Evidence map›Paper›PMID 34874514›Full record

ArticleAdvances in therapy2022

Ubrogepant Is Safe and Efficacious in Participants Taking Concomitant Preventive Medication for Migraine: A Pooled Analysis of Phase 3 Trials.

Andrew M Blumenfeld, Kerry Knievel, Aubrey Manack Adams, Lawrence Severt, Matthew Butler, Hongxin Lai, David W Dodick

3 registry-linked trialsOpen access · hybridAbstract read
In one paragraph

Article in Advances in therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
2.3field-weighted citation impact, top 11% of its field
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.

NCT02828020 phase3completednot on this map

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Single Attack Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine

TypeinterventionalSponsorAllerganRan2016 to 2017Enrolled1,672ConditionsMigraine, With or Without AuraArmsUbrogepant, Placebo-matching Ubrogepant
NCT02867709 phase3completednot on this map

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled Single Attack Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine

TypeinterventionalSponsorAllerganRan2016 to 2018Enrolled1,686ConditionsMigraine, With or Without AuraArmsUbrogepant, Placebo-matching Ubrogepant
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

7 citing papers in PubMed, 15 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Observational
  5. Review
  6. Review
  7. Article
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

7 authors at 4 institutions in 1 country.

Andrew M BlumenfeldHeadache Center of Southern California, 6010 Hidden Valley Rd #200, Carlsbad, CA, 92011, USA. Andrew.Blumenfeld@neurocenter.com.
Kerry KnievelBarrow Neurological Institute, Phoenix, AZ, USA.
Aubrey Manack AdamsAbbVie, Irvine, CA, USA.
Lawrence SevertAbbVie, Madison, NJ, USA.
Matthew ButlerAbbVie, Madison, NJ, USA.
Hongxin LaiAbbVie, Madison, NJ, USA.
David W DodickMayo Clinic, Phoenix, AZ, USA.
AbbVie (United States) · USBarrow Neurological Institute · USMayo Clinic Hospital · USNeurology Center of Southern California · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionUbrogepant is a calcitonin gene-related peptide receptor antagonist indicated for acute treatment of migraine that can be used to treat breakthrough attacks in individuals taking preventive treatment for migraine. We evaluated the impact of preventive medication use on the efficacy and safety of ubrogepant for the acute treatment of migraine.

methodsThis was an analysis of pooled efficacy data from the ACHIEVE I and ACHIEVE II phase 3 trials, in which efficacy of ubrogepant was assessed at 2 h after taking study medication for pain freedom, absence of most bothersome symptom (MBS), and pain relief. In addition, a long-term safety (LTS) extension trial was completed where safety was assessed on the basis of incidence and severity of treatment-emergent adverse events (TEAEs). Outcomes were compared between participants with or without prior (within 6 months) preventive medication use (anticonvulsants, beta blockers, antidepressants, or onabotulinumtoxinA). For efficacy analyses, data were pooled across ACHIEVE trials for the 50 mg and placebo groups; for safety analyses, data for all dose groups (50 mg and 100 mg) in the LTS trial were pooled.

resultsPreventive treatments were used by 417 of 2247 (18.6%) participants analyzed in the ACHIEVE trials and by 143 of 813 (17.5%) participants in the LTS trial. Responder rates for all outcomes were similar between participants with or without preventive treatment within each dose group (p > 0.05). No significant differences were noted across the different preventive medications. Rates and types of TEAEs were similar between participants with or without preventive treatment. No serious treatment-related adverse events were reported.

conclusionEfficacy and safety of ubrogepant for the acute treatment of migraine were similar between participants with or without prior or current use of concomitant preventive medication.

trial registrationClinicalTrials.gov identifiers: NCT02828020 (ACHIEVE I), NCT02867709 (ACHIEVE II), and NCT02873221 (long-term safety trial).

Indexed as

Calcitonin Gene-Related Peptide Receptor AntagonistsMigraine DisordersPyridinesPyrrolesClinical Trials, Phase III as TopicHumansTreatment OutcomeCalcitonin Gene-Related Peptide Receptor AntagonistsPyridinesPyrrolesubrogepantAcute treatmentConcomitant therapiesMigrainePreventive treatmentUbrogepant

Identifiers

PMID34874514
PMCPMC8799553
OpenAlexW4200038234

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.