Monoclonal CGRP Antibodies for Migraine Prevention - a Nationwide Real Life Study

Migraine Clinical Trial

Official title:

Non-interventional Study of the Austrian Headache Society: Monoclonal CGRP Antibodies for Migraine Prevention a Nationwide Real Life Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05281770
• Other study ID #: EK Nr: 1122/2021
• Status: Recruiting
• Start date: October 1, 2022
• Est. completion date: December 1, 2025

Study information

• Verified date: March 2022
• Source: Austrian Migraine Registry Collaboration
• Contact: Franz Riederer, Prof
• Phone: +436803279153
• Email: franz.riederer[@]uzh.ch
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The present non-interventional study on migraine prevention with monoclonal CGRP antibodies adresses questions concering safety, swichting from one CGRP mab to another, efficacy on auras in the real world setting.

Description:

Introduction:

Monoclonal antibodies against calcitonin gene-related peptide (CGRP) or its receptor (CGRP-R) are an effective option for the preventative treatment in episodic and chronic migraine. All monoclonal antibodies against CGRP or CGRP-R have been proven efficacious in all various treatment endpoints (i.e. reduction of MMDs, improvement in Quality of Life etc.) in randomized phase 3 trials and were therefore approved by FDA and EMA. However, real world clinical experience/data in "non-study" patients is lacking as is data on long-term efficacy, elderly or data on switchers between antibodies that cannot be derived out of previous trials.

Phase 3 and 4 studies have addressed issues of efficacy and safety in highly selected clinical study populations and so far no safety concerns have emerged. However, long-term data are limited to a maximum period of 5 years and have been acquired in selected study cohorts probably not reflecting a "real world" patient population. It is a main goal of the study to acquire data on safety and efficacy in a real world setting where patients will be less selected than in clinical studies in terms of accompanying diseases or comorbidities. Another knowledge gap concerns the optimal procedure when switching the patient from one anti-CGRP therapy to another or being paused (and re-initiated) after a first successful treatment period. With specific evidence lacking, it is frequently recommended to wait several half-lives before initiating the next anti-CGRP therapy. Another unresolved question is whether non-responders to CGRP ligand blockers may respond to CGRP-receptor blockers and vice versa. While efficacy of anti-CGRP therapies has been demonstrated for migraine with and without aura, possible effects on the migraine auras per se have not been reported.

Phase 4 studies (non-interventional studies) on treatment with anti-CGRP therapies are being conducted in several countries in Europe. These are, however, limited to one specific substance. The proposed project will allow collecting data on the use of erenumab, fremanezumab, and galcanezumab on a nation- wide basis up to 36 months in a real-life setting.

The following knowledge should emerge from the registry:

Anti-CGRP therapies can be safely used in a wide spectrum of migraine patients with comorbidities and accompanying diseases over a long time period. There will be evidence how patients can be switched from one CGRP antibody to another. There will be an evidence base to switch anti-CGRP-therapies from ligand- to receptor- blockers or vice versa. Additionally the question whether a mAB even if effective should be paused or not after 1 year of treatment and what effect this pause might have will be addressed subsequently.

Methods Collected data will be entered in an electronic platform provided by Health Austria (https://goeg.at/) which has long-term experience in conducting and maintaining nation-wide registries, e.g. the Austrian Stroke Registry.

Non interventional study - The decision for therapy with an anti-CGRP monoclonal antibody/ CGRP antagonist is made by the treating physician and is NOT part of the Study. The study was approved by the relevant ethics committees and registered at a platform of the Austrian Agency for Health an Nutrition Safety at https://forms.ages.at/nis/. All patients treated in the headache centers are keeping headache diaries on paper or in electronic form as a standard of care procedure. Prospective and retrospective data collection from electronic charts is possible. Data are collected during routine visits which are scheduled in 3 months intervals. Collected data will be entered in an electronic platform provided by Health Austria (https://goeg.at/) in an anonymized form.

Study funding: Scientific reports concerning fremanezumab will be provideded to TEVA Austria, reports on erenumab to Novartis Austria and on galcanezumab to Eli Lilly Austria, based on financial compensation agreements.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: December 1, 2025
• Est. primary completion date: September 1, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria (all of the follwing)

• episodic or chronic migraine with or without aura

• erenumab, fremanezumab or galcanezumab is prescribed as a standard of care treatment by treating physician Eptinezumab may be included as soon as available in Austria.

Exclusion Criteria:

• Off label use of erenumab, fremanezumab or galcanezumab

Related Conditions & MeSH terms

• Chronic Migraine
• Episodic Migraine
• Migraine
• Migraine Disorders
• Migraine with Aura
• Migraine Without Aura

Intervention

Drug:
• Erenumab
treatment with erenumab as chosen by treating physician
• Fremanezumab
treatment with fremanezumab as chosen by treating physician
• Galcanezumab
treatment with galcanezumab as chosen by treating physician

Locations

Country	Name	City	State
Austria	Medical University Innsbruck	Innsbruck	Tirol
Austria	Clinic Hietzing	Vienna
Austria	Medizinische Universität Wien	Wien	Vienna

Sponsors (4)

Lead Sponsor	Collaborator
Austrian Migraine Registry Collaboration	Austrian Headache Society, Medical University Innsbruck, Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Subjective change in quality of life from baseline to month 6	3 point scale: improved, unchanged, worse	6 months
Other	Change in MIDAS (Migraine Diasability Assessment Questionnaire) scores from baseline to month 6	Migraine Disability Assessment Questionnaire. A higher Score indicates more disability. mnimum = 0, maximum =270	6 months
Other	Change in impact of headache from baseline to month 6	Questionnaire. Higher scores indicate more impact of headache. Minmum= 36, maximum =38	6 months
Other	Adverse events	Any treatment emergent adverse events, Causality according to FDA rating: unlikely, possible, probable	Up to 36 months. Assessment every 3 months, may differ between study centers.
Other	Serious adverse events	Definiation and causality according to FDA	Up to 36 months. Assessment every 3 months, may differ between study centers. Baseline refers to the 4 weeks interval before treatment start
Primary	Change in Migraine days per month (= 4 weeks) from baseline to month 6	Either of the following: (i) patient has treated headache with a triptan (ii) criteria C+ D for migraine without aura are fulfilled (iii) criteria B+C for migraine with aura are fulfilled	6 months
Secondary	Change in headache days per month (= 4 weeks) from baseline to month 6	Any day with headache	6 months
Secondary	Change in aura days per month (= 4 weeks) from baseline to month 6	Any day with at least one migraine aura	6 months
Secondary	Change in days with acute headache medication per month (= 4 weeks) from baseline to month 6	Any days on which medication against migraine was taken by the patient	6 months
Secondary	Change in days with triptans per month (= 4 weeks) from baseline to month 6	Any days on which triptans medication were taken by the patient	6 months
Secondary	Change in headache intensity from baseline to month 6	Usual intensity of headche attacks on a numerical rating scale from 1 -10. Higher numbers indicate more severe headache attacks	6 months
Secondary	Change in unpleasantness of aura from baseline to month 6	Usual unpleasantness of aura on a numerical rating scale from 1 -10. Higher numbers indicate more unpleasantness.	6 months
Secondary	Change in migraine duration from baseline to month 6	Usual duration of migraine headache attack	6 months
Secondary	Change in migraine aura duration from baseline to month 6	Usual duration of migraine aura	6 months