Monoclonal Antibody Duration of REsponse in MIgraine After Treatment Interruption

NCT05232942 | Recruiting

• 1 other identifier: PI 20-1687
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Observational analytic study with a prospective cohort design. Patients with episodic and chronic migraine that have responded to monoclonal antibodies (mAbs) versus calcitonin gene-related peptide (CGRP) or its receptor with positive response will be included. A headache diary will be completed in a daily basis. The primary outcome will be the time elapsed between the discontinuation of the monoclonal antibody and the return to the clinical situation at the moment of the mAbs onset. The potential variables that may be associated with a more sustained benefit will be explored.

Conditions

Migraine; Headache, Migraine

Keywords

Treatment outcome; Evidence-based practice; Headache disorders, primary; Migraine; Treatment; Preventive treatment

Outcome Measures

Primary Outcomes (1)

• Return to the baseline

  The needed number of months elapsed until the patient has a number of headache days per month that equals the situation at the moment of the monoclonal antibody onset, or the need of other prophylactic medication.

  Through study completion, an average of 3 months

Secondary Outcomes (5)

• Worsening within the first three months

  Through study completion, an average of 3 months

• Worsening between three and six months

  Through study completion, an average of 6 months

• Worsening between six and nine months

  Through study completion, an average of 9 months

• Worsening between nine and twelve months

  Through study completion, an average of 12 months

• Explore predictors of a more prolonged response

  Through study completion, an average of 12 months

Study Arms (1)

Studied group

The study population will consist of patients with diagnosis of episodic or chronic migraine who, under the criteria of their neurologist and according to the clinical practice guidelines and standard of care, receive treatment with monoclonal antibodies against CGRP (galcanezumab, fremanezumab or eptinezumab) or else its receptor (erenumab), with positive response, and discontinue the treatment.

Other: Headache calendar completion

Interventions

Headache calendar completion OTHER

The patient will complete an in-paper or electronic calendar, depicting the presence/absence of headache, the median intensity and the need of acute medication.

Studied group

Eligibility Criteria

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

Study Population

Patients with diagnosis of episodic or chronic migraine who, under the criteria of their neurologist and according to the clinical practice guidelines and standard of care, receive treatment with monoclonal antibodies against CGRP (galcanezumab, fremanezumab or eptinezumab) or else its receptor (erenumab) will be included

You may qualify if:

• Patients diagnosed with episodic or chronic migraine according to criteria of the International Classification of Headache Disorders, 3rd Edition.
• Patients who previously received treatment with a monoclonal antibody (mABs) against CGRP or its receptor at the discretion of their usual neurologist, according to the standard of care and local guidelines.
• Patients who experienced a positive therapeutic response to mAbs.
• Patients that received the treatment for a minimum of 3 months.
• Age between 18 and 65 years.
• Participants must be capable to describe his/her clinical situation and the characteristics of his/her headache.
• Participants must have signed the informed consent and have sufficient understanding of Spanish language.

You may not qualify if:

• Presence of another type of concomitant chronic headache, defined by frequency greater than 15 days per month in the previous three months, except for medication overuse headache.
• Pregnancy or breastfeeding.
• Patients who discontinued treatment with the monoclonal antibody due to an adverse effect and not to an efficacy response.

Sponsors & Collaborators

• Hospital Clínico Universitario de Valladolid: lead

Study Sites (1)

Hospital Clínico Universitario de Valladolid

Valladolid, 47010, Spain

RECRUITING

Related Publications (20)

• Deen M, Correnti E, Kamm K, Kelderman T, Papetti L, Rubio-Beltran E, Vigneri S, Edvinsson L, Maassen Van Den Brink A; European Headache Federation School of Advanced Studies (EHF-SAS). Blocking CGRP in migraine patients - a review of pros and cons. J Headache Pain. 2017 Sep 25;18(1):96. doi: 10.1186/s10194-017-0807-1.

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• Edvinsson L, Haanes KA, Warfvinge K, Krause DN. CGRP as the target of new migraine therapies - successful translation from bench to clinic. Nat Rev Neurol. 2018 Jun;14(6):338-350. doi: 10.1038/s41582-018-0003-1.

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• Tepper S, Ashina M, Reuter U, Brandes JL, Dolezil D, Silberstein S, Winner P, Leonardi D, Mikol D, Lenz R. Safety and efficacy of erenumab for preventive treatment of chronic migraine: a randomised, double-blind, placebo-controlled phase 2 trial. Lancet Neurol. 2017 Jun;16(6):425-434. doi: 10.1016/S1474-4422(17)30083-2. Epub 2017 Apr 28.

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• Goadsby PJ, Reuter U, Hallstrom Y, Broessner G, Bonner JH, Zhang F, Sapra S, Picard H, Mikol DD, Lenz RA. A Controlled Trial of Erenumab for Episodic Migraine. N Engl J Med. 2017 Nov 30;377(22):2123-2132. doi: 10.1056/NEJMoa1705848.

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• Silberstein SD, Dodick DW, Bigal ME, Yeung PP, Goadsby PJ, Blankenbiller T, Grozinski-Wolff M, Yang R, Ma Y, Aycardi E. Fremanezumab for the Preventive Treatment of Chronic Migraine. N Engl J Med. 2017 Nov 30;377(22):2113-2122. doi: 10.1056/NEJMoa1709038.

  PMID: 29171818 BACKGROUND

• Stauffer VL, Dodick DW, Zhang Q, Carter JN, Ailani J, Conley RR. Evaluation of Galcanezumab for the Prevention of Episodic Migraine: The EVOLVE-1 Randomized Clinical Trial. JAMA Neurol. 2018 Sep 1;75(9):1080-1088. doi: 10.1001/jamaneurol.2018.1212.

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• Skljarevski V, Matharu M, Millen BA, Ossipov MH, Kim BK, Yang JY. Efficacy and safety of galcanezumab for the prevention of episodic migraine: Results of the EVOLVE-2 Phase 3 randomized controlled clinical trial. Cephalalgia. 2018 Jul;38(8):1442-1454. doi: 10.1177/0333102418779543. Epub 2018 May 31.

  PMID: 29848108 BACKGROUND

• Detke HC, Goadsby PJ, Wang S, Friedman DI, Selzler KJ, Aurora SK. Galcanezumab in chronic migraine: The randomized, double-blind, placebo-controlled REGAIN study. Neurology. 2018 Dec 11;91(24):e2211-e2221. doi: 10.1212/WNL.0000000000006640. Epub 2018 Nov 16.

  PMID: 30446596 BACKGROUND

• Dodick DW, Ashina M, Brandes JL, Kudrow D, Lanteri-Minet M, Osipova V, Palmer K, Picard H, Mikol DD, Lenz RA. ARISE: A Phase 3 randomized trial of erenumab for episodic migraine. Cephalalgia. 2018 May;38(6):1026-1037. doi: 10.1177/0333102418759786. Epub 2018 Feb 22.

  PMID: 29471679 BACKGROUND

• Dodick DW, Silberstein SD, Bigal ME, Yeung PP, Goadsby PJ, Blankenbiller T, Grozinski-Wolff M, Yang R, Ma Y, Aycardi E. Effect of Fremanezumab Compared With Placebo for Prevention of Episodic Migraine: A Randomized Clinical Trial. JAMA. 2018 May 15;319(19):1999-2008. doi: 10.1001/jama.2018.4853.

  PMID: 29800211 BACKGROUND

• Ferrari MD, Diener HC, Ning X, Galic M, Cohen JM, Yang R, Mueller M, Ahn AH, Schwartz YC, Grozinski-Wolff M, Janka L, Ashina M. Fremanezumab versus placebo for migraine prevention in patients with documented failure to up to four migraine preventive medication classes (FOCUS): a randomised, double-blind, placebo-controlled, phase 3b trial. Lancet. 2019 Sep 21;394(10203):1030-1040. doi: 10.1016/S0140-6736(19)31946-4. Epub 2019 Aug 16.

  PMID: 31427046 BACKGROUND

• Aurora SK, Winner P, Freeman MC, Spierings EL, Heiring JO, DeGryse RE, VanDenburgh AM, Nolan ME, Turkel CC. OnabotulinumtoxinA for treatment of chronic migraine: pooled analyses of the 56-week PREEMPT clinical program. Headache. 2011 Oct;51(9):1358-73. doi: 10.1111/j.1526-4610.2011.01990.x. Epub 2011 Aug 29.

  PMID: 21883197 BACKGROUND

• Diener HC, Bussone G, Van Oene JC, Lahaye M, Schwalen S, Goadsby PJ; TOPMAT-MIG-201(TOP-CHROME) Study Group. Topiramate reduces headache days in chronic migraine: a randomized, double-blind, placebo-controlled study. Cephalalgia. 2007 Jul;27(7):814-23. doi: 10.1111/j.1468-2982.2007.01326.x. Epub 2007 Apr 18.

  PMID: 17441971 BACKGROUND

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  PMID: 31498897 BACKGROUND

• Raffaelli B, Mussetto V, Israel H, Neeb L, Reuter U. Erenumab and galcanezumab in chronic migraine prevention: effects after treatment termination. J Headache Pain. 2019 Jun 3;20(1):66. doi: 10.1186/s10194-019-1018-8.

  PMID: 31159727 BACKGROUND

• Dominguez C, Pozo-Rosich P, Torres-Ferrus M, Hernandez-Beltran N, Jurado-Cobo C, Gonzalez-Oria C, Santos S, Monzon MJ, Latorre G, Alvaro LC, Gago A, Gallego M, Medrano V, Huerta M, Garcia-Alhama J, Belvis R, Leira Y, Leira R. OnabotulinumtoxinA in chronic migraine: predictors of response. A prospective multicentre descriptive study. Eur J Neurol. 2018 Feb;25(2):411-416. doi: 10.1111/ene.13523. Epub 2017 Dec 18.

  PMID: 29171146 BACKGROUND

• Pagola I, Esteve-Belloch P, Palma JA, Luquin MR, Riverol M, Martinez-Vila E, Irimia P. [Predictive factors of the response to treatment with onabotulinumtoxinA in refractory migraine]. Rev Neurol. 2014 Mar 16;58(6):241-6. Spanish.

  PMID: 24610690 BACKGROUND

MeSH Terms

Conditions

Migraine Disorders; Headache Disorders, Primary

Condition Hierarchy (Ancestors)

Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• David García Azorín, MD, PhD

  Research coordinator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Garcia Azorin, MD, PhD

CONTACT

+34 665872228; davilink@hotmail.com

Yésica Gonzalez Osorio

CONTACT

+34 685429760; ygoinvestigacion@outlook.com

Study Design

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

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: February 10, 2022
• Study Start: February 15, 2022
• Primary Completion: February 15, 2024
• Study Completion: August 15, 2024
• Last Updated: April 29, 2024

Record last verified: 2024-04

Locations

ES (1)