NCT04803513 (GARLIT) is a clinical trial of Galcanezumab in Migraine, sponsored by Campus Bio-Medico University.

Who is sponsoring NCT04803513?

NCT04803513 is sponsored by Campus Bio-Medico University.

What drugs are being tested in NCT04803513?

Interventions in NCT04803513: Galcanezumab.

Is NCT04803513 still recruiting?

NCT04803513 is currently status unknown. Last updated 17 March 2021.

Last reviewed 2021-03-17 · How we verify

NCT04803513: GARLIT

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Status unknown Last updated 17 March 2021

What this trial tests

trial testing Galcanezumab in Migraine in 300 participants. Status unknown.

Timeline

1 November 2019

Primary endpoint
30 June 2022

31 August 2022

Quick facts

Lead sponsor	Campus Bio-Medico University
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	300
Start date	1 November 2019
Primary completion	30 June 2022
Estimated completion	31 August 2022
Sites	1 location across Italy

Drugs / interventions tested

Galcanezumab (GALCANEZUMAB) — full drug profile →

Conditions studied

Migraine — all drugs for Migraine →

Sponsor

Campus Bio-Medico University

Who can join

18 and older, any sex, with Migraine. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Galcanezumab for the prevention of high frequency episodic and chronic migraine in real life in Italy: a multicenter prospective cohort study (the GARLIT study).
Vernieri F, Altamura C, Brunelli N, Costa CM, et al · · 2021 · cited 95× · PMID 33941080 · DOI 10.1186/s10194-021-01247-1
Discontinuing monoclonal antibodies targeting CGRP pathway after one-year treatment: an observational longitudinal cohort study.
Vernieri F, Brunelli N, Messina R, Costa CM, et al · · 2021 · cited 55× · PMID 34922444 · DOI 10.1186/s10194-021-01363-y
Maintenance of response and predictive factors of 1-year GalcanezumAb treatment in real-life migraine patients in Italy: The multicenter prospective cohort GARLIT study.
Vernieri F, Brunelli N, Marcosano M, Aurilia C, et al · · 2023 · cited 37× · PMID 36097739 · DOI 10.1111/ene.15563
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.
Altamura C, Brunelli N, Marcosano M, Aurilia C, et al · · 2022 · cited 25× · PMID 35763113 · DOI 10.1007/s00415-022-11226-4

Verify or expand the search:

Other trials of Galcanezumab

Trials testing the same drug.

NCT07323927 — Investigator Initiated Trial of Galcanezumab Treatment in Alzheimer's Disease · EARLY_PHASE1 · recruiting
NCT05492695 — Tandem OnabotulinumtoxinA Galcanezumab Emerging Therapeutic Headache Elimination Research Study · Phase 4 · terminated
NCT05281770 — Monoclonal CGRP Antibodies for Migraine Prevention - a Nationwide Real Life Study · unknown
NCT05284019 — Real World Effectiveness of Eptinezumab in Participants With Migraine · Phase 4 · terminated
NCT05127486 — A Study of Galcanezumab (LY2951742) in Adult Participants With Episodic Migraine · Phase 4 · completed

Other recruiting trials for Migraine

Currently open trials in the same condition.

NCT07419607 — MIGRAFIT: Evaluating a Group Therapy Program Combining Physical Activity, Progressive Muscle Relaxation and Psychoeducat · NA · recruiting
NCT07487701 — Migraine Prevention With the Remote Electrical Neuromodulation (REN) Wearable: A Real-world Evidence Study · NA · active not recruiting
NCT07343427 — Impact of GON PRF on Central Sensitization in Migraine Patients · NA · active not recruiting
NCT07336056 — Nerivio Efficacy Under High-Frequency Use · Phase 4 · active not recruiting
NCT07385755 — Desvenlafaxine for Preventive Treatment of Frequent Migraines · NA · active not recruiting

Other Campus Bio-Medico University trials

Trials by the same sponsor.

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NCT06834269 — Transcranial Static Magnetic Stimulation (tSMS) and Potential Theranostic Biomarkers in Amyotrophic Lateral Sclerosis. · NA · recruiting
NCT06098040 — Long-Term Feedback Effect of FGM in Newly-Diagnosed T2D Patients · NA · active not recruiting
NCT05842148 — Quality of Life After Conservative Oncoplastic Surgery in Breast Cancer Patients (IRONY: lIfe afteR ONcoplastic surgerY) · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04803513 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Campus Bio-Medico University
Last refreshed: 17 March 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04803513.

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