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

NCT04803513 | Unknown FDA Drug

• 2 other identifiers: GARLITIRB Number
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Migraine

Outcome Measures

Primary Outcomes (1)

• e change in monthly migraine days (MMDs) on galcanezumab therapy compared to baseline

  MMDs defined as monthly migraine days collected by headache diary

  baseline, monthly and through therapy cycle completion which is an average of 1 year. and after three months after therapy withdrawal.

Secondary Outcomes (1)

• variation in Numerical Rating Scale (NRS), monthly painkiller intake (MPI) during galcanezumab therapy compared to baseline

  baseline, monthly and through therapy cycle completion, which is an average of 1 year, and after three months after therapy withdrawal.

Interventions

Galcanezumab DRUG

Galcanezumab according to clinical indication in real life

Eligibility Criteria

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

Study Population

All consecutive patients aged 18 or older with a diagnosis of high-frequency episodic migraine (8-14 migraine days per month) or chronic migraine (1.3 ICHD-3),

You may qualify if:

• the clinical indication for Galcanezumab as a preventive treatment for Migraine according to European Medicines Agency
• age18 years or older
• or more mean Monthly Migraine Headache days in the last three months

You may not qualify if:

• \- previous exposure to any monoclonal antibodies inhibiting CGRP pathway, including clinical trials

Sponsors & Collaborators

• Campus Bio-Medico University: lead

Study Sites (1)

Campus Bio Medico University Hospital

Rome, RM, 00122, Italy

RECRUITING

Related Publications (3)

• Altamura C, Brunelli N, Marcosano M, Aurilia C, Egeo G, Lovati C, Favoni V, Perrotta A, Maestrini I, Schiano Di Cola F, d'Onofrio F, Finocchi C, Bertuzzo D, Bono F, Ranieri A, Albanese M, Messina R, Doretti A, Di Piero V, Cevoli S, Barbanti P, Vernieri F; GARLIT Study Group. Conversion from chronic to episodic migraine in patients treated with galcanezumab in real life in Italy: the 12-month observational, longitudinal, cohort multicenter GARLIT experience. J Neurol. 2022 Nov;269(11):5848-5857. doi: 10.1007/s00415-022-11226-4. Epub 2022 Jun 28.

  PMID: 35763113 DERIVED

• Vernieri F, Altamura C, Brunelli N, Costa CM, Aurilia C, Egeo G, Fofi L, Favoni V, Lovati C, Bertuzzo D, d'Onofrio F, Doretti A, Di Fiore P, Finocchi C, Schiano Di Cola F, Ranieri A, Colombo B, Bono F, Albanese M, Cevoli S, Barbanti P; GARLIT Study Group. Rapid response to galcanezumab and predictive factors in chronic migraine patients: A 3-month observational, longitudinal, cohort, multicenter, Italian real-life study. Eur J Neurol. 2022 Apr;29(4):1198-1208. doi: 10.1111/ene.15197. Epub 2021 Dec 6.

  PMID: 34826192 DERIVED

• Vernieri F, Altamura C, Brunelli N, Costa CM, Aurilia C, Egeo G, Fofi L, Favoni V, Pierangeli G, Lovati C, Aguggia M, d'Onofrio F, Doretti A, Di Fiore P, Finocchi C, Rao R, Bono F, Ranieri A, Albanese M, Cevoli S, Barbanti P; GARLIT Study Group. Galcanezumab for the prevention of high frequency episodic and chronic migraine in real life in Italy: a multicenter prospective cohort study (the GARLIT study). J Headache Pain. 2021 May 3;22(1):35. doi: 10.1186/s10194-021-01247-1.

  PMID: 33941080 DERIVED

MeSH Terms

Conditions

Migraine Disorders

Interventions

galcanezumab

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Fabrizio Vernieri, MD

  Campus Bio-Medico University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabrizio Vernieri, MD

CONTACT

003922541; f.vernieri@unicampus.it

Claudia Altamura, MD PhD

CONTACT

003962251; c.altamura@unicampus.it

Study Design

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

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: March 17, 2021
• Study Start: November 1, 2019
• Primary Completion: June 30, 2022
• Study Completion: August 31, 2022
• Last Updated: March 17, 2021

Record last verified: 2021-03

Locations

IT (1)