Clinical trial NCT06812299: Work-related Burden Changes, Quantified with HEADWORK, Among Individuals Treated with Migraine Preventive Therapies.
Official title: Migraine and Work-disability: How Treatment with Monoclonal Antibodies Against CGRP Pathway Could Reduce Work-related Burden Among Migraine Population.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Headache (Migraine)
Keywords: PROM
Headwork
migraine related burden
presenteeism
absenteeism
ictal burden
interictal burden
work related burden
burden of disease
Lead sponsor: IRCCS National Neurological Institute "C. Mondino" Foundation
Sponsor class: OTHER
Collaborators: name: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
name: Fondazione Policlinico Universitario Campus Bio-Medico
First posted: 2025-02-06
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes from baseline in HEADWORK part 1 across 12 months of mAbs treatment (continuous variable)
timeFrame: 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)
measure: Changes from baseline in HEADWORK part 2 across 12 months of mAbs treatment compared to pre-treatment (continuous variable)
timeFrame: 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 outcomes:
measure: Differences in monthly headache days across 12 months of mAbs treatment compared to pre-treatment (continuous variable)
timeFrame: 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)
measure: Differences in the intake of acute drugs per month across 12 months of mAbs treatment compared to pre-treatment (continuous variable)
timeFrame: 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)
measure: Percentage of responders among individuals who completed 12 months of mAbs treatment (continuous variable)
timeFrame: Baseline (T0) - twelve months of mAbs treatment (T12)
measure: Percentage of super-responders among individuals who completed 12 months of mAbs treatment (continuous variable)
timeFrame: Baseline (T0) - twelve months of mAbs treatment (T12)
measure: Percentage of non responders among individuals who completed 12 months of mAbs treatment (continuous variable)
timeFrame: Baseline (T0) - twelve months of mAbs treatment (T12)
measure: Differences in HEADWORK part 2 across 12 months of mAbs treatment compared to pre-treatment according to response rate (continuous variable)
timeFrame: 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)
measure: Differences in HEADWORK part 1 across 12 months of mAbs treatment compared to pre-treatment according to response rate (continuous variable)
timeFrame: 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)
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
city: Pavia
country: Italy
facility: IRCSS Mondino Foundation
city: Rome
country: Italy
facility: Policlinico Universitario Campus Biomedico
Study officials:
affiliation: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
name: Licia Grazzi, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lazaro-Hernandez C, Caronna E, Rosell-Mirmi J, Gallardo VJ, Alpuente A, Torres-Ferrus M, Pozo-Rosich P. Early and annual projected savings from anti-CGRP monoclonal antibodies in migraine prevention: a cost-benefit analysis in the working-age population. J Headache Pain. 2024 Feb 12;25(1):21. doi: 10.1186/s10194-024-01727-0.
citation: Steiner TJ, Terwindt GM, Katsarava Z, Pozo-Rosich P, Gantenbein AR, Roche SL, Dell'Agnello G, Tassorelli C. Migraine-attributed burden, impact and disability, and migraine-impacted quality of life: Expert consensus on definitions from a Delphi process. Cephalalgia. 2022 Nov;42(13):1387-1396. doi: 10.1177/03331024221110102. Epub 2022 Jul 5.
citation: Raggi A, Covelli V, Guastafierro E, Leonardi M, Scaratti C, Grazzi L, Bartolini M, Viticchi G, Cevoli S, Pierangeli G, Tedeschi G, Russo A, Barbanti P, Aurilia C, Lovati C, Giani L, Frediani F, Di Fiore P, Bono F, Rapisarda L, D'Amico D. Validation of a self-reported instrument to assess work-related difficulties in patients with migraine: the HEADWORK questionnaire. J Headache Pain. 2018 Sep 10;19(1):85. doi: 10.1186/s10194-018-0914-7.
citation: D'Amico D, Grazzi L, Grignani E, Leonardi M, Sansone E, Raggi A; HEADWORK Study Group. HEADWORK Questionnaire: Why Do We Need a New Tool to Assess Work-Related Disability in Patients With Migraine? Headache. 2020 Feb;60(2):497-504. doi: 10.1111/head.13735. Epub 2020 Jan 13.
citation: GBD 2019 Diseases and Injuries Collaborators. Global burden of 369 diseases and injuries in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2020 Oct 17;396(10258):1204-1222. doi: 10.1016/S0140-6736(20)30925-9.
citation: Steiner TJ, Stovner LJ, Jensen R, Uluduz D, Katsarava Z; Lifting The Burden: the Global Campaign against Headache. Migraine remains second among the world's causes of disability, and first among young women: findings from GBD2019. J Headache Pain. 2020 Dec 2;21(1):137. doi: 10.1186/s10194-020-01208-0. No abstract available.