Evidence map›Paper›PMID 32958075›Full record

Trial reportThe journal of headache and pain2020

The impact of fremanezumab on medication overuse in patients with chronic migraine: subgroup analysis of the HALO CM study.

Stephen D Silberstein, Joshua M Cohen, Michael J Seminerio, Ronghua Yang, Sait Ashina, Zaza Katsarava

2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The journal of headache and pain, 2020. 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 63 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
63citing papers in PubMed, 9 pooled it
11.4field-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.

NCT02621931 phase3completednot on this map

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy and Safety of 2 Dose Regimens of Subcutaneous Administration of Fremanezumab (TEV-48125) Versus Placebo for the Preventive Treatment of Chronic Migraine

TypeinterventionalSponsorTeva Branded Pharmaceutical Products R&D, Inc.Ran2016 to 2017Enrolled1,130ConditionsMigraineArmsFremanezumab, Placebo
NCT07568496 nanot yet recruitingnot on this mapstarted 2026, after this paper: background citation

Greater Occipital Nerve Block for Migraine With Medication Overuse Headache

TypeinterventionalSponsorMahidol UniversityRan2026 to 2028Enrolled130ConditionsMigraine Disorders, Medication Overuse Headache, Greater Occipital Nerve BlockArmsLidocaine 2% and Methylprednisolone 80 mg, Placebo
3 · Its place in the literature

Who cites it

63 citing papers in PubMed, 9 syntheses or guidelines pooled it, 127 citations in OpenAlex.

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  10. Long-term real-world effectiveness and safety of fremanezumab in 1140 patients with migraine and at least 6 months of treatment: third interim analysis of the pan-European PEARL study.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2025
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  13. The first interim analysis of Italian patients enrolled in the real-world, Pan-European, prospective, observational, phase 4 PEARL study of fremanezumab effectiveness.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2024
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  18. Effectiveness of atogepant in migraine with and without medication overuse: Pooled real-world analysis of two independent clinical cohorts.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2026
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3 more citing papers are in PubMed but not listed here.

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 3 countries.

Stephen D SilbersteinJefferson Headache Center, Thomas Jefferson University, 900 Walnut Street, Second Floor, Philadelphia, PA, 19107, USA. Stephen.Silberstein@jefferson.edu.ORCID http://orcid.org/0000-0001-9467-5567
Joshua M CohenTeva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, USA.
Michael J SeminerioTeva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, USA.
Ronghua YangTeva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, USA.
Sait AshinaBIDMC Comprehensive Headache Center, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
Zaza KatsaravaEvangelical Hospital Unna, Unna, Germany.
Teva Pharmaceuticals (United States) · USBeth Israel Deaconess Medical Center · USSechenov University · RUThomas Jefferson University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWe evaluated the efficacy of fremanezumab, a fully humanized monoclonal antibody that selectively targets calcitonin gene-related peptide, in patients with chronic migraine (CM) with and without medication overuse (MO).

methodsIn a 12-week, phase 3 trial, patients with CM were randomized to fremanezumab quarterly (675 mg/placebo/placebo), monthly (675 mg/225 mg/225 mg), or placebo. Post hoc analyses assessed the impact of fremanezumab in patients with and without MO (monthly use of acute headache medication ≥15 days, migraine-specific acute medication ≥10 days, or combination medication ≥10 days) on efficacy outcomes, including headache days of at least moderate severity (HDs), and six-item Headache Impact Test (HIT-6) and Migraine-Specific Quality of Life (MSQoL) questionnaire scores.

resultsOf 1130 patients enrolled, 587 (51.9%) had baseline MO. Fremanezumab reduced placebo-adjusted least-squares mean (95% confidence interval) monthly HDs (- 2.2 [- 3.1 to - 1.2] and - 2.7 [- 3.7 to - 1.8]; P < 0.0001) in patients with MO and without MO (quarterly - 1.4 [- 2.3 to - 0.5], P = 0.0026; monthly - 1.4 [- 2.3 to - 0.6], P = 0.0017). Significantly more fremanezumab-treated patients had ≥ 50% reduction in HDs versus placebo, regardless of baseline MO (with: quarterly 70/201 [34.8%], monthly 78/198 [39.4%] vs placebo 26/188 [13.8%]; without: quarterly 71/174 [40.8%], monthly 75/177 [42.4%] vs placebo 41/183 [22.4%]). Fremanezumab improved HIT-6 and MSQoL scores. Significantly more fremanezumab-treated patients reverted to no MO (quarterly 111/201 [55.2%], monthly 120/198 [60.6%]) versus placebo (87/188 [46.3%]).

conclusionsFremanezumab is effective for prevention of migraine in patients with CM, regardless of MO, and demonstrated a benefit over placebo in reducing MO.

trial registrationClinicalTrials.gov NCT02621931 (HALO CM), registered December 12, 2012.

Indexed as

Migraine DisordersPrescription Drug OveruseAntibodies, MonoclonalDouble-Blind MethodHumansQuality of LifeTreatment OutcomeAntibodies, MonoclonalfremanezumabChronic migraineFremanezumabMedication overuse

Identifiers

PMID32958075
PMCPMC7507645
OpenAlexW3087477661

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.