Predictive Role of MIDAS Reduction at 3 Months for Erenumab Treatment

NCT05442008 | Completed FDA Drug

• 1 other identifier: ERENUMAB2022
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Migraine

Keywords

Migraine; Headache; CGRP; Monoclonal antibodies; Pain; Chronic migraine

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  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.

Interventions

Erenumab 70/140 mg s.c. DRUG

Monoclonal antibody directed against the receptor of the Calcitonin Gene Related Peptide (CGRP)

Eligibility Criteria

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

Study Population

Patients with chronic migraine with clinical features in agreement with AIFA regulations for CGRP-mAbs prescription.

You may qualify if:

• 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.

You may not qualify if:

• severe cardiologic comorbidities;
• pregnancy and breastfeeding;
• previous adverse reaction to latex

Sponsors & Collaborators

• IRCCS National Neurological Institute "C. Mondino" Foundation: lead

Study Sites (1)

Headache Science & Neurorehabilitation Center

Pavia, 27100, Italy

Location

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  PMID: 36115947 DERIVED

MeSH Terms

Conditions

Migraine Disorders; Headache; Pain

Interventions

erenumab

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 1, 2022
• Study Start: December 1, 2018
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2021
• Last Updated: July 1, 2022

Record last verified: 2022-06

Locations

IT (1)