Anti-CGRP Monoclonal Antibody Response After Switching (AMARAS)

NCT05785988 | Recruiting

• 1 other identifier: PI-22-2658
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

Monoclonal antibodies targeting calcitonin gene-related peptide (mAb-CGRP) have shown efficacy and effectiveness in the treatment of episodic and chronic migraine, however, not all patients respond to them. Preliminary data suggests that some patients who failed to one of them, may respond to a different anti-CGRP monoclonal antibody. Observational analytic study with a retrospective cohort design including patients treated with a second mAb-CGRP due to lack of response to the first one. The aim of this study is to provide Class II evidence about the effectiveness and tolerability of the mAb-CGRP switching in patients with migraine, treated in a real-world setting.

Conditions

Migraine; Head Pain

Keywords

Headache disorders; Painful disorders; Calcitonin gene-related peptide (CGRP)

Outcome Measures

Primary Outcomes (1)

• 50% response weeks 8-12

  To evaluate the proportion of patients with migraine treated with a second anti-CGRP monoclonal antibody that achieve a 50% response

  Between weeks 8-12 of treatment, compared to the month prior to the start of treatment

Secondary Outcomes (30)

• 50% response weeks 20-24

  Between weeks 20-24 of treatment, compared to the month prior to the start of treatment

• 50% response weeks 32-36

  Between weeks 32-36 of treatment, compared to the month prior to the start of treatment

• 50% response weeks 44-48

  Between weeks 44-48 of treatment, compared to the month prior to the start of treatment

• 30% response weeks 8-12

  Between weeks 8-12 of treatment, compared to the month prior to the start of treatment

• 30% response weeks 20-24

  Between weeks 20-24 of treatment, compared to the month prior to the start of treatment

Study Arms (1)

Patients with migraine treated with a second anti-CGRP

Patients with migraine treated with a second anti-CGRP monoclonal antibody as per responsible physician criteria in routine clinical practice.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients treated with mAb-CGRP in the participating sites are screened for eligibility, including the administrative databases of all patients treated during the study period.

You may qualify if:

• \. Age over 18 years old;
• \. Confirmed diagnosis of migraine, according to the International Classification of Headche Disorders, 3rd version;
• \. Treatment with a mAb-CGRP as per responsible physician criteria in routine clinical practice.

You may not qualify if:

• \. Unavailability of information prior to the treatment use;
• \. Other painful disorders that may interfere in the evaluation of the outcomes.

Sponsors & Collaborators

• Hospital Clínico Universitario de Valladolid: lead
• Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León: collaborator

Study Sites (1)

Hospital Clínico Universitario de Valladolid

Valladolid, 47010, Spain

RECRUITING

Related Publications (12)

• Steiner TJ, Stovner LJ, Jensen R, Uluduz D, Katsarava Z; Lifting The Burden: the Global Campaign against Headache. Migraine remains second among the world's causes of disability, and first among young women: findings from GBD2019. J Headache Pain. 2020 Dec 2;21(1):137. doi: 10.1186/s10194-020-01208-0. No abstract available.

  PMID: 33267788 BACKGROUND

• Deuschl G, Beghi E, Fazekas F, Varga T, Christoforidi KA, Sipido E, Bassetti CL, Vos T, Feigin VL. The burden of neurological diseases in Europe: an analysis for the Global Burden of Disease Study 2017. Lancet Public Health. 2020 Oct;5(10):e551-e567. doi: 10.1016/S2468-2667(20)30190-0.

  PMID: 33007212 BACKGROUND

• GBD 2016 Neurology Collaborators. Global, regional, and national burden of neurological disorders, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 May;18(5):459-480. doi: 10.1016/S1474-4422(18)30499-X. Epub 2019 Mar 14.

  PMID: 30879893 BACKGROUND

• Charles A. The pathophysiology of migraine: implications for clinical management. Lancet Neurol. 2018 Feb;17(2):174-182. doi: 10.1016/S1474-4422(17)30435-0. Epub 2017 Dec 8.

  PMID: 29229375 BACKGROUND

• Ashina M, Terwindt GM, Al-Karagholi MA, de Boer I, Lee MJ, Hay DL, Schulte LH, Hadjikhani N, Sinclair AJ, Ashina H, Schwedt TJ, Goadsby PJ. Migraine: disease characterisation, biomarkers, and precision medicine. Lancet. 2021 Apr 17;397(10283):1496-1504. doi: 10.1016/S0140-6736(20)32162-0. Epub 2021 Mar 25.

  PMID: 33773610 BACKGROUND

• 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.

  PMID: 31668411 BACKGROUND

• Drellia K, Kokoti L, Deligianni CI, Papadopoulos D, Mitsikostas DD. Anti-CGRP monoclonal antibodies for migraine prevention: A systematic review and likelihood to help or harm analysis. Cephalalgia. 2021 Jun;41(7):851-864. doi: 10.1177/0333102421989601. Epub 2021 Feb 10.

  PMID: 33567891 BACKGROUND

• Gantenbein AR, Agosti R, Gobbi C, Flugel D, Schankin CJ, Viceic D, Zecca C, Pohl H. Impact on monthly migraine days of discontinuing anti-CGRP antibodies after one year of treatment - a real-life cohort study. Cephalalgia. 2021 Oct;41(11-12):1181-1186. doi: 10.1177/03331024211014616. Epub 2021 May 17.

  PMID: 34000847 BACKGROUND

• Vernieri F, Altamura C, Brunelli N, Costa CM, Aurilia C, Egeo G, Fofi L, Favoni V, Pierangeli G, Lovati C, Aguggia M, d'Onofrio F, Doretti A, Di Fiore P, Finocchi C, Rao R, Bono F, Ranieri A, Albanese M, Cevoli S, Barbanti P; GARLIT Study Group. Galcanezumab for the prevention of high frequency episodic and chronic migraine in real life in Italy: a multicenter prospective cohort study (the GARLIT study). J Headache Pain. 2021 May 3;22(1):35. doi: 10.1186/s10194-021-01247-1.

  PMID: 33941080 BACKGROUND

• Overeem LH, Peikert A, Hofacker MD, Kamm K, Ruscheweyh R, Gendolla A, Raffaelli B, Reuter U, Neeb L. Effect of antibody switch in non-responders to a CGRP receptor antibody treatment in migraine: A multi-center retrospective cohort study. Cephalalgia. 2022 Apr;42(4-5):291-301. doi: 10.1177/03331024211048765. Epub 2021 Oct 13.

  PMID: 34644203 BACKGROUND

• Porta-Etessam J, Gonzalez-Garcia N, Guerrero AL, Garcia-Azorin D. Failure to monoclonal antibodies against CGRP or its receptor does not preclude lack of efficacy to other drugs from the same therapeutic class. Neurologia (Engl Ed). 2020 Nov 8:S0213-4853(20)30312-1. doi: 10.1016/j.nrl.2020.10.009. Online ahead of print. No abstract available. English, Spanish.

  PMID: 33176918 BACKGROUND

• Ferreira JA. The Benjamini-Hochberg method in the case of discrete test statistics. Int J Biostat. 2007;3(1):Article 11. doi: 10.2202/1557-4679.1065.

  PMID: 22550651 BACKGROUND

MeSH Terms

Conditions

Migraine Disorders; Headache; Headache Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David García Azorín, MD, PhD

  Research coordinator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David García-Azorín, MD, MSci

CONTACT

+034 665 872228; davilink@hotmail.com

Yesica Gonzalez Osorio

CONTACT

+34 634330426; ygoinvestigacion@outlook.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Headache Unit, Department of Neurology, Principal Investigator

Study Record Dates

• First Submitted: March 11, 2023
• First Posted: March 27, 2023
• Study Start: November 1, 2019
• Primary Completion: November 10, 2024
• Study Completion: November 10, 2024
• Last Updated: February 14, 2024

Record last verified: 2024-02

Locations

ES (1)