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NCT04361721

Neurophysiological, Biomolecular and Psychological Aspects of Erenumab Treatment in Chronic Migraine

Status unknown Last updated 19 April 2021
What this trial tests

trial testing Erenumab in Chronic Migraine in 40 participants. Status unknown.

Timeline
15 January 2020
Primary endpoint
30 June 2021
30 June 2021

Quick facts

Lead sponsorIRCCS National Neurological Institute "C. Mondino" Foundation
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment40
Start date15 January 2020
Primary completion30 June 2021
Estimated completion30 June 2021
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

Sponsor

IRCCS National Neurological Institute "C. Mondino" Foundation

Who can join

Adults 18 to 65, any sex, with Chronic Migraine. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Psychological predictors of negative treatment outcome with Erenumab in chronic migraine: data from an open label long-term prospective study.
    Bottiroli S, De Icco R, Vaghi G, Pazzi S, et al · · 2021 · cited 42× · PMID 34600468 · DOI 10.1186/s10194-021-01333-4
  2. Neurophysiological and biomolecular effects of erenumab in chronic migraine: An open label study.
    De Icco R, Fiamingo G, Greco R, Bottiroli S, et al · · 2020 · cited 21× · PMID 32715736 · DOI 10.1177/0333102420942230
  3. Migraine Prevention with Erenumab: Focus on Patient Selection, Perspectives and Outcomes.
    De Matteis E, Sacco S, Ornello R. · · 2022 · cited 5× · PMID 35411146 · DOI 10.2147/tcrm.s263825
  4. Psychological Predictors of Negative Treatment Outcome with Erenumab in Chronic Migraine: Data From an Open Label Long-Term Prospective Study
    Bottiroli S, De Icco R, Vaghi G, Pazzi S, et al · · 2021 · DOI 10.21203/rs.3.rs-786742/v1

Verify or expand the search:

Other trials of Erenumab

Trials testing the same drug.

Other recruiting trials for Chronic Migraine

Currently open trials in the same condition.

Other IRCCS National Neurological Institute "C. Mondino" Foundation trials

Trials by the same sponsor.

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