Predictive Role of MIDAS Reduction at 3 Months for Erenumab Treatment

Brief summary (from the registry)

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.

Study details

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

Conditions

• Migraine

Interventions

• Drug: Erenumab 70/140 mg s.c.

Sponsor

IRCCS National Neurological Institute "C. Mondino" Foundation

Start date

2018-12-01

Primary completion

2020-01-01

Sex

All

Age range

from 18 Years to 65 Years

Results posted

No results posted in this snapshot

Countries

Italy

Total sites listed

1

Eligibility criteria