Evidence map›Paper›PMID 30120138›Full record

ArticleNeurology2018

Fremanezumab for preventive treatment of migraine: Functional status on headache-free days.

Juliana VanderPluym, David W Dodick, Richard B Lipton, Yuju Ma, Pippa S Loupe, Marcelo E Bigal

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

Article in Neurology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
5.4field-weighted citation impact, top 3% 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.

NCT02021773 phase2completednot on this map

A Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel Group, Multi-dose Study Comparing the Efficacy and Safety of Subcutaneous LBR-101 With Placebo for the Preventive Treatment of Chronic Migraine

TypeinterventionalSponsorTeva Branded Pharmaceutical Products R&D, Inc.Ran2014 to 2015Enrolled264ConditionsChronic MigraineArmsLBR-101 High Dose, LBR-101 Low Dose, Placebo
NCT02025556 phase2completednot on this map

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Study Comparing the Efficacy and Safety of Two Doses of Subcutaneous LBR-101 With Placebo for the Preventive Treatment of High Frequency Episodic Migraine

TypeinterventionalSponsorTeva Branded Pharmaceutical Products R&D, Inc.Ran2014 to 2015Enrolled297ConditionsEpisodic Migraine HeadacheArmsLBR-101 High Dose, LBR-101 Low Dose, Placebo
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 1 synthesis or guideline pooled it, 46 citations in OpenAlex.

  1. Guideline
  2. Trial
  3. Trial
  4. Article
  5. Review
  6. Molecular Mechanisms of Migraine: Nitric Oxide Synthase and Neuropeptides.International journal of molecular sciences · 2023
    Review
  7. Review
  8. Review
  9. Article
  10. Review
  11. Article
  12. Review
  13. Dural Calcitonin Gene-Related Peptide Produces Female-Specific Responses in Rodent Migraine Models.The Journal of neuroscience : the official journal of the Society for Neuroscience · 2019
    Article
  14. Review
  15. 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

6 authors at 4 institutions in 2 countries.

Juliana VanderPluymFrom the Mayo Clinic (J.V., D.W.D.), Phoenix, AZ; Montefiore Headache Center (R.B.L.), Albert Einstein College of Medicine, New York, NY; Teva Pharmaceuticals Ltd (Y.M., P.S.L.), Netanya, Israel; and Teva Pharmaceuticals Ltd (M.E.B.), Frazer, PA. Dr. Bigal is now at Purdue Pharma, Stamford, CT. VanderPluym.Juliana@mayo.edu.
David W DodickFrom the Mayo Clinic (J.V., D.W.D.), Phoenix, AZ; Montefiore Headache Center (R.B.L.), Albert Einstein College of Medicine, New York, NY; Teva Pharmaceuticals Ltd (Y.M., P.S.L.), Netanya, Israel; and Teva Pharmaceuticals Ltd (M.E.B.), Frazer, PA. Dr. Bigal is now at Purdue Pharma, Stamford, CT.
Richard B LiptonFrom the Mayo Clinic (J.V., D.W.D.), Phoenix, AZ; Montefiore Headache Center (R.B.L.), Albert Einstein College of Medicine, New York, NY; Teva Pharmaceuticals Ltd (Y.M., P.S.L.), Netanya, Israel; and Teva Pharmaceuticals Ltd (M.E.B.), Frazer, PA. Dr. Bigal is now at Purdue Pharma, Stamford, CT.
Yuju MaFrom the Mayo Clinic (J.V., D.W.D.), Phoenix, AZ; Montefiore Headache Center (R.B.L.), Albert Einstein College of Medicine, New York, NY; Teva Pharmaceuticals Ltd (Y.M., P.S.L.), Netanya, Israel; and Teva Pharmaceuticals Ltd (M.E.B.), Frazer, PA. Dr. Bigal is now at Purdue Pharma, Stamford, CT.
Pippa S LoupeFrom the Mayo Clinic (J.V., D.W.D.), Phoenix, AZ; Montefiore Headache Center (R.B.L.), Albert Einstein College of Medicine, New York, NY; Teva Pharmaceuticals Ltd (Y.M., P.S.L.), Netanya, Israel; and Teva Pharmaceuticals Ltd (M.E.B.), Frazer, PA. Dr. Bigal is now at Purdue Pharma, Stamford, CT.
Marcelo E BigalFrom the Mayo Clinic (J.V., D.W.D.), Phoenix, AZ; Montefiore Headache Center (R.B.L.), Albert Einstein College of Medicine, New York, NY; Teva Pharmaceuticals Ltd (Y.M., P.S.L.), Netanya, Israel; and Teva Pharmaceuticals Ltd (M.E.B.), Frazer, PA. Dr. Bigal is now at Purdue Pharma, Stamford, CT.
Albert Einstein College of Medicine · USWinnMed · USMayo Clinic in Florida · USTeva Pharmaceuticals (Israel) · IL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the effect of fremanezumab on the functional status on headache-free days in phase 2 episodic migraine (EM) and chronic migraine (CM) studies.

methodsFunctional status data were collected prospectively via the electronic headache diary on all headache-free days by patients answering questions regarding work/school/household chore performance, speed of work completion, concentration, and feeling of fatigue. Individuals with EM receiving monthly doses of fremanezumab 225 mg (n = 96) or 675 mg (n = 97) or placebo (n = 104) were compared. Individuals with CM receiving fremanezumab 675 mg followed by monthly 225 mg (n = 88) and 900 mg (n = 86) were also independently compared to those receiving placebo (n = 89).

resultsIn patients with EM, compared to patients receiving placebo, those receiving fremanezumab experienced an increased number of headache-free days with normal function in work/school/household chore performance and concentration/mental fatigue measures compared to their baseline over the entire treatment period (all

conclusionThere was an increased number of headache-free days with normal functional performance on all measures for the patients with EM and some measures for patients with CM in the fremanezumab-treated groups. Further research is required to confirm these findings in a prospective study and to clarify the underlying mechanism(s). CLINICALTRIALSGOV IDENTIFIER: NCT02025556 and NCT02021773. CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that for patients with migraine, fremanezumab increases normal functional performance on headache-free days.

Indexed as

Academic PerformancePhysical Functional PerformanceWork PerformanceAdolescentAdultAgedAntibodies, MonoclonalClinical Trials, Phase II as TopicDrug Administration ScheduleFatigueFemaleHumansMaleMedical RecordsMiddle AgedMigraine DisordersAntibodies, Monoclonalfremanezumab

Identifiers

PMID30120138
PMCPMC6161555
OpenAlexW2885529412

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.