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

Completed

• Conditions: Headache (Migraine)

• Registration Number: NCT06812299
• Lead Sponsor: IRCCS National Neurological Institute "C. Mondino" Foundation

Brief Summary

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.

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 Timeline

• Study Start: 2023-01-01
• Primary Completion: 2024-10-01
• Study Completion: 2024-11-01
• Study First Submitted: 2025-01-17
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-01
• Last Update Submitted: 2025-02-01
• Study First Posted: 2025-02-06
• Last Update Posted: 2025-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 175

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes from baseline in HEADWORK part 1 across 12 months of mAbs 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 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)
Changes from baseline in HEADWORK part 2 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 (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)

Secondary Outcome Measures

Name	Time	Method
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)	To evaluate differences in monthly headache days across 12 months of mAbs treatment compared to pre-treatment (continuous variable)
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)	To evaluate differences in the intake of acute drugs per month across 12 months of mAbs treatment compared to pre-treatment (continuous variable)
Percentage of responders among individuals who completed 12 months of mAbs treatment (continuous variable)	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)
Percentage of super-responders among individuals who completed 12 months of mAbs treatment (continuous variable)	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)
Percentage of non responders among individuals who completed 12 months of mAbs treatment (continuous variable)	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)
Differences in HEADWORK part 2 across 12 months of mAbs treatment compared to pre-treatment according to response rate (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)	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)
Differences in HEADWORK part 1 across 12 months of mAbs treatment compared to pre-treatment according to response rate (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)	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)

Trial Locations

Locations (3)

Policlinico Universitario Campus Biomedico; 🇮🇹 Rome, Italy

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta; 🇮🇹 Milan, Italy

IRCSS Mondino Foundation; 🇮🇹 Pavia, Italy