MigraineEre-MIDASNCT05442008
Predictive Role of MIDAS Reduction at 3 Months for Erenumab Treatment
An observational study of Migraine, run by IRCCS National Neurological Institute "C. Mondino" Foundation at 1 site in Italy.
Trial summary
In 2021, the Italian Medicines Agency approved reimbursement of monoclonal antibodies targeting the CGRP pathway (CGRP-mAbs) as preventive therapies for patients with high frequency and chronic migraine (CM). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- Erenumab 70/140 mg s.c.
- How many people
- 53 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2018to 1 Jan 2021
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic migraine with clinical features in agreement with AIFA regulations for CGRP-mAbs prescription.
Who may be able to join
- diagnosis of CM according to ICHD-3 criteria for at least 12 months prior to enrollment;
- completion of a full headache diary in the 3 months preceding the enrollment; compliance to complete a daily headache diary for 1 year;
- previous failure of at least 3 classes of preventive treatments among beta-blockers, antiepileptic drugs, antidepressants, or onabotulinumtoxin-A;
- MIDAS score > 11.
Who cannot join
- severe cardiologic comorbidities;
- pregnancy and breastfeeding;
- previous adverse reaction to latex
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Early MIDAS Reduction at 3 Months as Predictor of Long-term Erenumab Treatment in Chronic Migraine: a Real-life, Open-label, Trial
In 2021, the Italian Medicines Agency approved reimbursement of monoclonal antibodies targeting the CGRP pathway (CGRP-mAbs) as preventive therapies for patients with high frequency and chronic migraine (CM). A moderate to severe disability, quantified as a MIgraine Disability ASsessment (MIDAS) score > or equal to 11, is required for prescription. Score reduction of at least 50% after the first three months (T3) is mandatory to continue treatment.
This is a prospective real-life, open-label study. CM patients will be treated with erenumab 70-140 mg subcutaneous injections every 28 days for one year (T13). We will record the following parameters: demographic and headache features, monthly migraine and headache days (MMDs and MHDs respectively), days and doses of symptomatic intake. Patients also completed questionnaires evaluating migraine related disability (MIDAS and HIT-6), psychological comorbidities (HADS-A and HADS-D), quality of life (MSQ and 0 to 100 visual analogue scale) and allodynia (ASC-12).
At least a 50% reduction in MIDAS score or MMDs after 3 months of treatment will be testedas predictors of long-term clinical outcome.
Read the detailed description
Monoclonal antibodies directed against the Calcitonin Gene Related Peptide (CGRP-mAbs) pathway are a silver lining in the setting of migraine therapies, partly overcoming the issues related to poor effectiveness and tolerability of previous preventive treatments.
These drugs act on the CGRP pathway, a key vasoactive neuropeptide in migraine pathophysiology involved in activation and sensitization of afferent trigeminal nociceptors of the trigeminovascular system. Galcanezumab, fremanezumab and eptinezumab target the CGRP ligand, while erenumab, a fully human IgG2, targets its receptor. mAbs efficacy and safety have been largely documented in multiple randomized clinical trials, open-label studies as well as in the real-world setting.
The Italian Medicines Agency (AIFA) approved a 12-month period of mAbs treatment reimbursement through the National Health Service for migraine patients with the following features: i) at least 8 migraine days per month in the last three months, ii) a MIgraine Disability ASsessment (MIDAS) score ≥ 11, and iii) previous failure for inefficacy or no tolerability of at least three preventive drugs, among β-blockers, tricyclic antidepressants, antiepileptics, and onabotulinumtoxin-A for chronic migraine (CM).
In addition, a reduction of at least 50% of MIDAS score after 3 and 6 months of treatment is the only mandatory step to continue beyond these check-points. Thus, MIDAS score is pivotal for mAbs treatment initiation and continuation. MIDAS is a self-administered five-item questionnaire focusing on reduction in home and workplace productivity, and a score > 11 identify a set of patients with a moderate to severe disability. A MIDAS score reduction during mAbs treatment was demonstrated in the short and long term period, but its role as predictor of mAbs clinical outcome has never been consistently studied. A major concern for using a single parameter as a mandatory criterion for prescription and continuation of a preventive treatment is the limited ability to capture the multifaced disability that characterize the migraine spectrum. On the other side, reduction in monthly migraine days (MMDs) represents a pivotal outcome for clinical trials and physicians, but this may not completely highlight the patients' perspective.
The investigators consecutively screened migraine patients attending the outpatient clinic of the Headache Science \& Neurorehabilitation Center of the IRCCS Mondino Foundation (Pavia, Italy).
The patients underwent a 1-year treatment with erenumab subcutaneous administration every 28 days (13 administrations) outside of the AIFA reimbursement program within a compassionate program.
During a baseline visit (T0), a neurologist with expertise in the headache field provided clinical indication to erenumab. At T0, the investigators checked the inclusion/exclusion criteria and the headache diaries of the three preceding months, and performed a full neurologic and general examination and a thorough anamnestic evaluation.
Patients who agreed to participate in the study signed a written informed consent and completed the baseline procedures, including clinical and demographic data recording and completion of a set of questionnaires to assess migraine related disability (MIDAS and HIT-6), psychological comorbidities (HADS-A and HADS-D), quality of life (MSQ), a self-perception of general health (0 to 100 visual analogue scale), and allodynia (ASC-12).
The first erenumab administration (70 mg) was delivered in the hospital setting at T0. After the first administration the patients were observed for 2 hours to monitor possible acute adverse events. The patients were then instructed to perform the following self-administrations of erenumab at home every 28 days (T1 to T12).
The patients returned to the Center every 12 weeks for the follow-up visits (T3 - T6 - T9 - T12), and at T13 for the last visit of the protocol. Monthly headache days (MHDs), monthly migraine days (MMDs), and days of acute drug intake were prospectively recorded in a paper headache diary. At each follow-up visit, the patients completed the same study procedures and clinical scales previously defined. At T3, erenumab dosage was increased in 72 patients up to 140 mg, according to the physician's judgment. All patients were allowed to keep their oral preventive medication with a stable dose across all study period.
The primary outcome was to evaluate the role of MIDAS reduction of at least 50% at T3 (MIDASRes) as a predictor of the long-term clinical outcome. As co-primary outcome, the investigators explored the role of early (T3) 50% MMDs reduction (MMDRes) as predictor of long-term efficacy.
In addition, the investigators evaluated the association between MIDASRes as well as MMDRes and the percentage of patients with a reduction in MMDs of at least 50% in the last 4 weeks of observation period (T13) when compared to baseline (RespondersT13). ResponderT13 were defined according to the IHS Guidelines for clinical trials involving CM patients.
As secondary outcomes, the investigators searched for possible associations between baseline clinical/demographic features and long-term efficacy of erenumab treatment, while, as exploratory outcomes, we described 1-year change in migraine-related disability, anxiety and depression severity, allodynia, and quality of life. The study was approved by the local Ethics Committee (P-20190105434).
- Conditions
- Migraine
- Being tested
- Erenumab 70/140 mg s.c.
- Keywords
- Migraine, Headache, CGRP, Monoclonal antibodies, Pain, Chronic migraine
- Medical subject headings
- Migraine Disorders, Headache, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erenumab 70/140 mg s.c.Drug
Monoclonal antibody directed against the receptor of the Calcitonin Gene Related Peptide (CGRP)
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive role of early MIDAS score reduction
To evaluate whether a >50% reduction in the MIDAS score at T3 (MIDAS-Res) is predictive of a more pronounced reduction in MMDs during a 1-year erenumab treatment.
Measured: Reduction in MMDs across 1-year treatment period
Predictive role of early MMDs score reduction
To evaluate whether a >50% reduction in the monthly migraine days (MMDs) at T3 (MMD-Res) is predictive of a more pronounced reduction in MMDs during a 1-year erenumab treatment.
Measured: Reduction in MMDs across 1-year treatment period
Secondary outcomes (1)
Association between MIDAS-Res or MMD-Res and Responders at the end of the 1-year erenumab treatment
Association between MIDAS-Res or MMD-Res and the percentage of patients with a reduction in MMDs of at least 50% in the last 4 weeks of observation period (T13) when compared to baseline (RespondersT13).
Measured: MIDAS-Res and MMD-Res defined after three months of erenumab treatment. ResponderT13 defined in the last 4 weeks of the 1-year erenumab treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start1 Dec 2018
- Primary completion1 Jan 2020
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies 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
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS National Neurological Institute "C. Mondino" Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05442008
- Sponsor's protocol ID
- ERENUMAB2022
- Acronym
- Ere-MIDAS
- Status last verified
- Jun 2022
- First submitted
- 28 Jun 2022
- Last updated
- 1 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Hepp Z, Dodick DW, Varon SF, Gillard P, Hansen RN, Devine EB. Adherence to oral migraine-preventive medications among patients with chronic migraine. Cephalalgia. 2015 May;35(6):478-88. doi: 10.1177/0333102414547138. Epub 2014 Aug 27.
PubMed 25164920Edvinsson L, Haanes KA, Warfvinge K, Krause DN. CGRP as the target of new migraine therapies - successful translation from bench to clinic. Nat Rev Neurol. 2018 Jun;14(6):338-350. doi: 10.1038/s41582-018-0003-1.
PubMed 29691490Scuteri D, Adornetto A, Rombola L, Naturale MD, Morrone LA, Bagetta G, Tonin P, Corasaniti MT. New Trends in Migraine Pharmacology: Targeting Calcitonin Gene-Related Peptide (CGRP) With Monoclonal Antibodies. Front Pharmacol. 2019 Apr 9;10:363. doi: 10.3389/fphar.2019.00363. eCollection 2019.
PubMed 31024319Tepper S, Ashina M, Reuter U, Brandes JL, Dolezil D, Silberstein S, Winner P, Leonardi D, Mikol D, Lenz R. Safety and efficacy of erenumab for preventive treatment of chronic migraine: a randomised, double-blind, placebo-controlled phase 2 trial. Lancet Neurol. 2017 Jun;16(6):425-434. doi: 10.1016/S1474-4422(17)30083-2. Epub 2017 Apr 28.
PubMed 28460892Barbanti P, Aurilia C, Egeo G, Fofi L, Cevoli S, Colombo B, Filippi M, Frediani F, Bono F, Grazzi L, Salerno A, Mercuri B, Carnevale A, Altamura C, Vernieri F. Erenumab in the prevention of high-frequency episodic and chronic migraine: Erenumab in Real Life in Italy (EARLY), the first Italian multicenter, prospective real-life study. Headache. 2021 Feb;61(2):363-372. doi: 10.1111/head.14032. Epub 2020 Dec 18.
PubMed 33337544Sacco S, Amin FM, Ashina M, Bendtsen L, Deligianni CI, Gil-Gouveia R, Katsarava Z, MaassenVanDenBrink A, Martelletti P, Mitsikostas DD, Ornello R, Reuter U, Sanchez-Del-Rio M, Sinclair AJ, Terwindt G, Uluduz D, Versijpt J, Lampl C. European Headache Federation guideline on the use of monoclonal antibodies targeting the calcitonin gene related peptide pathway for migraine prevention - 2022 update. J Headache Pain. 2022 Jun 11;23(1):67. doi: 10.1186/s10194-022-01431-x.
PubMed 35690723Stewart WF, Lipton RB, Kolodner KB, Sawyer J, Lee C, Liberman JN. Validity of the Migraine Disability Assessment (MIDAS) score in comparison to a diary-based measure in a population sample of migraine sufferers. Pain. 2000 Oct;88(1):41-52. doi: 10.1016/S0304-3959(00)00305-5.
PubMed 11098098Iannone LF, Fattori D, Benemei S, Chiarugi A, Geppetti P, De Cesaris F. Long-Term Effectiveness of Three Anti-CGRP Monoclonal Antibodies in Resistant Chronic Migraine Patients Based on the MIDAS score. CNS Drugs. 2022 Feb;36(2):191-202. doi: 10.1007/s40263-021-00893-y. Epub 2022 Feb 11.
PubMed 35146696Lipton RB, Tepper SJ, Reuter U, Silberstein S, Stewart WF, Nilsen J, Leonardi DK, Desai P, Cheng S, Mikol DD, Lenz R. Erenumab in chronic migraine: Patient-reported outcomes in a randomized double-blind study. Neurology. 2019 May 7;92(19):e2250-e2260. doi: 10.1212/WNL.0000000000007452. Epub 2019 Apr 17.
PubMed 30996060Ashina M, Goadsby PJ, Reuter U, Silberstein S, Dodick DW, Xue F, Zhang F, Paiva da Silva Lima G, Cheng S, Mikol DD. Long-term efficacy and safety of erenumab in migraine prevention: Results from a 5-year, open-label treatment phase of a randomized clinical trial. Eur J Neurol. 2021 May;28(5):1716-1725. doi: 10.1111/ene.14715. Epub 2021 Jan 20.
PubMed 33400330Goadsby PJ, Reuter U, Lanteri-Minet M, Paiva da Silva Lima G, Hours-Zesiger P, Fernandes C, Wen S, Tenenbaum N, Kataria A, Ferrari MD, Klatt J. Long-term Efficacy and Safety of Erenumab: Results From 64 Weeks of the LIBERTY Study. Neurology. 2021 May 31;96(22):e2724-e2735. doi: 10.1212/WNL.0000000000012029.
PubMed 33910942Tassorelli C, Diener HC, Dodick DW, Silberstein SD, Lipton RB, Ashina M, Becker WJ, Ferrari MD, Goadsby PJ, Pozo-Rosich P, Wang SJ; International Headache Society Clinical Trials Standing Committee. Guidelines of the International Headache Society for controlled trials of preventive treatment of chronic migraine in adults. Cephalalgia. 2018 Apr;38(5):815-832. doi: 10.1177/0333102418758283. Epub 2018 Mar 4.
PubMed 29504482Alpuente A, Gallardo VJ, Caronna E, Torres-Ferrus M, Pozo-Rosich P. In search of a gold standard patient-reported outcome measure to use in the evaluation and treatment-decision making in migraine prevention. A real-world evidence study. J Headache Pain. 2021 Dec 13;22(1):151. doi: 10.1186/s10194-021-01366-9.
PubMed 34903177Iannone LF, Fattori D, Benemei S, Chiarugi A, Geppetti P, De Cesaris F. Predictors of sustained response and effects of the discontinuation of anti-calcitonin gene related peptide antibodies and reinitiation in resistant chronic migraine. Eur J Neurol. 2022 May;29(5):1505-1513. doi: 10.1111/ene.15260. Epub 2022 Feb 13.
PubMed 35098620Vernieri F, Brunelli N, Messina R, Costa CM, Colombo B, Torelli P, Quintana S, Cevoli S, Favoni V, d'Onofrio F, Egeo G, Rao R, Filippi M, Barbanti P, Altamura C. Discontinuing monoclonal antibodies targeting CGRP pathway after one-year treatment: an observational longitudinal cohort study. J Headache Pain. 2021 Dec 18;22(1):154. doi: 10.1186/s10194-021-01363-y.
PubMed 34922444
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Early MIDAS Reduction at 3 Months as Predictor of Long-term Erenumab Treatment in Chronic Migraine: a Real-life, Open-label, Trial
- ClinicalTrials.gov ID
- NCT05442008
- Acronym / sponsor ID
- Ere-MIDAS / ERENUMAB2022
- Conditions
- Migraine
- Keywords
- Migraine, Headache, CGRP, Monoclonal antibodies, Pain, Chronic migraine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- IRCCS National Neurological Institute "C. Mondino" FoundationUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 1 Jul 2022 (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.
In 2021, the Italian Medicines Agency approved reimbursement of monoclonal antibodies targeting the CGRP pathway (CGRP-mAbs) as preventive therapies for patients with high frequency and chronic migraine (CM). A moderate to severe disability, quantified as a MIgraine Disability ASsessment (MIDAS) score > or equal to 11, is required for prescription. Score reduction of at least 50% after the first three months (T3) is mandatory to continue treatment.
This is a prospective real-life, open-label study. CM patients will be treated with erenumab 70-140 mg subcutaneous injections every 28 days for one year (T13). We will record the following parameters: demographic and headache features, monthly migraine and headache days (MMDs and MHDs respectively), days and doses of symptomatic intake. Patients also completed questionnaires evaluating migraine related disability (MIDAS and HIT-6), psychological comorbidities (HADS-A and HADS-D), quality of life (MSQ and 0 to 100 visual analogue scale) and allodynia (ASC-12).
At least a 50% reduction in MIDAS score or MMDs after 3 months of treatment will be testedas predictors of long-term clinical outcome.
Detailed description
Monoclonal antibodies directed against the Calcitonin Gene Related Peptide (CGRP-mAbs) pathway are a silver lining in the setting of migraine therapies, partly overcoming the issues related to poor effectiveness and tolerability of previous preventive treatments.
These drugs act on the CGRP pathway, a key vasoactive neuropeptide in migraine pathophysiology involved in activation and sensitization of afferent trigeminal nociceptors of the trigeminovascular system. Galcanezumab, fremanezumab and eptinezumab target the CGRP ligand, while erenumab, a fully human IgG2, targets its receptor. mAbs efficacy and safety have been largely documented in multiple randomized clinical trials, open-label studies as well as in the real-world setting.
The Italian Medicines Agency (AIFA) approved a 12-month period of mAbs treatment reimbursement through the National Health Service for migraine patients with the following features: i) at least 8 migraine days per month in the last three months, ii) a MIgraine Disability ASsessment (MIDAS) score ≥ 11, and iii) previous failure for inefficacy or no tolerability of at least three preventive drugs, among β-blockers, tricyclic antidepressants, antiepileptics, and onabotulinumtoxin-A for chronic migraine (CM).
In addition, a reduction of at least 50% of MIDAS score after 3 and 6 months of treatment is the only mandatory step to continue beyond these check-points. Thus, MIDAS score is pivotal for mAbs treatment initiation and continuation. MIDAS is a self-administered five-item questionnaire focusing on reduction in home and workplace productivity, and a score > 11 identify a set of patients with a moderate to severe disability. A MIDAS score reduction during mAbs treatment was demonstrated in the short and long term period, but its role as predictor of mAbs clinical outcome has never been consistently studied. A major concern for using a single parameter as a mandatory criterion for prescription and continuation of a preventive treatment is the limited ability to capture the multifaced disability that characterize the migraine spectrum. On the other side, reduction in monthly migraine days (MMDs) represents a pivotal outcome for clinical trials and physicians, but this may not completely highlight the patients' perspective.
The investigators consecutively screened migraine patients attending the outpatient clinic of the Headache Science \& Neurorehabilitation Center of the IRCCS Mondino Foundation (Pavia, Italy).
The patients underwent a 1-year treatment with erenumab subcutaneous administration every 28 days (13 administrations) outside of the AIFA reimbursement program within a compassionate program.
During a baseline visit (T0), a neurologist with expertise in the headache field provided clinical indication to erenumab. At T0, the investigators checked the inclusion/exclusion criteria and the headache diaries of the three preceding months, and performed a full neurologic and general examination and a thorough anamnestic evaluation.
Patients who agreed to participate in the study signed a written informed consent and completed the baseline procedures, including clinical and demographic data recording and completion of a set of questionnaires to assess migraine related disability (MIDAS and HIT-6), psychological comorbidities (HADS-A and HADS-D), quality of life (MSQ), a self-perception of general health (0 to 100 visual analogue scale), and allodynia (ASC-12).
The first erenumab administration (70 mg) was delivered in the hospital setting at T0. After the first administration the patients were observed for 2 hours to monitor possible acute adverse events. The patients were then instructed to perform the following self-administrations of erenumab at home every 28 days (T1 to T12).
The patients returned to the Center every 12 weeks for the follow-up visits (T3 - T6 - T9 - T12), and at T13 for the last visit of the protocol. Monthly headache days (MHDs), monthly migraine days (MMDs), and days of acute drug intake were prospectively recorded in a paper headache diary. At each follow-up visit, the patients completed the same study procedures and clinical scales previously defined. At T3, erenumab dosage was increased in 72 patients up to 140 mg, according to the physician's judgment. All patients were allowed to keep their oral preventive medication with a stable dose across all study period.
The primary outcome was to evaluate the role of MIDAS reduction of at least 50% at T3 (MIDASRes) as a predictor of the long-term clinical outcome. As co-primary outcome, the investigators explored the role of early (T3) 50% MMDs reduction (MMDRes) as predictor of long-term efficacy.
In addition, the investigators evaluated the association between MIDASRes as well as MMDRes and the percentage of patients with a reduction in MMDs of at least 50% in the last 4 weeks of observation period (T13) when compared to baseline (RespondersT13). ResponderT13 were defined according to the IHS Guidelines for clinical trials involving CM patients.
As secondary outcomes, the investigators searched for possible associations between baseline clinical/demographic features and long-term efficacy of erenumab treatment, while, as exploratory outcomes, we described 1-year change in migraine-related disability, anxiety and depression severity, allodynia, and quality of life. The study was approved by the local Ethics Committee (P-20190105434).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic migraine with clinical features in agreement with AIFA regulations for CGRP-mAbs prescription.
Key inclusion criteria (4 listed)
- diagnosis of CM according to ICHD-3 criteria for at least 12 months prior to enrollment;
- completion of a full headache diary in the 3 months preceding the enrollment; compliance to complete a daily headache diary for 1 year;
- previous failure of at least 3 classes of preventive treatments among beta-blockers, antiepileptic drugs, antidepressants, or onabotulinumtoxin-A;
- MIDAS score > 11.
Key exclusion criteria (3 listed)
- severe cardiologic comorbidities;
- pregnancy and breastfeeding;
- previous adverse reaction to latex
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erenumab 70/140 mg s.c.Monoclonal antibody directed against the receptor of the Calcitonin Gene Related Peptide (CGRP) | Drug | – |
Primary outcome
Predictive role of early MIDAS score reduction
Time frame: Reduction in MMDs across 1-year treatment period
To evaluate whether a >50% reduction in the MIDAS score at T3 (MIDAS-Res) is predictive of a more pronounced reduction in MMDs during a 1-year erenumab treatment.
Predictive role of early MMDs score reduction
Time frame: Reduction in MMDs across 1-year treatment period
To evaluate whether a >50% reduction in the monthly migraine days (MMDs) at T3 (MMD-Res) is predictive of a more pronounced reduction in MMDs during a 1-year erenumab treatment.
1 secondary outcome
Association between MIDAS-Res or MMD-Res and Responders at the end of the 1-year erenumab treatment
Time frame: MIDAS-Res and MMD-Res defined after three months of erenumab treatment. ResponderT13 defined in the last 4 weeks of the 1-year erenumab treatment.
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 1 Jul 2022.
- Background: PubMed 25164920Hepp Z, Dodick DW, Varon SF, Gillard P, Hansen RN, Devine EB. Adherence to oral migraine-preventive medications among patients with chronic migraine. Cephalalgia. 2015 May;35(6):478-88. doi: 10.1177/0333102414547138. Epub 2014 Aug 27.
- Background: PubMed 29691490Edvinsson L, Haanes KA, Warfvinge K, Krause DN. CGRP as the target of new migraine therapies - successful translation from bench to clinic. Nat Rev Neurol. 2018 Jun;14(6):338-350. doi: 10.1038/s41582-018-0003-1.
- Background: PubMed 31024319Scuteri D, Adornetto A, Rombola L, Naturale MD, Morrone LA, Bagetta G, Tonin P, Corasaniti MT. New Trends in Migraine Pharmacology: Targeting Calcitonin Gene-Related Peptide (CGRP) With Monoclonal Antibodies. Front Pharmacol. 2019 Apr 9;10:363. doi: 10.3389/fphar.2019.00363. eCollection 2019.
- Background: PubMed 28460892Tepper S, Ashina M, Reuter U, Brandes JL, Dolezil D, Silberstein S, Winner P, Leonardi D, Mikol D, Lenz R. Safety and efficacy of erenumab for preventive treatment of chronic migraine: a randomised, double-blind, placebo-controlled phase 2 trial. Lancet Neurol. 2017 Jun;16(6):425-434. doi: 10.1016/S1474-4422(17)30083-2. Epub 2017 Apr 28.
- Background: PubMed 33337544Barbanti P, Aurilia C, Egeo G, Fofi L, Cevoli S, Colombo B, Filippi M, Frediani F, Bono F, Grazzi L, Salerno A, Mercuri B, Carnevale A, Altamura C, Vernieri F. Erenumab in the prevention of high-frequency episodic and chronic migraine: Erenumab in Real Life in Italy (EARLY), the first Italian multicenter, prospective real-life study. Headache. 2021 Feb;61(2):363-372. doi: 10.1111/head.14032. Epub 2020 Dec 18.
- Background: PubMed 35690723Sacco S, Amin FM, Ashina M, Bendtsen L, Deligianni CI, Gil-Gouveia R, Katsarava Z, MaassenVanDenBrink A, Martelletti P, Mitsikostas DD, Ornello R, Reuter U, Sanchez-Del-Rio M, Sinclair AJ, Terwindt G, Uluduz D, Versijpt J, Lampl C. European Headache Federation guideline on the use of monoclonal antibodies targeting the calcitonin gene related peptide pathway for migraine prevention - 2022 update. J Headache Pain. 2022 Jun 11;23(1):67. doi: 10.1186/s10194-022-01431-x.
- Background: PubMed 11098098Stewart WF, Lipton RB, Kolodner KB, Sawyer J, Lee C, Liberman JN. Validity of the Migraine Disability Assessment (MIDAS) score in comparison to a diary-based measure in a population sample of migraine sufferers. Pain. 2000 Oct;88(1):41-52. doi: 10.1016/S0304-3959(00)00305-5.
- Background: PubMed 35146696Iannone LF, Fattori D, Benemei S, Chiarugi A, Geppetti P, De Cesaris F. Long-Term Effectiveness of Three Anti-CGRP Monoclonal Antibodies in Resistant Chronic Migraine Patients Based on the MIDAS score. CNS Drugs. 2022 Feb;36(2):191-202. doi: 10.1007/s40263-021-00893-y. Epub 2022 Feb 11.
- Background: PubMed 30996060Lipton RB, Tepper SJ, Reuter U, Silberstein S, Stewart WF, Nilsen J, Leonardi DK, Desai P, Cheng S, Mikol DD, Lenz R. Erenumab in chronic migraine: Patient-reported outcomes in a randomized double-blind study. Neurology. 2019 May 7;92(19):e2250-e2260. doi: 10.1212/WNL.0000000000007452. Epub 2019 Apr 17.
- Background: PubMed 33400330Ashina M, Goadsby PJ, Reuter U, Silberstein S, Dodick DW, Xue F, Zhang F, Paiva da Silva Lima G, Cheng S, Mikol DD. Long-term efficacy and safety of erenumab in migraine prevention: Results from a 5-year, open-label treatment phase of a randomized clinical trial. Eur J Neurol. 2021 May;28(5):1716-1725. doi: 10.1111/ene.14715. Epub 2021 Jan 20.
- Background: PubMed 33910942Goadsby PJ, Reuter U, Lanteri-Minet M, Paiva da Silva Lima G, Hours-Zesiger P, Fernandes C, Wen S, Tenenbaum N, Kataria A, Ferrari MD, Klatt J. Long-term Efficacy and Safety of Erenumab: Results From 64 Weeks of the LIBERTY Study. Neurology. 2021 May 31;96(22):e2724-e2735. doi: 10.1212/WNL.0000000000012029.
- Background: PubMed 29504482Tassorelli C, Diener HC, Dodick DW, Silberstein SD, Lipton RB, Ashina M, Becker WJ, Ferrari MD, Goadsby PJ, Pozo-Rosich P, Wang SJ; International Headache Society Clinical Trials Standing Committee. Guidelines of the International Headache Society for controlled trials of preventive treatment of chronic migraine in adults. Cephalalgia. 2018 Apr;38(5):815-832. doi: 10.1177/0333102418758283. Epub 2018 Mar 4.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine, run by IRCCS National Neurological Institute "C. Mondino" Foundation at 1 site 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 4 inclusion and 3 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 1 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Predictive role of early MIDAS score reduction (time frame: Reduction in MMDs across 1-year treatment period). 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 NCT05442008, which also lists 36 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 1 Jul 2022; AzTrials last refreshed its copy on 7 Nov 2026.