ArticleBMC neurology2020
Safety and tolerability of monthly galcanezumab injections in patients with migraine: integrated results from migraine clinical studies.
Article in BMC neurology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 5 registered trials, which are not on this map. Cited by 19 papers.
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.
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Patients With Episodic Migraine
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 in Patients With Episodic Migraine - the EVOLVE-1 Study
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 in Patients With Episodic Migraine - the EVOLVE-2 Study
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 in Patients With Chronic Migraine - the REGAIN Study
A Phase 3, Long-Term, Open-Label Safety Study of LY2951742 in Patients With Migraine
Who cites it
19 citing papers in PubMed, 52 citations in OpenAlex.
- Safety, Tolerability, and Pharmacokinetics of Galcanezumab, an Anti-CGRP Antibody, in Healthy Chinese Participants.Clinical pharmacology in drug development · 2025Trial
- Tolerability and safety of galcanezumab in patients with chronic cluster headache with up to 15 months of galcanezumab treatment.Headache · 2022Trial
- Evaluation of injection-site-related adverse events with galcanezumab: a post hoc analysis of phase 3 studies in participants with migraine.BMC neurology · 2020Trial
- Cognitive Dysfunction in Migraine: Underlying Mechanisms and Clinical Implications.Current pain and headache reports · 2026Review
- Evidence-based review and frontiers of migraine therapy.Neurogastroenterology and motility · 2025Review
- Combining treatments for migraine prophylaxis: the state-of-the-art.The journal of headache and pain · 2024Review
- Quantitative proteomics reveals CLR interactome in primary human cells.The Journal of biological chemistry · 2024Article
- Migraine and Its Treatment from the Medicinal Chemistry Perspective.ACS pharmacology & translational science · 2024Review
- Preventive therapy with galcanezumab for two consecutive cluster bouts in patients with episodic cluster headache: an observational multicenter study.The journal of headache and pain · 2023Observational
- Article
- Eptinezumab for migraine prevention in patients 50 years or older.Acta neurologica Scandinavica · 2022Article
- Patient Perspectives and Experiences of Preventive Treatments and Self-Injectable Devices for Migraine: A Focus Group Study.The patient · 2022Article
- Management of Chronic Migraine in Children and Adolescents: Where are We in 2022?Pediatric health, medicine and therapeutics · 2022Review
- Impact on monthly migraine days of discontinuing anti-CGRP antibodies after one year of treatment - a real-life cohort study.Cephalalgia : an international journal of headache · 2021Article
- Discovery of a First-In-Class Small Molecule Antagonist against the Adrenomedullin-2 Receptor: Structure-Activity Relationships and Optimization.Journal of medicinal chemistry · 2021Article
- The Role of Galcanezumab in Migraine Prevention: Existing Data and Future Directions.Pharmaceuticals (Basel, Switzerland) · 2021Review
- Galcanezumab: A Review in the Prevention of Migraine and Treatment of Episodic Cluster Headache.Drugs · 2020Review
- Correction to: Safety and tolerability of monthly galcanezumab injections in patients with migraine: integrated results from migraine clinical studies.BMC neurology · 2020Article
- Reducing Episodic Cluster Headaches: Focus on Galcanezumab.Journal of pain research · 2020Review
Corrections and comments
- Erratum issued
Authors and funding
8 authors at 4 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundGalcanezumab, a humanized monoclonal antibody that selectively binds to calcitonin gene-related peptide, has demonstrated a significant reduction in monthly migraine headache days in phase 2 and 3 trials. In these analyses, we aimed to evaluate the safety and tolerability of galcanezumab compared with placebo for prevention of episodic or chronic migraine.
methodsData were integrated from three double-blind clinical studies for the up to 6-month galcanezumab exposure group (N = 1435), and from five clinical studies for the up to 1-year all-galcanezumab exposure group (N = 2276). Patients received a monthly 120 mg subcutaneous injection of galcanezumab (with a 240 mg loading dose in month 1), 240 mg galcanezumab, or placebo. Outcomes measured were treatment-emergent adverse events (TEAEs), serious AEs (SAEs), and discontinuation due to AEs (DCAEs). Laboratory results, vital signs, electrocardiogram (ECG), suicidal ideation and behavior results were evaluated.
resultsTEAEs that occurred more frequently in galcanezumab-treated patients included injection site pain, injection site reactions excluding pain, constipation, vertigo, and pruritus. The proportion of DCAEs among galcanezumab-treated patients ranged between 1.8 and 3.0%, and differed from placebo group for galcanezumab 240 mg (P < 0.05). Fewer than 2.0% of patients in either galcanezumab dose-group compared with 1.0% of placebo-treated patients reported a SAE. There were no clinically meaningful differences between galcanezumab and placebo in laboratory measures, vital signs including blood pressure, ECGs, cardiovascular-related AEs, or suicidal ideation and behavior.
conclusionsGalcanezumab demonstrated a favorable safety and tolerability profile for up to 1 year of treatment for the prevention of migraine.
trial registrationClinical Trials CGAB = NCT02163993, EVOLVE-1 = NCT02614183, EVOLVE-2 = NCT02614196, REGAIN = NCT02614261, and CGAJ = NCT02614287. All were first posted on 25 November 2015, except CGAB posted on 16 June 2014, and before enrolling the first patient.
Indexed as
Identifiers
What OpenQuestion holds
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.