NCT06812299Completed
Work-related Burden Changes, Quantified with HEADWORK, Among Individuals Treated with Migraine Preventive Therapies.
Migraine and Work-disability: How Treatment with Monoclonal Antibodies Against CGRP Pathway Could Reduce Work-related Burden Among Migraine Population.
Source: ClinicalTrials.gov · Last updated 6 Feb 2025
Brief summary (registry, in English)
Migraine is one of the leading causes of disability worldwide among the population under 50. It's economic indirect burden is mostly determined by reduction of work productivity both by absenteeism and presenteeism. Migraine work related burden was usually underestimated by commonly used patients reported outcomes (PROMs), until the introduction of the HEADWORK questionnaire, evaluating working difficulties and the factors that negatively impact work-related tasks. The investigators aim to assess the influence of anti-CGRP monoclonal antibodies on migraine work-related burden by means of this specific PROM.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 175 (actual)
- First submitted
- 17 Jan 2025
- Start date
- 1 Jan 2023
- Primary completion date
- 1 Oct 2024
- Lead sponsor
- IRCCS National Neurological Institute "C. Mondino" Foundation
- Diseases
- Migraine
- NCT number
- NCT06812299
What you commit to
- Study type: Observational
- Participants enrolled: 175
- From 1 Jan 2023 to the primary completion date, 1 Oct 2024
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant diagnosis of medical diseases and/or comorbidities that, in the Investigator's opinion, might interfere with study assessments.
Other
- Subjects with contraindications for use of anti-CGRP mAbs;
Who the study is looking for
- Diagnosis of migraine without aura, migraine with aura, or chronic migraine according to the 3rd edition of the International Classification of Headache Disorder (ICHD-III);
- Patients eligible for treatment with anti-CGRP mAbs according to AIFA prescribing rules (at least 8 migraine days per month in the last three months, MIgraine Disability ASsessment score ≥ 11, and previous failure due to lack of efficacy or tolerability of at least three preventive drugs, among β-blockers, tricyclic antidepressants, antiepileptics, and onabotulinum- toxin-A (this latter only for chronic migraine)).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| IRCSS Mondino Foundation Coordinator of this site? Confirm its status | Pavia | Italy | Unknown status |
| Policlinico Universitario Campus Biomedico Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.