NCT04361721|UnknownFDA Drug
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Sponsor study identifier
observational
40
1 country
1
Study Start
January 15, 2020
Actual (reported)Primary Completion
June 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Monoclonal antibodies (mABs) targeting calcitonin gene-related peptide (CGRP) proved effective in the preventive treatment of episodic and chronic migraine as well as in difficult-to-treat patients such as those who had previously failed multiple prevention treatments or those with associated medication overuse (MO). A characteristic dysfunction in Chronic Migraine (CM) is sensitization, occurring peripherally in the trigeminovascular system but then spreading to the central nervous system, where it manifests with an increased neuronal excitability in multiple areas. Several neurophysiological studies in CM patients have demonstrated the occurrence of central sensitization in the brain as well as at the spinal level. MicroRNAs (miRNAs) are involved in the generation and maintenance of chronic pain. Current evidence suggests that specific miRNAs may also play a role in migraine, thus representing possible biomarkers of the disease. A previous study reported an upregulation of miR-34a-5p and miR-382-5p, implicated in the regulation of GABAergic signaling and IL-10 gene expression respectively, during migraine attacks. The aim of this open label, hypothesis generating study is the evaluation of the impact of erenumab treatment on neurophysiological, biomolecular and psychological aspects in a representative cohort of CM patients who had previously failed at least 2 preventive treatments.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2021
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.
January 15, 2020
Actual (reported)April 21, 2020
Actual (reported)April 24, 2020
Actual (reported)June 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Spinal sensitization
Measured by the temporal summation threshold (TST) of the nociceptive withdrawal reflex
Change in TST (mA) at T3 (12 weeks later) when compared to baseline (T0)
Spinal sensitization
Change in RTh (mA) at T3 (12 weeks later) when compared to baseline (T0)
Inflammatory biomarker profile
Change in miR-382-5p at T3 (12 weeks later) when compared to baseline (T0)
inflammatory biomarker profile
Change in miR-34a-5p at T3 (12 weeks later) when compared to baseline (T0)
Migraine Disability Assessment (MIDAS)
Change in MIDAS score at T3 (12 weeks later) when compared to baseline (T0)
Headache Impact Test-6 (HIT-6)
Change in HIT-6 score at T3 (12 weeks later) when compared to baseline (T0)
Three monthly administration of erenumab 70 mg subcutaneously.
First injection of erenumab 70 mg subcutaneously was administered in hospital. The second injection of erenumab 70 mg was administered in hospital after 28 days, while the third and last dose of erenumab 70 mg was self-administered at home by the patients themselves after an additional 28-day interval.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Forty patients, affected by CM or CM+MO according to the International Classification of Headache Disorders (ICHD) -3 criteria were enrolled.
IRCCS Mondino Foundation
Pavia, 27100, Italy
Charles A, Pozo-Rosich P. Targeting calcitonin gene-related peptide: a new era in migraine therapy. Lancet. 2019 Nov 9;394(10210):1765-1774. doi: 10.1016/S0140-6736(19)32504-8. Epub 2019 Oct 23.
Ashina M, Tepper S, Brandes JL, Reuter U, Boudreau G, Dolezil D, Cheng S, Zhang F, Lenz R, Klatt J, Mikol DD. Efficacy and safety of erenumab (AMG334) in chronic migraine patients with prior preventive treatment failure: A subgroup analysis of a randomized, double-blind, placebo-controlled study. Cephalalgia. 2018 Sep;38(10):1611-1621. doi: 10.1177/0333102418788347. Epub 2018 Jul 8.
RNA concentration was determined by absorbance at 230 and 280 nm using the NanoDrop Spectrophotometer (Euroclone Milano). Synthesis of cDNA was performed by using MirXMirna First strand Synthesis (Takara-Diatech, Jesi-An Italy) and TB Green q-Rt PCR is used (Takara-Diatech, Jesi-An Italy) to determine expression levels of miRNA-34a-5p and miRNA-382-5p. The denaturation was performed at 95°C and the amplification was performed through two-step cycling (95-60°C) for 40 cycles with a Light Cycler 480 Instrument RT-PCR Detection System (Roche, Milan, Italy). Target gene expression levels was normalized with U6 (a type of small nuclear RNA), used as housekeeping gene. Gene expression levels were calculated according to 2-∆Ct = 2 - (Ct gene - Ct housekeeping gene) formula by using Ct values.
Cristina Tassorelli, MD
IRCCS Mondino Foundation
First Submitted
April 21, 2020
First Posted
April 24, 2020
Study Start
January 15, 2020
Actual (reported)Primary Completion
June 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Novel Insight Into Migraine Pathophysiolgy and Galcanezumab Mechanisms of Action
Contact the study team to confirm eligibility.
Tepper SJ, Diener HC, Ashina M, Brandes JL, Friedman DI, Reuter U, Cheng S, Nilsen J, Leonardi DK, Lenz RA, Mikol DD. Erenumab in chronic migraine with medication overuse: Subgroup analysis of a randomized trial. Neurology. 2019 May 14;92(20):e2309-e2320. doi: 10.1212/WNL.0000000000007497. Epub 2019 Apr 17.
Coppola G, Di Lorenzo C, Schoenen J, Pierelli F. Habituation and sensitization in primary headaches. J Headache Pain. 2013 Jul 30;14(1):65. doi: 10.1186/1129-2377-14-65.
De Icco R, Perrotta A, Grillo V, Cosentino G, Sances G, Sandrini G, Tassorelli C. Experimentally induced spinal nociceptive sensitization increases with migraine frequency: a single-blind controlled study. Pain. 2020 Feb;161(2):429-438. doi: 10.1097/j.pain.0000000000001726.
Andersen HH, Duroux M, Gazerani P. Serum MicroRNA Signatures in Migraineurs During Attacks and in Pain-Free Periods. Mol Neurobiol. 2016 Apr;53(3):1494-1500. doi: 10.1007/s12035-015-9106-5. Epub 2015 Feb 1.
Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. doi: 10.1177/0333102417738202. No abstract available.
Demartini C, Greco R, Zanaboni AM, Sances G, De Icco R, Borsook D, Tassorelli C. Nitroglycerin as a comparative experimental model of migraine pain: From animal to human and back. Prog Neurobiol. 2019 Jun;177:15-32. doi: 10.1016/j.pneurobio.2019.02.002. Epub 2019 Feb 13.
Sandrini G, Serrao M, Rossi P, Romaniello A, Cruccu G, Willer JC. The lower limb flexion reflex in humans. Prog Neurobiol. 2005 Dec;77(6):353-95. doi: 10.1016/j.pneurobio.2005.11.003. Epub 2005 Dec 28.
Schmittgen TD, Livak KJ. Analyzing real-time PCR data by the comparative C(T) method. Nat Protoc. 2008;3(6):1101-8. doi: 10.1038/nprot.2008.73.
Stewart WF, Lipton RB, Dowson AJ, Sawyer J. Development and testing of the Migraine Disability Assessment (MIDAS) Questionnaire to assess headache-related disability. Neurology. 2001;56(6 Suppl 1):S20-8. doi: 10.1212/wnl.56.suppl_1.s20.
Kosinski M, Bayliss MS, Bjorner JB, Ware JE Jr, Garber WH, Batenhorst A, Cady R, Dahlof CG, Dowson A, Tepper S. A six-item short-form survey for measuring headache impact: the HIT-6. Qual Life Res. 2003 Dec;12(8):963-74. doi: 10.1023/a:1026119331193.
Lipton RB, Bigal ME, Ashina S, Burstein R, Silberstein S, Reed ML, Serrano D, Stewart WF; American Migraine Prevalence Prevention Advisory Group. Cutaneous allodynia in the migraine population. Ann Neurol. 2008 Feb;63(2):148-58. doi: 10.1002/ana.21211.
Jhingran P, Osterhaus JT, Miller DW, Lee JT, Kirchdoerfer L. Development and validation of the Migraine-Specific Quality of Life Questionnaire. Headache. 1998 Apr;38(4):295-302. doi: 10.1046/j.1526-4610.1998.3804295.x.
Apolone G, Mosconi P. The Italian SF-36 Health Survey: translation, validation and norming. J Clin Epidemiol. 1998 Nov;51(11):1025-36. doi: 10.1016/s0895-4356(98)00094-8.
Scalone L, Cortesi PA, Mantovani LG, Ciampichini R, Cesana G. Reference Eq-5d-3l and Eq-5d-5l Data From the Italian General Population. Value Health. 2014 Nov;17(7):A514-5. doi: 10.1016/j.jval.2014.08.1591. Epub 2014 Oct 26. No abstract available.
Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res. 2002 Feb;52(2):69-77. doi: 10.1016/s0022-3999(01)00296-3.
Raistrick D, Bradshaw J, Tober G, Weiner J, Allison J, Healey C. Development of the Leeds Dependence Questionnaire (LDQ): a questionnaire to measure alcohol and opiate dependence in the context of a treatment evaluation package. Addiction. 1994 May;89(5):563-72. doi: 10.1111/j.1360-0443.1994.tb03332.x.
Bagby RM, Parker JDA, Taylor GJ. Twenty-five years with the 20-item Toronto Alexithymia Scale. J Psychosom Res. 2020 Apr;131:109940. doi: 10.1016/j.jpsychores.2020.109940. Epub 2020 Jan 23.
Bottiroli S, Galli F, Viana M, Sances G, Tassorelli C. Traumatic Experiences, Stressful Events, and Alexithymia in Chronic Migraine With Medication Overuse. Front Psychol. 2018 May 14;9:704. doi: 10.3389/fpsyg.2018.00704. eCollection 2018.
Bottiroli S, De Icco R, Vaghi G, Pazzi S, Guaschino E, Allena M, Ghiotto N, Martinelli D, Tassorelli C, Sances G. Psychological predictors of negative treatment outcome with Erenumab in chronic migraine: data from an open label long-term prospective study. J Headache Pain. 2021 Oct 2;22(1):114. doi: 10.1186/s10194-021-01333-4.
De Icco R, Fiamingo G, Greco R, Bottiroli S, Demartini C, Zanaboni AM, Allena M, Guaschino E, Martinelli D, Putorti A, Grillo V, Sances G, Tassorelli C. Neurophysiological and biomolecular effects of erenumab in chronic migraine: An open label study. Cephalalgia. 2020 Oct;40(12):1336-1345. doi: 10.1177/0333102420942230. Epub 2020 Jul 26.
Study Completion
June 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 19, 2021
Record last verified: 2020-04
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