NCT04324710|Completed
Gene Expression of Endocannabinoid System in Episodic and Chronic Migraine Patients
Peripheral Gene Expression of Endocannabinoid System Components in Episodic and Chronic Migraine Patients: a Pilot Study
Loading search results
Peripheral Gene Expression of Endocannabinoid System Components in Episodic and Chronic Migraine Patients: a Pilot Study
Sponsor study identifier
observational
75
1 country
1
Study Start
December 12, 2017
Actual (reported)Primary Completion
December 31, 2019
Actual (reported)Study Completion
December 31, 2019
Actual (reported)Preclinical and clinical evidence suggests a role for the dysregulation of endocannabinoid system (ES) in migraine pain, particularly in subjects with chronic migraine. The gene expression of ES components were assayed in peripheral blood mononuclear cells (PBMCs) of patients with episodic migraine (EM), chronic migraine with medication overuse (CM-MO) and age-matched healthy controls (CT). It was evaluated the protein expression of cannabinoid receptors (CB) 1 and 2 as well as DNA methylation changes in genes involved in ES components.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2019
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 12, 2017
Actual (reported)December 31, 2019
Actual (reported)December 31, 2019
Actual (reported)March 25, 2020
Actual (reported)March 27, 2020
Actual (reported)CB1 (endocannabinoid receptor) protein expression
CB1 protein expression in the peripheral blood mononuclear cells (PBMCs)
At the time of enrollment
CB2 (endocannabinoid receptor) protein expression
CB2 protein expression in the peripheral blood mononuclear cells (PBMCs)
At the time of enrollment
Gene Expression of the CB receptors
Gene expression of the endocannabinoid receptors in the peripheral blood mononuclear cells ( PBMCs)
At the time of enrollment
Gene Expression of the fatty acid amide hydrolase (FAAH)
Gene expression of the FAAH in the peripheral blood mononuclear cells ( PBMCs)
At the time of enrollment
Gene Expression of the N-acylphosphatidylethanolamide-phospholipase D (NAPE-PLD)
Gene expression of the NAPE-PLD in the peripheral blood mononuclear cells ( PBMCs)
At the time of enrollment
Patients with episodic migraine (EM), chronic migraine with medication overuse (CM-MO) and age-matched healthy controls (CT).
Ircss Mondino Foundation
Pavia, 27100, Italy
Basavarajappa BS, Nixon RA, Arancio O. Endocannabinoid system: emerging role from neurodevelopment to neurodegeneration. Mini Rev Med Chem. 2009 Apr;9(4):448-62. doi: 10.2174/138955709787847921.
Greco R, Demartini C, Zanaboni AM, Piomelli D, Tassorelli C. Endocannabinoid System and Migraine Pain: An Update. Front Neurosci. 2018 Mar 19;12:172. doi: 10.3389/fnins.2018.00172. eCollection 2018.
Since PBMCs contain the full complement of epigenetic enzymes found in most tissues, the investigators evaluated the role of DNA methylation in the regulation of ES gene transcription in all the enrolled subjects. DNA was extracted from whole blood using QIAmp DNA Blood Mini Kit and its concentration was determined by NanoDrop quantification. Arrays preparation and data analysis were performed by Genomix4Life srl. High-quality DNA (500 ng) was bisulfite converted using EZ DNA methylation kit. Bisulfite converted DNA (200ng) was used for analysis of whole-genome methylation, using the HumanMethylation 450 K BeadChip, which contains 485 577 probes covering 21 231 (99%) RefSeq genes.
Cristina Tassorelli, MD
IRCCS MONDINO FOUNDATION
75 participants (actual enrollment reported by the registry).
First Submitted
March 25, 2020
First Posted
March 27, 2020
Study Start
December 12, 2017
Actual (reported)Efficacy and Safety of IONIS-PKKRx for Preventive Treatment of Chronic Migraine
Gene Expression of the diacylglycerol lipase (DAGL)
Gene expression of the DAGL in the peripheral blood mononuclear cells ( PBMCs)
At the time of enrollment
Gene Expression of the monoacylglycerol lipase (MAGL).
Gene expression of the MAGL in the peripheral blood mononuclear cells ( PBMCs)
At the time of enrollment
DNA methylation of endocannabinoid system (ES) components
DNA methylation in the regulation of ES gene transcription
At the time of enrollment
Contact the study team to confirm eligibility.
Greco R, Demartini C, Zanaboni AM, Tumelero E, Reggiani A, Misto A, Piomelli D, Tassorelli C. FAAH inhibition as a preventive treatment for migraine: A pre-clinical study. Neurobiol Dis. 2020 Feb;134:104624. doi: 10.1016/j.nbd.2019.104624. Epub 2019 Oct 17.
La Porta C, Bura SA, Llorente-Onaindia J, Pastor A, Navarrete F, Garcia-Gutierrez MS, De la Torre R, Manzanares J, Monfort J, Maldonado R. Role of the endocannabinoid system in the emotional manifestations of osteoarthritis pain. Pain. 2015 Oct;156(10):2001-2012. doi: 10.1097/j.pain.0000000000000260.
Centonze D, Battistini L, Maccarrone M. The endocannabinoid system in peripheral lymphocytes as a mirror of neuroinflammatory diseases. Curr Pharm Des. 2008;14(23):2370-42. doi: 10.2174/138161208785740018.
Sarchielli P, Pini LA, Coppola F, Rossi C, Baldi A, Mancini ML, Calabresi P. Endocannabinoids in chronic migraine: CSF findings suggest a system failure. Neuropsychopharmacology. 2007 Jun;32(6):1384-90. doi: 10.1038/sj.npp.1301246. Epub 2006 Nov 22.
Arosio B, Bulbarelli A, Bastias Candia S, Lonati E, Mastronardi L, Romualdi P, Candeletti S, Gussago C, Galimberti D, Scarpini E, Dell'Osso B, Altamura C, MacCarrone M, Bergamaschini L, D'Addario C, Mari D. Pin1 contribution to Alzheimer's disease: transcriptional and epigenetic mechanisms in patients with late-onset Alzheimer's disease. Neurodegener Dis. 2012;10(1-4):207-11. doi: 10.1159/000333799. Epub 2012 Jan 17.
Van der Schueren BJ, Van Laere K, Gerard N, Bormans G, De Hoon JN. Interictal type 1 cannabinoid receptor binding is increased in female migraine patients. Headache. 2012 Mar;52(3):433-40. doi: 10.1111/j.1526-4610.2011.02030.x. Epub 2011 Nov 11.
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.
Frieling H, Albrecht H, Jedtberg S, Gozner A, Lenz B, Wilhelm J, Hillemacher T, de Zwaan M, Kornhuber J, Bleich S. Elevated cannabinoid 1 receptor mRNA is linked to eating disorder related behavior and attitudes in females with eating disorders. Psychoneuroendocrinology. 2009 May;34(4):620-4. doi: 10.1016/j.psyneuen.2008.10.014. Epub 2008 Nov 28.
Greco R, Bandiera T, Mangione AS, Demartini C, Siani F, Nappi G, Sandrini G, Guijarro A, Armirotti A, Piomelli D, Tassorelli C. Effects of peripheral FAAH blockade on NTG-induced hyperalgesia--evaluation of URB937 in an animal model of migraine. Cephalalgia. 2015 Oct;35(12):1065-76. doi: 10.1177/0333102414566862. Epub 2015 Jan 21.
Greco R, Gasperi V, Sandrini G, Bagetta G, Nappi G, Maccarrone M, Tassorelli C. Alterations of the endocannabinoid system in an animal model of migraine: evaluation in cerebral areas of rat. Cephalalgia. 2010 Mar;30(3):296-302. doi: 10.1111/j.1468-2982.2009.01924.x. Epub 2010 Feb 1.
Primary Completion
December 31, 2019
Actual (reported)Study Completion
December 31, 2019
Actual (reported)Last Updated
March 27, 2020
Record last verified: 2020-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: