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

NCT06812299 | Completed DMC

• 1 other identifier: HEADWORK
• Study Type: observational
• Target: 175
• Locations: 1 country
• Sites: 3

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.

Conditions

Headache (Migraine)

Keywords

PROM; Headwork; migraine related burden; presenteeism; absenteeism; ictal burden; interictal burden; work related burden; burden of disease

Outcome Measures

Primary Outcomes (2)

• Changes from baseline in HEADWORK part 1 across 12 months of mAbs treatment (continuous variable)

  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)

  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 Outcomes (7)

• 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)

  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)

  Baseline (T0) - twelve months of mAbs treatment (T12)

• Percentage of super-responders among individuals who completed 12 months of mAbs treatment (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)

  Baseline (T0) - twelve months of mAbs treatment (T12)

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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)).

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS National Neurological Institute "C. Mondino" Foundation: lead
• Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta: collaborator
• Fondazione Policlinico Universitario Campus Bio-Medico: collaborator

Study Sites (3)

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Milan, Italy, Italy

Location

IRCSS Mondino Foundation

Pavia, Italy, 27100, Italy

Location

Policlinico Universitario Campus Biomedico

Rome, Italy, Italy

Location

Related Publications (6)

• 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.

  PMID: 38347485 BACKGROUND

• 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.

  PMID: 35791285 BACKGROUND

• 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.

  PMID: 30203193 BACKGROUND

• 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.

  PMID: 31943176 BACKGROUND

• 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.

  PMID: 33069326 BACKGROUND

• 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.

  PMID: 33267788 BACKGROUND

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Licia Grazzi, Dr

  Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: February 6, 2025
• Study Start: January 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: November 1, 2024
• Last Updated: February 6, 2025

Record last verified: 2025-02

Locations

IT (3)