Trial reportCephalalgia : an international journal of headache2019
Safety and tolerability of ubrogepant following intermittent, high-frequency dosing: Randomized, placebo-controlled trial in healthy adults.
Trial report in Cephalalgia : an international journal of headache, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis that pooled it.
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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
17 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Safety and Efficacy of Calcitonin Gene-related Peptide Receptor Antagonists and Selective Serotonin Receptor Agonist in the Management of Migraine: A Systematic Review and Meta-analysis.CNS & neurological disorders drug targets · 2024Pooled it
- A 2-Part, Open-Label, Phase 1 Bioequivalence and Food-Effect Study of Ubrogepant in Healthy Adult Participants.Clinical pharmacology in drug development · 2025Trial
- Ubrogepant Is Not Associated With Clinically Meaningful Elevations of Alanine Aminotransferase in Healthy Adult Males.Clinical and translational science · 2020Trial
- Long-Term Safety Evaluation of Ubrogepant for the Acute Treatment of Migraine: Phase 3, Randomized, 52-Week Extension Trial.Headache · 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
- Headaches attributed to cranial and cervical artery dissections.The journal of headache and pain · 2025Review
- [New therapeutic era for migraine attacks with recently approved monoclonal antibodies, ditans and gepants].Revista de neurologia · 2024Review
- Update of Gepants in the Treatment of Chronic Migraine.Current pain and headache reports · 2023Review
- Drug Safety in Episodic Migraine Management in Adults Part 1: Acute Treatments.Current pain and headache reports · 2022Review
- New Generation Gepants: Migraine Acute and Preventive Medications.Journal of clinical medicine · 2022Review
- Ubrogepant to Treat Acute Migraine in Adults.Neurology international · 2021Review
- Safety and Risk of Medication Overuse Headache in Lasmiditan and Second-Generation Gepants: A Rapid Review.Drug, healthcare and patient safety · 2021Review
- Review
- Mechanistic Investigations Support Liver Safety of Ubrogepant.Toxicological sciences : an official journal of the Society of Toxicology · 2020Article
- Ubrogepant: First Approval.Drugs · 2020Review
- Calcitonin gene-related peptide (CGRP): role in migraine pathophysiology and therapeutic targeting.Expert opinion on therapeutic targets · 2020Review
- Article
Corrections and comments
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Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundUbrogepant is a novel, oral calcitonin gene-related peptide (CGRP) receptor antagonist in development for the acute treatment of migraine. This trial evaluated the safety and tolerability of ubrogepant, focusing on hepatic safety, when administered intermittently with high-frequency dosing to healthy participants.
methodsIn this phase 1, multicenter, double-blind, parallel-group trial, healthy adults (age 18-50 years) were randomized 1:1 to placebo or ubrogepant. Ubrogepant was dosed at 100 mg (2 × 50 mg tablets) on 2 consecutive days followed by 2 consecutive days of placebo, alternating for 8 weeks. Primary outcome measures were safety and tolerability.
resultsOf participants randomized (n = 518), 516 were included in the safety population (n = 260 placebo; n = 256 ubrogepant). Treatment-emergent adverse events were reported in 45% of placebo and 44% of ubrogepant participants. The most common was headache (10% placebo; 11% ubrogepant). Overall, seven cases of alanine aminotransferase and/or aspartate aminotransferase levels ≥ 3 × the upper limit of normal (five placebo, two ubrogepant) were reported and adjudicated by a panel of independent liver experts blinded to treatment. Four cases were judged unlikely related to treatment. Two cases (one placebo, one ubrogepant) were judged possibly related, and one (ubrogepant) probably related. Alanine aminotransferase increases to ≥ 3 × the upper limit of normal in the two ubrogepant cases (possibly or probably related) were transient and resolved with continued dosing; both cases were asymptomatic, with no concurrent bilirubin elevation.
conclusionUbrogepant was well tolerated following intermittent, high-frequency dosing in healthy participants, with no clinically relevant signal of hepatotoxicity.
trial registrationNA.
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