Evidence map›Paper›PMID 33818780›Full record

Trial reportHeadache2021

Pharmacokinetics and safety of ubrogepant when coadministered with calcitonin gene-related peptide-targeted monoclonal antibody migraine preventives in participants with migraine: A randomized phase 1b drug-drug interaction study.

Abhijeet Jakate, Andrew M Blumenfeld, Ramesh Boinpally, Matthew Butler, Lisa Borbridge, Janette Contreras-De Lama, Danielle McGeeney, Antonia Periclou, Richard B Lipton

Open access · hybridAbstract readClinical Trial, Phase IMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Headache, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 37 papers.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed
8.7field-weighted citation impact, top 1% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

37 citing papers in PubMed, 66 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. Review
  6. Review
  7. Review
  8. Article
  9. Review
  10. Review
  11. Review
  12. Update on gepants for the treatment of chronic migraine.Journal of the Chinese Medical Association : JCMA · 2024
    Review
  13. Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. A Brief Review of Gepants.Current pain and headache reports · 2023
    Review
  20. Review
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

9 authors at 3 institutions in 1 country.

Abhijeet JakateClinical Pharmacology, AbbVie, Madison, NJ, USA.
Andrew M BlumenfeldHeadache Center of Southern California, Carlsbad, CA, USA.
Ramesh BoinpallyClinical Pharmacology, AbbVie, Madison, NJ, USA.
Matthew ButlerClinical Pharmacology, AbbVie, Madison, NJ, USA.
Lisa BorbridgeBioanalysis, Non-clinical and Translational Sciences, AbbVie, Irvine, CA, USA.
Janette Contreras-De LamaClinical Pharmacology, AbbVie, Madison, NJ, USA.
Danielle McGeeneyClinical Pharmacology, AbbVie, Madison, NJ, USA.
Antonia PericlouClinical Pharmacology, AbbVie, Madison, NJ, USA.
Richard B LiptonThe Saul R. Korey Department of Neurology, Department of Psychiatry and Behaviorial Sciences, Department of Epidemiology & Population Health, Albert Einstein College of Medicine, Bronx, NY, USA.
AbbVie (United States) · USAlbert Einstein College of Medicine · USNeurology Center of Southern California · US

Funding

AbbVie
6 · The paper itself

Abstract

objectiveTo evaluate the impact of two calcitonin gene-related peptide (CGRP)-targeted monoclonal antibodies (mAbs), erenumab and galcanezumab, on the pharmacokinetic (PK) profile, safety, and tolerability of ubrogepant.

backgroundPeople taking CGRP-targeted mAbs for migraine prevention sometimes take ubrogepant, an oral small-molecule CGRP receptor antagonist, for acute treatment of breakthrough migraine attacks.

designIn this two-arm, multicenter, open-label, phase 1b trial, adults with migraine were randomized to arm 1 (ubrogepant ± erenumab) or arm 2 (ubrogepant ± galcanezumab). The PK profile of ubrogepant was characterized for administration before and 4 days after CGRP-targeted mAb injection. Participants received single-dose ubrogepant 100 mg on day 1, subcutaneous erenumab 140 mg (arm 1) or galcanezumab 240 mg (arm 2) on day 8, and ubrogepant 100 mg once daily on days 12-15. In each study arm, serial blood samples were drawn on days 1 and 12 for measurement of plasma ubrogepant concentrations. The primary outcomes were area under the plasma ubrogepant concentration-time curve (AUC) from time 0 to t post-dose (AUC

resultsForty participants enrolled (20 per arm; mean [standard deviation] ages, 32.2 [8.9] and 38.4 [8.8] years; 50% [10/20] and 60% [12/20] female in arms 1 and 2, respectively). There were no significant differences in ubrogepant C

conclusionsThe PK profile of ubrogepant was not significantly changed and no safety concerns were identified when ubrogepant was coadministered with erenumab or galcanezumab.

Indexed as

AdultAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedCalcitonin Gene-Related PeptideDrug InteractionsDrug Therapy, CombinationFemaleHumansMaleMiddle AgedMigraine DisordersPyridinesPyrrolesAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedCalcitonin Gene-Related PeptideerenumabgalcanezumabPyridinesPyrrolesubrogepantcalcitonin gene-related peptideCGRPerenumabgalcanezumabheadacheubrogepant

Identifiers

PMID33818780
PMCPMC8252052
OpenAlexW3144543283

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.