NCT05281770

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2022

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 16, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

October 20, 2022

Status Verified

March 1, 2022

Enrollment Period

2.9 years

First QC Date

December 23, 2021

Last Update Submit

October 19, 2022

Conditions

MigraineMigraine With AuraMigraine Without AuraChronic MigraineEpisodic Migraine

Keywords

ErenumabGalcanezumabFremanezumabCGRP-antibodies

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Change in headache days per month (= 4 weeks) from baseline to month 6

    6 months

  • Change in aura days per month (= 4 weeks) from baseline to month 6

    6 months

  • Change in days with acute headache medication per month (= 4 weeks) from baseline to month 6

    6 months

  • Change in days with triptans per month (= 4 weeks) from baseline to month 6

    6 months

  • Change in headache intensity from baseline to month 6

    6 months

  • +3 more secondary outcomes

Other Outcomes (5)

  • Subjective change in quality of life from baseline to month 6

    6 months

  • Change in MIDAS (Migraine Diasability Assessment Questionnaire) scores from baseline to month 6

    6 months

  • Change in impact of headache from baseline to month 6

    6 months

  • +2 more other outcomes

Study Arms (3)

Erenumab

Patients will be treated with this drug within standard of care treatment

Drug: Erenumab

Galcanezumab

Patients will be treated with this drug within standard of care treatment

Drug: Galcanezumab

Fremanezumab

Patients will be treated with this drug within standard of care treatment

Drug: Fremanezumab

Interventions

ErenumabDRUG

treatment with erenumab as chosen by treating physician

Erenumab
FremanezumabDRUG

treatment with fremanezumab as chosen by treating physician

Fremanezumab
GalcanezumabDRUG

treatment with galcanezumab as chosen by treating physician

Galcanezumab

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Male or female adult patients of at least 18 years or older in whom CGRP mabs can be prescribed according to Austrian regulations. These include treatment failure or intolerability / contraindications of at least 3 prophylactic medications. Documentation of treatment in a headache diary on paper or in digital format.

You may qualify if:

  • 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.

You may not qualify if:

  • Off label use of erenumab, fremanezumab or galcanezumab

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Medical University Innsbruck

Innsbruck, Tyrol, A6020, Austria

RECRUITING

Medizinische Universität Wien

Vienna, Vienna, 1090, Austria

RECRUITING

Clinic Hietzing

Vienna, A1130, Austria

RECRUITING

MeSH Terms

Conditions

Migraine DisordersMigraine with AuraMigraine without Aura

Interventions

erenumabfremanezumabgalcanezumab

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Gregor Broessner, Prof

    Medical University Innbruck

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Franz Riederer, Prof

CONTACT

+436803279153franz.riederer@uzh.ch

Karin Zebenholzer, Prof

CONTACT

+43140400karin.zebenholzer@meduniwien.ac.at

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2021

First Posted

March 16, 2022

Study Start

October 1, 2022

Primary Completion

September 1, 2025

Study Completion

December 1, 2025

Last Updated

October 20, 2022

Record last verified: 2022-03

Locations

AU(3)