Observational studyThe journal of headache and pain2021
Galcanezumab for the prevention of high frequency episodic and chronic migraine in real life in Italy: a multicenter prospective cohort study (the GARLIT study).
Observational study in The journal of headache and pain, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 68 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Observational Study on the Efficacy, Safety, and Tolerability of GAlcanezumab in Real Life Migraine Patients in ITaly (GARLIT)
Study of Early MIDAS Reduction at 3 Months as Predictor of Long-term Erenumab Treatment in Chronic Migraine: a Real-life, Open-label, Trial
Anti-Calcitonin Gene-Related Peptide (CGRP) Monoclonal Antibody Response After Switching in the Treatment of Migraine
Who cites it
68 citing papers in PubMed, 4 syntheses or guidelines pooled it, 147 citations in OpenAlex.
- Real-world effectiveness and safety of galcanezumab for the treatment of migraine: A systematic review and meta-analysis.Headache · 2026Pooled it
- Real-world experience of galcanezumab in the prevention of migraine in Spain: a systematic literature review.Frontiers in neurology · 2024Pooled it
- Methodological considerations on real-world evidence studies of monoclonal antibodies against the CGRP-pathway for migraine: a systematic review.The journal of headache and pain · 2023Pooled it
- Pooled it
- Smartphone-Based Muscle Relaxation for Migraine in the Emergency Department: A Randomized Clinical Trial.JAMA network open · 2025Trial
- Shift from chronic to episodic migraine frequency in a long-term phase 3 study of galcanezumab.The journal of headache and pain · 2025Trial
- Does MIDAS reduction at 3 months predict the outcome of erenumab treatment? A real-world, open-label trial.The journal of headache and pain · 2022Trial
- Galcanezumab in episodic migraine: the phase 3, randomized, double-blind, placebo-controlled PERSIST study.The journal of headache and pain · 2022Trial
- Real-world effectiveness after initiating fremanezumab treatment in US patients with episodic and chronic migraine or difficult-to-treat migraine.The journal of headache and pain · 2022Trial
- Effects of Galcanezumab on Health-Related Quality of Life and Disability in Patients with Previous Failure of 2-4 Migraine Preventive Medication Categories: Results from a Phase IIIb Randomized, Placebo-Controlled, Multicenter Clinical Trial (CONQUER).Clinical drug investigation · 2022Trial
- Article
- Effectiveness of Galcanezumab and Traditional Oral Migraine Preventive Medications: Interim 3-Month Japan Subgroup Findings from the TRIUMPH Study.Advances in therapy · 2026Observational
- Results from TRIUMPH [EUROPE], a Real-World Observational Study on the 3-Month Effectiveness of Galcanezumab Versus Traditional Oral Migraine Preventive Medications.Pain and therapy · 2026Article
- Observational
- Responders and super-responders to atogepant after 24 weeks of treatment in migraine: real-world evidence from the GIANT-2 study.The journal of headache and pain · 2026Observational
- Disrupting Migraine Dynamics: A Narrative Review of the Consequences of Modern Anti-CGRP Monoclonal Antibody Therapies.Neurology and therapy · 2025Review
- A 24-week prospective, multicenter, real-world study on eptinezumab's effectiveness and safety in migraine prevention (EMBRACE II).Journal of neurology · 2025Observational
- Efficacy and continuability of 675 mg fremanezumab administration over 2 years.The journal of headache and pain · 2025Observational
- Real-World Lessons with Fremanezumab as the Third Available CGRP Monoclonal Antibody in a Third-Level Hospital: Focus on the Factors Predicting Response.Journal of clinical medicine · 2025Article
- Blood pressure monitoring in elderly migraineurs starting an anti-CGRP monoclonal antibody: a real-world prospective study.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2024Observational
8 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
22 authors at 12 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe clinical benefit of galcanezumab, demonstrated in randomized clinical trials (RCTs), remains to be quantified in real life. This study aimed at evaluating the effectiveness, safety and tolerability of galcanezumab in the prevention of high-frequency episodic migraine (HFEM) and chronic migraine (CM) in a real-life setting.
methodsThis multicenter prospective observational cohort study was conducted between November 2019 and January 2021 at 13 Italian headache centers. Consecutive adult HFEM and CM patients clinically eligible were enrolled and treated with galcanezumab subcutaneous injection 120 mg monthly with the first loading dose of 240 mg. The primary endpoint was the change in monthly migraine days (MMDs) in HFEM and monthly headache days (MHDs) in CM patients after 6 months of therapy (V6). Secondary endpoints were the Numerical Rating Scale (NRS), monthly painkiller intake (MPI), HIT-6 and MIDAS scores changes, ≥50% responder rates (RR), the conversion rate from CM to episodic migraine (EM) and Medication Overuse (MO) discontinuation.
resultsOne hundred sixty-three patients (80.5% female, 47.1 ± 11.7 years, 79.8% CM) were included. At V6, MMDs reduced by 8 days in HFEM and MHDs by 13 days in CM patients (both p < .001). NRS, MPI, HIT-6 and MIDAS scores significantly decreased (p < .001). Ten patients (6.1%) dropped out for inefficacy and classified as non-responders. Patients with ≥50%RRs, i.e. responders, were 76.5% in the HFEM and 63.5% in the CM group at V6. Among CM patients, the V6 responders presented a lower body mass index (p = .018) and had failed a lower number of preventive treatments (p = .013) than non-responders. At V6, 77.2% of CM patients converted to EM, and 82.0% ceased MO. Adverse events, none serious, were reported in up to 10.3% of patients during evaluation times.
conclusionsGalcanezumab in real life was safe, well tolerated and seemed more effective than in RCTs. Normal weight and a low number of failed preventives were positively associated with galcanezumab effectiveness in CM patients.
trial registrationClinicalTrials.gov NCT04803513 .
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.