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Observational Study on the Efficacy, Safety, and Tolerability of GAlcanezumab in Real Life Migraine Patients in ITaly

NCT04803513 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2021-03-17

No results posted yet for this study

Summary

Objective: To determine in real life the efficacy, safety and tolerability of galcanezumab in the prevention of high-frequency episodic migraine (HFEM) and chronic (CM) migraine.

Design: This prospective observational cohort study was conducted between November 2019 and January 2021.

Participants: Consecutive adult HFEM and CM patients clinically prescribed galcanezumab were enrolled.

Setting: Multicenter study in 13 Italian headache centers.

Exposure: Galcanezumab subcutaneous injection 120 mg monthly with the first loading dose of 240 mg.

Main Outcome(s) and Measure(s): The primary end-point was the change in monthly migraine days (MMDs) in HFEM patients and monthly headache days (MHDs) in CM ones after six months of therapy (V6) compared to baseline. Secondary end-points included variation in Numerical Rating Scale (NRS), monthly painkiller intake (MPI), HIT-6, and MIDAS scores. We assessed 50%, 75%, and 100% responder rates (RR), the conversion rate from CM to episodic migraine (EM), and the Medication Overuse condition to the non-overuser.

Conditions

Interventions

DRUG

Galcanezumab

Galcanezumab according to clinical indication in real life

Sponsors & Collaborators

  • Campus Bio-Medico University

    lead OTHER

Principal Investigators

  • Fabrizio Vernieri, MD · Campus Bio-Medico University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-01
Primary Completion
2022-06-30
Completion
2022-08-31
FDA Drug
Yes

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04803513 on ClinicalTrials.gov