Work-related Burden Changes, Quantified with HEADWORK, Among Individuals Treated with Migraine Preventive Therapies.

February 1, 2025 updated by: IRCCS National Neurological Institute "C. Mondino" Foundation

Migraine and Work-disability: How Treatment with Monoclonal Antibodies Against CGRP Pathway Could Reduce Work-related Burden Among Migraine Population.

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.

Study Overview

Status

Completed

Conditions

Detailed Description

Migraine attributed burden is a complex and multifaceted entity encompassing patients, families, and society repercussions. It is identified with both an ictal burden, the consequences of pain and associated symptoms on individuals functioning during the migraine attack itself, and interictal burden, namely the limitations experienced between the attacks.

The disease burden is also associated with direct and indirect economic repercussions. According to a recent study, indirect costs mainly related to reduced work productivity, seems especially relevant. Reduction of work productivity may be defined in terms of absenteeism, loss of paid workdays, and presenteeism. The latter condition refers to days of impaired working performance due to migraine, and it is responsible of higher indirect costs. Many factors play a role in the identification of presenteeism, both related to the disease itself and the working place, making it difficult to precisely quantify it.

Commonly used PROMs have several limitations, this is why a specific PROM, known as HEADWORK questionnaire, was created to assess work-related difficulties and impairment in migraine individuals. HEADWORK is a 17-item, two-scale questionnaire that evaluates working difficulties in general or specific skills (such as problems solving or starting new tasks), and the factors that negatively impact work-related tasks (such as noise and brightness of the workplace).

Monoclonal antibodies directed against the Calcitonin Gene Related Peptide pathway (mAbs) represent a new targeted migraine preventive treatment. A recent study assessed the impact of mAbs in working-age migraine individuals, showing that the drug costs are compensated by reductions in both absenteeism and presenteeism, starting within the first three months of mAbs treatment Primary outcome is to assess changes in HEADWORK questionnaire, reflecting work-related difficulties, across one year treatment with mAbs in a population of migraine individuals.

Study Type

Observational

Enrollment (Actual)

175

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy
        • Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
      • Pavia, Italy, 27100
        • IRCSS Mondino Foundation
      • Rome, Italy
        • Policlinico Universitario Campus Biomedico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients suffering from episodic and chronic migraine and eligible for treatment with anti-CGRP mAbs according to AIFA prescribing rules enrolled in the outpatients clinic of IRCCS C.Besta (Milan), IRCCS Mondino Foundation (Pavia) and Campus Biomedico (Rome)

Description

Inclusion Criteria:

  • 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)).

Exclusion Criteria:

  • Subjects with contraindications for use of anti-CGRP mAbs;
  • Concomitant diagnosis of medical diseases and/or comorbidities that, in the Investigator's opinion, might interfere with study assessments.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
High frequency episodic or chronic migraine
Patients affected by high frequency episodic migraine or chronic migraine with or without aura according to ICHD-III criteria who received treatment with monoclonal antibodies directed against the CGRP pathway.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes from baseline in HEADWORK part 1 across 12 months of mAbs treatment (continuous variable)
Time Frame: Baseline (T0) - three months of mAbs treatment (T3) - six months of mAbs treatment (T6) - nine months of mAbs treatment (T9) - twelve months of mAbs treatment (T12)
Changes from baseline in HEADWORK part 1 (11 item addressing migraine impact on work-related difficulties in general or specific skills) across 12 months of mAbs treatment compared to pre-treatment (continuous variable)
Baseline (T0) - three months of mAbs treatment (T3) - six months of mAbs treatment (T6) - nine months of mAbs treatment (T9) - twelve months of mAbs treatment (T12)
Changes from baseline in HEADWORK part 2 across 12 months of mAbs treatment compared to pre-treatment (continuous variable)
Time Frame: Baseline (T0) - three months of mAbs treatment (T3) - six months of mAbs treatment (T6) - nine months of mAbs treatment (T9) - twelve months of mAbs treatment (T12)
Changes from baseline in HEADWORK (6 items addressing the factors contributing to working difficulties, defined as negative impact on work tasks) across 12 months of mAbs treatment compared to pre-treatment (continuous variable)
Baseline (T0) - three months of mAbs treatment (T3) - six months of mAbs treatment (T6) - nine months of mAbs treatment (T9) - twelve months of mAbs treatment (T12)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in monthly headache days across 12 months of mAbs treatment compared to pre-treatment (continuous variable)
Time Frame: Baseline (T0) - three months of mAbs treatment (T3) - six months of mAbs treatment (T6) - nine months of mAbs treatment (T9) - twelve months of mAbs treatment (T12)
To evaluate differences in monthly headache days across 12 months of mAbs treatment compared to pre-treatment (continuous variable)
Baseline (T0) - three months of mAbs treatment (T3) - six months of mAbs treatment (T6) - nine months of mAbs treatment (T9) - twelve months of mAbs treatment (T12)
Differences in the intake of acute drugs per month across 12 months of mAbs treatment compared to pre-treatment (continuous variable)
Time Frame: Baseline (T0) - three months of mAbs treatment (T3) - six months of mAbs treatment (T6) - nine months of mAbs treatment (T9) - twelve months of mAbs treatment (T12)
To evaluate differences in the intake of acute drugs per month across 12 months of mAbs treatment compared to pre-treatment (continuous variable)
Baseline (T0) - three months of mAbs treatment (T3) - six months of mAbs treatment (T6) - nine months of mAbs treatment (T9) - twelve months of mAbs treatment (T12)
Percentage of responders among individuals who completed 12 months of mAbs treatment (continuous variable)
Time Frame: Baseline (T0) - twelve months of mAbs treatment (T12)
To evaluate the percentage of responders among individuals who completed 12 months of mAbs treatment, identified as those individuals who achieved a reduction of monthly headache frequency between 50% and 75% compared to baseline (continuous variable)
Baseline (T0) - twelve months of mAbs treatment (T12)
Percentage of super-responders among individuals who completed 12 months of mAbs treatment (continuous variable)
Time Frame: Baseline (T0) - twelve months of mAbs treatment (T12)
To evaluate the percentage of super-responders among individuals who completed 12 months of mAbs treatment, identified as those individuals who achieved a reduction of monthly headache frequency >=75% compared to baseline (continuous variable)
Baseline (T0) - twelve months of mAbs treatment (T12)
Percentage of non responders among individuals who completed 12 months of mAbs treatment (continuous variable)
Time Frame: Baseline (T0) - twelve months of mAbs treatment (T12)
To evaluate the percentage of non responders among individuals who completed 12 months of mAbs treatment, identified as those individuals who achieved a reduction of monthly headache frequency <50% compared to baseline (continuous variable)
Baseline (T0) - twelve months of mAbs treatment (T12)
Differences in HEADWORK part 2 across 12 months of mAbs treatment compared to pre-treatment according to response rate (continuous variable)
Time Frame: Baseline (T0) - three months of mAbs treatment (T3) - six months of mAbs treatment (T6) - nine months of mAbs treatment (T9) - twelve months of mAbs treatment (T12)
To evaluate the differences in HEADWORK part 2 across 12 months of mAbs treatment compared to pre-treatment in the non-responder, responder and super-responder group (continuous variable)
Baseline (T0) - three months of mAbs treatment (T3) - six months of mAbs treatment (T6) - nine months of mAbs treatment (T9) - twelve months of mAbs treatment (T12)
Differences in HEADWORK part 1 across 12 months of mAbs treatment compared to pre-treatment according to response rate (continuous variable)
Time Frame: Baseline (T0) - three months of mAbs treatment (T3) - six months of mAbs treatment (T6) - nine months of mAbs treatment (T9) - twelve months of mAbs treatment (T12)
To evaluate the differences in HEADWORK part 1 across 12 months of mAbs treatment compared to pre-treatment in the non-responder, responder and super-responder group (continuous variable)
Baseline (T0) - three months of mAbs treatment (T3) - six months of mAbs treatment (T6) - nine months of mAbs treatment (T9) - twelve months of mAbs treatment (T12)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS National Neurological Institute "C. Mondino" Foundation

Collaborators

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Fondazione Policlinico Universitario Campus Bio-Medico

Investigators

  • Principal Investigator: Licia Grazzi, Dr, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

October 1, 2024

Study Completion (Actual)

November 1, 2024

Study Registration Dates

First Submitted

January 17, 2025

First Submitted That Met QC Criteria

February 1, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 1, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEADWORK

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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