neurosci. 2018 Dec;21(10):695-714. doi: 10.1080/1028415X.2017.1347373. Epub 2017 Jul 7.
Perrotta A, Arce-Leal N, Tassorelli C, Gasperi V, Sances G, Blandini F, Serrao M, Bolla M, Pierelli F, Nappi G, Maccarrone M, Sandrini G. Acute reduction of anandamide-hydrolase (FAAH) activity is coupled with a reduction of nociceptive pathways facilitation in medication-overuse headache subjects after withdrawal treatment. Headache. 2012 Oct;52(9):1350-61. doi: 10.1111/j.1526-4610.2012.02170.x. Epub 2012 Jun 1.
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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