Evidence map›Paper›PMID 35977836›Full record

Trial reportNeurology2022

Efficacy of Ubrogepant in the Acute Treatment of Migraine With Mild Pain vs Moderate or Severe Pain.

Richard B Lipton, David W Dodick, Peter J Goadsby, Rami Burstein, Aubrey M Adams, Jeff Lai, Sung Yun Yu, Michelle Finnegan, Amy W Kuang, Joel M Trugman

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Neurology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02873221 (A Multicenter, Randomized, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine With or Without Aura), which is not on this map. Cited by 13 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

NCT02873221 phase3completednot on this map

A Multicenter, Randomized, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine With or Without Aura

TypeinterventionalSponsorAllerganRan2016 to 2018Enrolled1,254ConditionsMigraine, With or Without AuraArmsUbrogepant, Placebo-matching Ubrogepant, Usual Care
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Guideline
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Observational
  6. Article
  7. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Richard B LiptonFrom the Albert Einstein College of Medicine and Montefiore Headache Center (R.B.L.), Bronx, NY; Mayo Clinic (D.W.D.), Phoenix, AZ; Department of Neurology (P.J.G.), University of California, Los Angeles; NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), King's College, London, United Kingdom; Harvard Medical School (R.B.), Beth Israel Deaconess Medical Center, Boston, MA; AbbVie Inc. (A.M.A., A.W.K.), Irvine, CA; and AbbVie Inc. (J.L., S.Y.Y., M.F., J.M.T.), Madison, NJ. richard.lipton@einsteinmed.org.
David W DodickFrom the Albert Einstein College of Medicine and Montefiore Headache Center (R.B.L.), Bronx, NY; Mayo Clinic (D.W.D.), Phoenix, AZ; Department of Neurology (P.J.G.), University of California, Los Angeles; NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), King's College, London, United Kingdom; Harvard Medical School (R.B.), Beth Israel Deaconess Medical Center, Boston, MA; AbbVie Inc. (A.M.A., A.W.K.), Irvine, CA; and AbbVie Inc. (J.L., S.Y.Y., M.F., J.M.T.), Madison, NJ.
Peter J GoadsbyFrom the Albert Einstein College of Medicine and Montefiore Headache Center (R.B.L.), Bronx, NY; Mayo Clinic (D.W.D.), Phoenix, AZ; Department of Neurology (P.J.G.), University of California, Los Angeles; NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), King's College, London, United Kingdom; Harvard Medical School (R.B.), Beth Israel Deaconess Medical Center, Boston, MA; AbbVie Inc. (A.M.A., A.W.K.), Irvine, CA; and AbbVie Inc. (J.L., S.Y.Y., M.F., J.M.T.), Madison, NJ.
Rami BursteinFrom the Albert Einstein College of Medicine and Montefiore Headache Center (R.B.L.), Bronx, NY; Mayo Clinic (D.W.D.), Phoenix, AZ; Department of Neurology (P.J.G.), University of California, Los Angeles; NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), King's College, London, United Kingdom; Harvard Medical School (R.B.), Beth Israel Deaconess Medical Center, Boston, MA; AbbVie Inc. (A.M.A., A.W.K.), Irvine, CA; and AbbVie Inc. (J.L., S.Y.Y., M.F., J.M.T.), Madison, NJ.
Aubrey M AdamsFrom the Albert Einstein College of Medicine and Montefiore Headache Center (R.B.L.), Bronx, NY; Mayo Clinic (D.W.D.), Phoenix, AZ; Department of Neurology (P.J.G.), University of California, Los Angeles; NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), King's College, London, United Kingdom; Harvard Medical School (R.B.), Beth Israel Deaconess Medical Center, Boston, MA; AbbVie Inc. (A.M.A., A.W.K.), Irvine, CA; and AbbVie Inc. (J.L., S.Y.Y., M.F., J.M.T.), Madison, NJ.
Jeff LaiFrom the Albert Einstein College of Medicine and Montefiore Headache Center (R.B.L.), Bronx, NY; Mayo Clinic (D.W.D.), Phoenix, AZ; Department of Neurology (P.J.G.), University of California, Los Angeles; NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), King's College, London, United Kingdom; Harvard Medical School (R.B.), Beth Israel Deaconess Medical Center, Boston, MA; AbbVie Inc. (A.M.A., A.W.K.), Irvine, CA; and AbbVie Inc. (J.L., S.Y.Y., M.F., J.M.T.), Madison, NJ.
Sung Yun YuFrom the Albert Einstein College of Medicine and Montefiore Headache Center (R.B.L.), Bronx, NY; Mayo Clinic (D.W.D.), Phoenix, AZ; Department of Neurology (P.J.G.), University of California, Los Angeles; NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), King's College, London, United Kingdom; Harvard Medical School (R.B.), Beth Israel Deaconess Medical Center, Boston, MA; AbbVie Inc. (A.M.A., A.W.K.), Irvine, CA; and AbbVie Inc. (J.L., S.Y.Y., M.F., J.M.T.), Madison, NJ.
Michelle FinneganFrom the Albert Einstein College of Medicine and Montefiore Headache Center (R.B.L.), Bronx, NY; Mayo Clinic (D.W.D.), Phoenix, AZ; Department of Neurology (P.J.G.), University of California, Los Angeles; NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), King's College, London, United Kingdom; Harvard Medical School (R.B.), Beth Israel Deaconess Medical Center, Boston, MA; AbbVie Inc. (A.M.A., A.W.K.), Irvine, CA; and AbbVie Inc. (J.L., S.Y.Y., M.F., J.M.T.), Madison, NJ.
Amy W KuangFrom the Albert Einstein College of Medicine and Montefiore Headache Center (R.B.L.), Bronx, NY; Mayo Clinic (D.W.D.), Phoenix, AZ; Department of Neurology (P.J.G.), University of California, Los Angeles; NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), King's College, London, United Kingdom; Harvard Medical School (R.B.), Beth Israel Deaconess Medical Center, Boston, MA; AbbVie Inc. (A.M.A., A.W.K.), Irvine, CA; and AbbVie Inc. (J.L., S.Y.Y., M.F., J.M.T.), Madison, NJ.
Joel M TrugmanFrom the Albert Einstein College of Medicine and Montefiore Headache Center (R.B.L.), Bronx, NY; Mayo Clinic (D.W.D.), Phoenix, AZ; Department of Neurology (P.J.G.), University of California, Los Angeles; NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), King's College, London, United Kingdom; Harvard Medical School (R.B.), Beth Israel Deaconess Medical Center, Boston, MA; AbbVie Inc. (A.M.A., A.W.K.), Irvine, CA; and AbbVie Inc. (J.L., S.Y.Y., M.F., J.M.T.), Madison, NJ.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesTo examine the efficacy of ubrogepant in the treatment of migraine with mild vs moderate or severe pain.

methodsThis was a phase 3, open-label, dose-blinded, 52-week extension trial. Adults with migraine were randomized 1:1:1 (usual care, ubrogepant 50 mg, or ubrogepant 100 mg). Participants treated up to 8 migraine attacks of any pain intensity every 4 weeks. Efficacy outcomes (only collected for ubrogepant) included 2-hour pain freedom (2hPF), freedom from associated symptoms, and from disability. A generalized linear mixed model with binomial distribution and logit link function was used to assess the influence of baseline pain intensity on treatment outcomes in this post hoc analysis.

resultsData for 19,291 attacks from 808 participants were included. 2hPF rates were higher for attacks treated when pain was mild vs moderate or severe: ubrogepant 50 mg (47.1% vs 23.6%; odds ratio [95% CI] 2.89 [2.57-3.24]) and ubrogepant 100 mg (55.2% vs 26.1%; 3.50 [3.12-3.92]; DISCUSSION: Relative to treatment of attacks with moderate or severe pain, treatment with ubrogepant during mild pain resulted in significantly higher rates of freedom from pain, freedom from associated symptoms, and achieving normal function 2 hours after administration. TRIAL REGISTRATION INFORMATION: ClinicalTrials.gov, NCT02873221. CLASSIFICATION OF EVIDENCE: This trial provides Class III evidence that treatment of migraine with ubrogepant when pain is mild vs moderate or severe increases the likelihood of achieving pain freedom, absence of symptoms, and normal function within 2 hours postdose.

Indexed as

Migraine DisordersSumatriptanAdultDouble-Blind MethodHumansPainPyridinesPyrrolesTreatment OutcomePyridinesPyrrolesSumatriptanubrogepant

Identifiers

PMID35977836
PMCPMC9620813

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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.