Headache (Migraine)NCT06812299
Work-related Burden Changes, Quantified with HEADWORK, Among Individuals Treated with Migraine Preventive Therapies.
An observational study of Headache (Migraine), run by IRCCS National Neurological Institute "C. Mondino" Foundation at 3 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Headache (Migraine)
- How many people
- 175 participants
- Where
- 3 sitesItaly
- Study dates
- 1 Jan 2023to 1 Nov 2024
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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)).
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Milan, Italy
IRCSS Mondino Foundation
Pavia, Italy, 27100
Policlinico Universitario Campus Biomedico
Rome, Italy
About this study
Official title: 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.
Read the 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.
- Conditions
- Headache (Migraine)
- Keywords
- PROM, Headwork, migraine related burden, presenteeism, absenteeism, ictal burden, interictal burden, work related burden, burden of disease
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
To evaluate differences in monthly headache days across 12 months of mAbs treatment compared to pre-treatment (continuous variable)
Measured: 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)
To evaluate differences in the intake of acute drugs per month across 12 months of mAbs treatment compared to pre-treatment (continuous variable)
Measured: 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)
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)
Measured: Baseline (T0) - twelve months of mAbs treatment (T12)
Percentage of super-responders among individuals who completed 12 months of mAbs treatment (continuous variable)
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)
Measured: Baseline (T0) - twelve months of mAbs treatment (T12)
Percentage of non responders among individuals who completed 12 months of mAbs treatment (continuous variable)
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)
Measured: 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)
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)
Measured: 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)
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)
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start1 Jan 2023
- Primary completion1 Oct 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Headache (Migraine)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 175 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- IRCCS National Neurological Institute "C. Mondino" Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta, Fondazione Policlinico Universitario Campus Bio-Medico
- Responsible party
- Sponsor
- Investigators
- Licia Grazzi, Dr, Principal investigator, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06812299
- Sponsor's protocol ID
- HEADWORK
- Status last verified
- Feb 2025
- First submitted
- 17 Jan 2025
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38347485Steiner 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.
PubMed 35791285Raggi 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.
PubMed 30203193D'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.
PubMed 31943176GBD 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.
PubMed 33069326Steiner 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.
PubMed 33267788
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Migraine and Work-disability: How Treatment with Monoclonal Antibodies Against CGRP Pathway Could Reduce Work-related Burden Among Migraine Population.
- ClinicalTrials.gov ID
- NCT06812299
- Acronym / sponsor ID
- HEADWORK
- Conditions
- Headache (Migraine)
- Keywords
- PROM, Headwork, migraine related burden, presenteeism, absenteeism, ictal burden, interictal burden, work related burden
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- IRCCS National Neurological Institute "C. Mondino" FoundationUniversity, hospital or other
- Collaborators
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta, Fondazione Policlinico Universitario Campus Bio-Medico
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 6 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (2 listed)
- 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)).
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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)
7 secondary outcomes
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)
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)
Percentage of responders among individuals who completed 12 months of mAbs treatment (continuous variable)
Time frame: 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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Background: PubMed 38347485Lazaro-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.
- Background: PubMed 35791285Steiner 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.
- Background: PubMed 30203193Raggi 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.
- Background: PubMed 31943176D'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.
- Background: PubMed 33069326GBD 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.
- Background: PubMed 33267788Steiner 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Licia Grazzi, Dr principal investigator
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Headache (Migraine), run by IRCCS National Neurological Institute "C. Mondino" Foundation at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06812299, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.