Trial reportHeadache2020
Long-Term Safety Evaluation of Ubrogepant for the Acute Treatment of Migraine: Phase 3, Randomized, 52-Week Extension Trial.
Trial report in Headache, 2020. 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 45 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
45 citing papers in PubMed, 102 citations in OpenAlex.
- A 52-week open-label extension study to evaluate the safety and efficacy of oral rimegepant for the preventive treatment of migraine.Headache · 2026Trial
- Effect of Ubrogepant on Patient-Reported Outcomes When Administered During the Migraine Prodrome: Results From the Randomized PRODROME Trial.Neurology · 2024Trial
- Efficacy of Ubrogepant in the Acute Treatment of Migraine With Mild Pain vs Moderate or Severe Pain.Neurology · 2022Trial
- Time course of efficacy of ubrogepant for the acute treatment of migraine: Clinical implications.Cephalalgia : an international journal of headache · 2021Trial
- Ubrogepant Is Not Associated With Clinically Meaningful Elevations of Alanine Aminotransferase in Healthy Adult Males.Clinical and translational science · 2020Trial
- Safety and tolerability of ubrogepant following intermittent, high-frequency dosing: Randomized, placebo-controlled trial in healthy adults.Cephalalgia : an international journal of headache · 2019Trial
- Geriatric Migraine, Geroscience, and Sustainable Development Goals: Bridging Clinical Complexity and Public Health Priorities.Journal of clinical medicine · 2026Review
- Review
- A Human Mass Balance and Metabolism Study of [Clinical pharmacology in drug development · 2026Article
- Migraine Management in Japan: Current Approaches and Science Narrative Including an Evidence-based Review.Internal medicine (Tokyo, Japan) · 2026Review
- Gepants: Key Features of A Potent Therapeutic Option and Considerations in The Latin American Context.Revista de neurologia · 2025Review
- Evidence-based review and frontiers of migraine therapy.Neurogastroenterology and motility · 2025Review
- Headaches attributed to cranial and cervical artery dissections.The journal of headache and pain · 2025Review
- Neurite Damage in Patients with Migraine.Neurology international · 2024Article
- Real-World Use of Ubrogepant as Acute Treatment for Migraine with an Anti-Calcitonin Gene-Related Peptide Monoclonal Antibody: Results from COURAGE.Neurology and therapy · 2024Article
- [New therapeutic era for migraine attacks with recently approved monoclonal antibodies, ditans and gepants].Revista de neurologia · 2024Review
- Bridging the Mind and Gut: Uncovering the Intricacies of Neurotransmitters, Neuropeptides, and their Influence on Neuropsychiatric Disorders.Central nervous system agents in medicinal chemistry · 2024Review
- Review
- Real-world effectiveness, satisfaction, and optimization of ubrogepant for the acute treatment of migraine in combination with onabotulinumtoxinA: results from the COURAGE Study.The journal of headache and pain · 2023Observational
- Molecular Mechanisms of Migraine: Nitric Oxide Synthase and Neuropeptides.International journal of molecular sciences · 2023Review
Corrections and comments
- Erratum issuedErratum.2021
Authors and funding
10 authors at 4 institutions in 1 country.
Funding
Abstract
objectiveTo evaluate the long-term safety and tolerability of ubrogepant for the acute treatment of migraine.
backgroundUbrogepant is an oral, calcitonin gene-related receptor antagonist in development for the acute treatment of migraine. The efficacy of ubrogepant was demonstrated in 2 phase 3 trials in which a significant improvement was observed in migraine headache pain, migraine-associated symptoms, and ability to function.
methodsThis was a phase 3, multicenter, randomized, open-label, 52-week extension trial. Adults with migraine with or without aura entered the trial after completing one of 2 phase 3 lead-in trials and were re-randomized 1:1:1 to usual care, ubrogepant 50 mg, or ubrogepant 100 mg. Randomization to ubrogepant dose was blinded. Those randomized to usual care continued to treat migraine attacks with their own medication. The usual care arm was included in this trial to capture background rates of hepatic laboratory parameters and contextualize hepatic safety assessments. Safety and tolerability were the primary outcome measures. The safety population for the ubrogepant arms included all randomized participants who received at least 1 dose of treatment. All cases of alanine aminotransferase (ALT)/aspartate aminotransferase (AST) elevations of ≥3 times the upper limit of normal were adjudicated by an independent panel of liver experts who were blinded to dose.
resultsThe safety population included 1230 participants (404 in the ubrogepant 50-mg group, 409 in the ubrogepant 100-mg group, and 417 in the usual care group). Participants were on average 42 years of age, 90% (1106/1230) female and 85% (1043/1230) white, with an average BMI of 30 kg/m
conclusionsLong-term intermittent use of ubrogepant 50 and 100 mg given as 1 or 2 doses per attack for the acute treatment of migraine was safe and well tolerated, as indicated by a low incidence of treatment-related TEAEs and SAEs and discontinuations due to adverse events in this 1-year trial.
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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.