MigraineAMARASNCT05785988
Anti-CGRP Monoclonal Antibody Response After Switching (AMARAS)
An observational study of Migraine and Head Pain, run by Hospital Clínico Universitario de Valladolid at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 600 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2019to 10 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 1. Age over 18 years old;
- 2. Confirmed diagnosis of migraine, according to the International Classification of Headche Disorders, 3rd version;
- 3. Treatment with a mAb-CGRP as per responsible physician criteria in routine clinical practice.
Who cannot join
- 1. Unavailability of information prior to the treatment use;
- 2. Other painful disorders that may interfere in the evaluation of the outcomes.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clínico Universitario de Valladolid
Valladolid, 47010
David Garcia Azorin, MD, PhD
About this study
Official title: Anti-Calcitonin Gene-Related Peptide (CGRP) Monoclonal Antibody Response After Switching in the Treatment of Migraine
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.
Read the detailed description
Background:
Migraine is the first cause of disability in the most active ages of life. Unlike other diseases, there are effective treatments that can lessen the burden of the disease. Currently, there are different treatments that act at different levels, many of them being non-migraine-specific and associated to poor tolerability. The monoclonal antibodies targeting calcitonin gene-related peptide (mAb-CGRP), or its receptor have shown efficacy in the treatment of episodic and chronic migraine, with a significantly lower rate of side effects. In Spain, the National Health System subsidizes them in patients with high-frequency episodic migraine or chronic migraine with prior failure to at least three preventive drugs.
There is preliminary evidence that suggest that approximately one-third of patients who have not responded to one mAb-CGRP may respond to a different mAb-CGRP, not necessarily with a different mechanism of action. 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.
Study design:
Observational analytic study with a retrospective cohort design.
Endpoints:
The study endpoints will be based on the International Headache Society guidelines for controlled trials of chronic migraine, and will include effectiveness endpoints and safety endpoints.
Sample Size:
According to real-world data in our setting, the effectiveness rate of monoclonal antibodies in clinical practice conditions ranges between 40-60%. We aim to collect at least 300 patients treated with a secondary mAb-CGRP.
Methodology:
Observational analytic study with a retrospective cohort design. Spanish Hospitals with Headache Units or monographic headache consultations participate in the study. In all participant centers, patients carried out a headache diary that assesses the frequency of headache, migraine and acute treatment use.
Study intervention:
A structured questionnaire will be administered to patients, including demographic variables, such as sex, age at migraine onset, age at first mAb-CGRP use, age at second mAb-CGRP use. The following clinical variables were collected type of migraine (episodic / chronic), duration (in months) of high-frequency episodic migraine or chronic migraine; presence and type of aura; number and type of prior prophylactic drugs; mAb-CGRP used in first and second place; reason for discontinuation (lack of efficacy, lack of tolerability); frequency of headache, migraine, acute medication and triptan use per month; presence and type of adverse effects.
All the information was introduced in a standardize data collection form that will be hosted in RedCap.
Recruitment and sampling:
All consecutive patients treated with mAb-CGRP in the participating sites were screened for eligibility, including the administrative databases of all patients treated during the study period.
Data sources:
Paper or electronic health records was used, and structured headache diaries were provided to patients.
Ethics:
The study has been approved by the Ethics Review Board of East Valladolid (PI-22-2658). The study is conducted in accordance with the principles of the Declaration of Helsinki
Statistical Analysis:
First, a descriptive analysis will be carried out. The proportion of patients treated with a monoclonal antibody who receive treatment with a second will be described. A sub-group analysis will be done, depending on whether the reason for the mAb-CGRP switch an effectiveness failure or a tolerability failure was. The 50%, 30%, and 75% response rates will be calculated in the pre-specified study periods, as well as the frequency and type of adverse effects. To evaluate the reduction in days of headache per month, days of migraine, days of use of analgesics, and days of triptans, in the study periods, in relation to the baseline period, the Student's T-test for paired samples will be used. or the Mann-Whitney U, depending on the type of distribution of the sample. Normality of the sample will be assessed with the Kolmogorov-Smirnov test. To evaluate the predictors of response, a logistic regression analysis will be performed in which the independent variable will be the presence of a 50% response between weeks 8-12, and the rest of the study variables will be evaluated first by univariate regression, and after that, analysis multivariate in those with a P value less than 0.1.
Statistical analysis will be performed both by intention to treat (including all patients receiving treatment with a second monoclonal) and per-protocol analysis (those in which the information is complete). In case of missing data, for variables related to treatment, a conservative imputation will be performed using baseline-carried forward, for variables from 8-12 weeks and last-observation carried forward for variables from weeks 8-12.
A stratified analysis will be performed according to whether the reason for discontinuation of the first monoclonal antibody was the failure of effectiveness or lack of tolerance. A stratified analysis will also be performed in treatments between drugs directed against CGRP and their receptor A statistical significance level of 5% will be considered. The correction will be made for multiple comparisons by False Discovery Rate, using the Benjamini-Hochberg method.
- Keywords
- Headache disorders, Painful disorders, Calcitonin gene-related peptide (CGRP)
- Medical subject headings
- Migraine Disorders, Headache, Headache Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Between weeks 8-12 of treatment, compared to the month prior to the start of treatment
Secondary outcomes (30)
50% response weeks 20-24
To evaluate the proportion of patients with migraine treated with a second anti-CGRP monoclonal antibody that achieve a 50% response
Measured: Between weeks 20-24 of treatment, compared to the month prior to the start of treatment
50% response weeks 32-36
To evaluate the proportion of patients with migraine treated with a second anti-CGRP monoclonal antibody that achieve a 50% response
Measured: Between weeks 32-36 of treatment, compared to the month prior to the start of treatment
50% response weeks 44-48
To evaluate the proportion of patients with migraine treated with a second anti-CGRP monoclonal antibody that achieve a 50% response
Measured: Between weeks 44-48 of treatment, compared to the month prior to the start of treatment
30% response weeks 8-12
To evaluate the proportion of patients with migraine treated with a second anti-CGRP monoclonal antibody that achieve a 30% response
Measured: Between weeks 8-12 of treatment, compared to the month prior to the start of treatment
30% response weeks 20-24
To evaluate the proportion of patients with migraine treated with a second anti-CGRP monoclonal antibody that achieve a 30% response
Measured: Between weeks 20-24 of treatment, compared to the month prior to the start of treatment
30% response weeks 32-36
To evaluate the proportion of patients with migraine treated with a second anti-CGRP monoclonal antibody that achieve a 30% response
Measured: Between weeks 32-36 of treatment, compared to the month prior to the start of treatment
30% response weeks 44-48
To evaluate the proportion of patients with migraine treated with a second anti-CGRP monoclonal antibody that achieve a 30% response
Measured: Between weeks 44-48 of treatment, compared to the month prior to the start of treatment
75% response weeks 8-12
To evaluate the proportion of patients with migraine treated with a second anti-CGRP monoclonal antibody that achieve a 75% response
Measured: Between weeks 8-12 of treatment, compared to the month prior to the start of treatment
75% response weeks 20-24
To evaluate the proportion of patients with migraine treated with a second anti-CGRP monoclonal antibody that achieve a 75% response
Measured: Between weeks 20-24 of treatment, compared to the month prior to the start of treatment
75% response weeks 32-36
Evaluate the proportion of patients with migraine treated with a second anti-CGRP monoclonal antibody that achieve a 75% response
Measured: Between weeks 32-36 of treatment, compared to the month prior to the start of treatment
75% response weeks 44-48
To evaluate the proportion of patients with migraine treated with a second anti-CGRP monoclonal antibody that achieve a 75% response
Measured: Between weeks 44-48 of treatment, compared to the month prior to the start of treatment
Change in headache days per month weeks 8-12
To evaluate the change in headache days per month
Measured: Between weeks 8-12 compared to the month prior to starting treatment
Change in migraine days per month weeks 8-12
To evaluate the change in migraine days per month
Measured: Between weeks 8-12 compared to the month prior to starting treatment
Change in days of use of symptomatic medication per month weeks 8-12
To evaluate the change in days of use of symptomatic medication per month
Measured: Between weeks 8-12 with respect to the month prior to the start of treatment
Change in days of use of triptan per month weeks 8-12
To evaluate the change in days of triptan use per month
Measured: Between weeks 8-12 with respect to the month prior to the start of treatment
Change in headache days per month weeks 20-24
To evaluate the change in headache days per month
Measured: Between weeks 20-24 compared to the month prior to starting treatment
Change in migraine days per month weeks 20-24
To evaluate the change in migraine days per month
Measured: Between weeks 20-24 compared to the month prior to starting treatment
Change in days of use of symptomatic medication per month weeks 20-24
To evaluate the change in days of use of symptomatic medication per month
Measured: Between weeks 20-24 with respect to the month prior to the start of treatment
Change in days of use of triptan per month weeks 20-24
To evaluate the change in days of use of triptans per month
Measured: Between weeks 20-24 with respect to the month prior to the start of treatment
Change in headache days per month weeks 32-36
To evaluate the change in headache days per month
Measured: Between weeks 32-36 compared to the month prior to starting treatment
Change in migraine days per month weeks 32-36
To evaluate the change in migraine days per month
Measured: Between weeks 32-36 compared to the month prior to starting treatment
Change in days of use of symptomatic medication per month weeks 32-36
To evaluate the change in days of use of symptomatic medication per month
Measured: Between weeks 32-36 with respect to the month prior to the start of treatment
Change in days of use of triptan per month weeks 32-36
To evaluate the change in days of triptan use per month
Measured: Between weeks 32-36 compared to the month prior to the start of treatment
Change in headache days per month weeks 44-48
To evaluate the change in headache days per month
Measured: Between weeks 44-48 compared to the month prior to starting treatment
Change in migraine days per month weeks 44-48
To evaluate the change in migraine days per month
Measured: Between weeks 44-48 compared to the month prior to starting treatment
Change in days of use of symptomatic medication per month weeks 44-48
To evaluate the change in days of use of symptomatic medication per month
Measured: Between weeks 44-48 with respect to the month prior to the start of treatment
Change in days of use of triptan per month weeks 44-48
To evaluate the change in days of triptan use per month
Measured: Between weeks 44-48 compared to the month prior to starting treatment
Frequency and type of adverse events
To assess the frequency and type of treatment-related adverse events
Measured: Through study completion, an average of 1 year
Adverse events leading to treatment discontinuation
To evaluate the proportion of patients who discontinue treatment due to an adverse effect
Measured: Through study completion, an average of 1 year
Predictors of 50% response
To explore possible predictors of response, using as a response variable the presence of a 50% response
Measured: Between weeks 8-12, in relation to the month prior to the start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start1 Nov 2019
- Primary completion10 Nov 2024 (estimated)
- Study completion10 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clínico Universitario de Valladolid
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
- Responsible party
- Principal investigator, David García Azorín, Hospital Clínico Universitario de Valladolid
- Investigators
- David García Azorín, MD, PhD, Principal investigator, Research coordinator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05785988
- Sponsor's protocol ID
- PI-22-2658
- Acronym
- AMARAS
- Status last verified
- Feb 2024
- First submitted
- 11 Mar 2023
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anonymized data may be shared upon reasonable request to the principal investigator.
Publications
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.
PubMed 33267788Deuschl 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.
PubMed 33007212GBD 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.
PubMed 30879893Charles 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.
PubMed 29229375Ashina 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.
PubMed 33773610Charles 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.
PubMed 31668411Drellia 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.
PubMed 33567891Gantenbein 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.
PubMed 34000847Vernieri 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.
PubMed 33941080Overeem 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.
PubMed 34644203Porta-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.
PubMed 33176918Ferreira 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.
PubMed 22550651
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-Calcitonin Gene-Related Peptide (CGRP) Monoclonal Antibody Response After Switching in the Treatment of Migraine
- ClinicalTrials.gov ID
- NCT05785988
- Acronym / sponsor ID
- AMARAS / PI-22-2658
- Keywords
- Headache disorders, Painful disorders, Calcitonin gene-related peptide (CGRP)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Hospital Clínico Universitario de ValladolidUniversity, hospital or other
- Collaborators
- Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 10 Nov 2024 (estimated)
- Study completion
- 10 Nov 2024 (estimated)
- First posted
- 27 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
Migraine is the first cause of disability in the most active ages of life. Unlike other diseases, there are effective treatments that can lessen the burden of the disease. Currently, there are different treatments that act at different levels, many of them being non-migraine-specific and associated to poor tolerability. The monoclonal antibodies targeting calcitonin gene-related peptide (mAb-CGRP), or its receptor have shown efficacy in the treatment of episodic and chronic migraine, with a significantly lower rate of side effects. In Spain, the National Health System subsidizes them in patients with high-frequency episodic migraine or chronic migraine with prior failure to at least three preventive drugs.
There is preliminary evidence that suggest that approximately one-third of patients who have not responded to one mAb-CGRP may respond to a different mAb-CGRP, not necessarily with a different mechanism of action. 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.
Study design:
Observational analytic study with a retrospective cohort design.
Endpoints:
The study endpoints will be based on the International Headache Society guidelines for controlled trials of chronic migraine, and will include effectiveness endpoints and safety endpoints.
Sample Size:
According to real-world data in our setting, the effectiveness rate of monoclonal antibodies in clinical practice conditions ranges between 40-60%. We aim to collect at least 300 patients treated with a secondary mAb-CGRP.
Methodology:
Observational analytic study with a retrospective cohort design. Spanish Hospitals with Headache Units or monographic headache consultations participate in the study. In all participant centers, patients carried out a headache diary that assesses the frequency of headache, migraine and acute treatment use.
Study intervention:
A structured questionnaire will be administered to patients, including demographic variables, such as sex, age at migraine onset, age at first mAb-CGRP use, age at second mAb-CGRP use. The following clinical variables were collected type of migraine (episodic / chronic), duration (in months) of high-frequency episodic migraine or chronic migraine; presence and type of aura; number and type of prior prophylactic drugs; mAb-CGRP used in first and second place; reason for discontinuation (lack of efficacy, lack of tolerability); frequency of headache, migraine, acute medication and triptan use per month; presence and type of adverse effects.
All the information was introduced in a standardize data collection form that will be hosted in RedCap.
Recruitment and sampling:
All consecutive patients treated with mAb-CGRP in the participating sites were screened for eligibility, including the administrative databases of all patients treated during the study period.
Data sources:
Paper or electronic health records was used, and structured headache diaries were provided to patients.
Ethics:
The study has been approved by the Ethics Review Board of East Valladolid (PI-22-2658). The study is conducted in accordance with the principles of the Declaration of Helsinki
Statistical Analysis:
First, a descriptive analysis will be carried out. The proportion of patients treated with a monoclonal antibody who receive treatment with a second will be described. A sub-group analysis will be done, depending on whether the reason for the mAb-CGRP switch an effectiveness failure or a tolerability failure was. The 50%, 30%, and 75% response rates will be calculated in the pre-specified study periods, as well as the frequency and type of adverse effects. To evaluate the reduction in days of headache per month, days of migraine, days of use of analgesics, and days of triptans, in the study periods, in relation to the baseline period, the Student's T-test for paired samples will be used. or the Mann-Whitney U, depending on the type of distribution of the sample. Normality of the sample will be assessed with the Kolmogorov-Smirnov test. To evaluate the predictors of response, a logistic regression analysis will be performed in which the independent variable will be the presence of a 50% response between weeks 8-12, and the rest of the study variables will be evaluated first by univariate regression, and after that, analysis multivariate in those with a P value less than 0.1.
Statistical analysis will be performed both by intention to treat (including all patients receiving treatment with a second monoclonal) and per-protocol analysis (those in which the information is complete). In case of missing data, for variables related to treatment, a conservative imputation will be performed using baseline-carried forward, for variables from 8-12 weeks and last-observation carried forward for variables from weeks 8-12.
A stratified analysis will be performed according to whether the reason for discontinuation of the first monoclonal antibody was the failure of effectiveness or lack of tolerance. A stratified analysis will also be performed in treatments between drugs directed against CGRP and their receptor A statistical significance level of 5% will be considered. The correction will be made for multiple comparisons by False Discovery Rate, using the Benjamini-Hochberg method.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 1. Age over 18 years old;
- 2. Confirmed diagnosis of migraine, according to the International Classification of Headche Disorders, 3rd version;
- 3. Treatment with a mAb-CGRP as per responsible physician criteria in routine clinical practice.
Key exclusion criteria (2 listed)
- 1. Unavailability of information prior to the treatment use;
- 2. Other painful disorders that may interfere in the evaluation of the outcomes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
50% response weeks 8-12
Time frame: Between weeks 8-12 of treatment, compared to the month prior to the start of treatment
To evaluate the proportion of patients with migraine treated with a second anti-CGRP monoclonal antibody that achieve a 50% response
30 secondary outcomes
50% response weeks 20-24
Time frame: Between weeks 20-24 of treatment, compared to the month prior to the start of treatment
50% response weeks 32-36
Time frame: Between weeks 32-36 of treatment, compared to the month prior to the start of treatment
50% response weeks 44-48
Time frame: Between weeks 44-48 of treatment, compared to the month prior to the start of treatment
30% response weeks 8-12
Time frame: Between weeks 8-12 of treatment, compared to the month prior to the start of treatment
30% response weeks 20-24
Time frame: Between weeks 20-24 of treatment, compared to the month prior to the start of treatment
30% response weeks 32-36
Time frame: Between weeks 32-36 of treatment, compared to the month prior to the start of treatment
30% response weeks 44-48
Time frame: Between weeks 44-48 of treatment, compared to the month prior to the start of treatment
75% response weeks 8-12
Time frame: Between weeks 8-12 of treatment, compared to the month prior to the start of treatment
75% response weeks 20-24
Time frame: Between weeks 20-24 of treatment, compared to the month prior to the start of treatment
75% response weeks 32-36
Time frame: Between weeks 32-36 of treatment, compared to the month prior to the start of treatment
75% response weeks 44-48
Time frame: Between weeks 44-48 of treatment, compared to the month prior to the start of treatment
Change in headache days per month weeks 8-12
Time frame: Between weeks 8-12 compared to the month prior to starting treatment
Change in migraine days per month weeks 8-12
Time frame: Between weeks 8-12 compared to the month prior to starting treatment
Change in days of use of symptomatic medication per month weeks 8-12
Time frame: Between weeks 8-12 with respect to the month prior to the start of treatment
Change in days of use of triptan per month weeks 8-12
Time frame: Between weeks 8-12 with respect to the month prior to the start of treatment
Change in headache days per month weeks 20-24
Time frame: Between weeks 20-24 compared to the month prior to starting treatment
Change in migraine days per month weeks 20-24
Time frame: Between weeks 20-24 compared to the month prior to starting treatment
Change in days of use of symptomatic medication per month weeks 20-24
Time frame: Between weeks 20-24 with respect to the month prior to the start of treatment
Change in days of use of triptan per month weeks 20-24
Time frame: Between weeks 20-24 with respect to the month prior to the start of treatment
Change in headache days per month weeks 32-36
Time frame: Between weeks 32-36 compared to the month prior to starting treatment
Change in migraine days per month weeks 32-36
Time frame: Between weeks 32-36 compared to the month prior to starting treatment
Change in days of use of symptomatic medication per month weeks 32-36
Time frame: Between weeks 32-36 with respect to the month prior to the start of treatment
Change in days of use of triptan per month weeks 32-36
Time frame: Between weeks 32-36 compared to the month prior to the start of treatment
Change in headache days per month weeks 44-48
Time frame: Between weeks 44-48 compared to the month prior to starting treatment
Change in migraine days per month weeks 44-48
Time frame: Between weeks 44-48 compared to the month prior to starting treatment
Change in days of use of symptomatic medication per month weeks 44-48
Time frame: Between weeks 44-48 with respect to the month prior to the start of treatment
Change in days of use of triptan per month weeks 44-48
Time frame: Between weeks 44-48 compared to the month prior to starting treatment
Frequency and type of adverse events
Time frame: Through study completion, an average of 1 year
Adverse events leading to treatment discontinuation
Time frame: Through study completion, an average of 1 year
Predictors of 50% response
Time frame: Between weeks 8-12, in relation to the month prior to the start of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Background: PubMed 33267788Steiner 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.
- Background: PubMed 33007212Deuschl 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.
- Background: PubMed 30879893GBD 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.
- Background: PubMed 29229375Charles 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.
- Background: PubMed 33773610Ashina 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.
- Background: PubMed 31668411Charles 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.
- Background: PubMed 33567891Drellia 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.
- Background: PubMed 34000847Gantenbein 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.
- Background: PubMed 33941080Vernieri 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.
- Background: PubMed 34644203Overeem 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.
- Background: PubMed 33176918Porta-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.
- Background: PubMed 22550651Ferreira 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.
- Individual participant dataSharing planned: Undecided. Anonymized data may be shared upon reasonable request to the principal investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David García Azorín, MD, PhD principal investigator
Research coordinator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine and Head Pain, run by Hospital Clínico Universitario de Valladolid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David García-Azorín, MD, MSci (+034 665 872228, davilink@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
50% response weeks 8-12 (time frame: Between weeks 8-12 of treatment, compared to the month prior to the start of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05785988, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2024.