Trial reportHeadache2022
Tolerability and safety of galcanezumab in patients with chronic cluster headache with up to 15 months of galcanezumab treatment.
Trial report in Headache, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 12 papers, 3 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
12 citing papers in PubMed, 3 syntheses or guidelines pooled it, 26 citations in OpenAlex.
- Efficacy and safety of calcitonin gene-related peptide monoclonal antibodies for cluster headache: a systematic review and frequentist-Bayesian meta-analysis.Journal of neurology · 2026Pooled it
- Safety and efficacy of calcitonin gene-related peptide antagonists for cluster headache: a systematic review and meta-analysis.BMC neurology · 2026Pooled it
- Cluster headache suicidality: a systematic review with a meta-analysis.The journal of headache and pain · 2025Pooled it
- Real-world experience with 240 mg of galcanezumab for the preventive treatment of cluster headache.The journal of headache and pain · 2022Trial
- Tolerability and safety of galcanezumab in patients with chronic cluster headache with up to 15 months of galcanezumab treatment.Headache · 2022Trial
- Identifying cardiac safety signals of disproportionate reporting for CGRP antagonists: evidence from the FDA Adverse Event Reporting System.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Acute Interstitial Nephritis Induced by Monoclonal Antibodies Targeting Calcitonin Gene-Related Peptide (CGRP)-Unveiling a New Association: A Case Report.Kidney medicine · 2025Article
- Managing Cluster Headache in Patients with Medical, Psychiatric, and Surgical Comorbidities.Current neurology and neuroscience reports · 2024Review
- Galcanezumab add-on in refractory cluster headache. A case series.Pain management · 2024Article
- Cardiovascular Adverse Drug Reactions of Anti-Calcitonin Gene-Related Peptide Monoclonal Antibodies for Migraine Prevention: An Analysis from the European Spontaneous Adverse Event Reporting System.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2024Article
- [Galcanezumab for episodic and chronic cluster headache].Schmerz (Berlin, Germany) · 2023Review
- Cluster headache: state of the art in treatment.Frontiers in pain research (Lausanne, Switzerland) · 2023Review
Corrections and comments
- Erratum issuedErratum.2022
Authors and funding
10 authors at 3 institutions in 3 countries.
Funding
Abstract
objectiveThe objective of the study was to assess the tolerability and safety of galcanezumab in patients with chronic cluster headache (CH) with up to 15 months of treatment.
backgroundChronic CH is a highly debilitating disease with a substantial and unmet medical need.
methodsPatients were randomized to receive placebo or galcanezumab (300 mg) monthly for 12 weeks, followed by an optional 52-week open-label extension and 16-week posttreatment follow-up (washout). This is a secondary analysis and long-term follow-up of a previously conducted clinical trial. The safety analysis included patients who received galcanezumab at any time during the study. Outcomes included adverse events (AEs), discontinuations, laboratory values, vital signs, electrocardiograms (ECGs), and suicidality ratings.
resultsA total of 233 patients received at least one galcanezumab dose. The mean exposure was 341 days. Galcanezumab-treated patients were mostly male (n = 169/233; 72.5%) with a mean age of 44.9 (±10.9) years. Treatment-emergent adverse events (TEAEs) were reported by 185 patients (n = 185/233; 79.4%), 23 patients (n = 23/233; 9.9%) reported serious adverse events (SAEs), and 18 patients (n = 18/233; 7.7%) discontinued due to AEs. The SAE CH was reported by three patients. The most common TEAEs (>10%) were nasopharyngitis (n = 41/233; 17.6%) and injection site pain (n = 33/233; 14.2%). 27.5% of patients (n = 64/233) had TEAEs related to injection sites. Likely hypersensitivity events, including injection site rash, injection site urticaria, and injection site hypersensitivity were reported (n = 14/233; 6.0%). There were past histories of suicidal ideation (n = 55/237; 23.2%) and suicidal behavior (n = 9/236; 3.8%). During the study, 15 patients (n = 15/230; 6.5%), seven with previous history, reported suicidal ideation. One patient had a nonfatal suicide attempt during the open-label extension and an aborted attempt during the washout. There were no new safety findings compared with the placebo-controlled treatment period in laboratory values, vital signs, or ECGs.
conclusionsGalcanezumab 300 mg monthly had a favorable tolerability and safety profile in patients with chronic CH with up to 15 months of treatment.
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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.