Evidence map›Paper›PMID 27281531›Full record

Trial reportNeurology2016

TEV-48125 for the preventive treatment of chronic migraine: Efficacy at early time points.

Marcelo E Bigal, David W Dodick, Abouch V Krymchantowski, Juliana H VanderPluym, Stewart J Tepper, Ernesto Aycardi, Pippa S Loupe, Yuju Ma, Peter J Goadsby

Abstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Neurology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 38 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed, 7 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.

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

38 citing papers in PubMed, 7 syntheses or guidelines pooled it.

  1. Pooled it
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  5. Pooled it
  6. Guideline
  7. The efficacy and safety of calcitonin gene-related peptide monoclonal antibody for episodic migraine: a meta-analysis.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2018
    Pooled it
  8. Trial
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  15. Article
  16. Efficacy and Safety of Anti-CGRP Monoclonal Antibodies in Prevention of Chronic Migraine: A Bayesian Network Meta-analysis.Clinical psychopharmacology and neuroscience : the official scientific journal of the Korean College of Neuropsychopharmacology · 2024
    Review
  17. 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

9 authors.

Marcelo E BigalFrom Teva Pharmaceuticals (M.E.B., E.A., P.S.L., Y.M.); Mayo Clinic (D.W.D., J.H.V.P.), Phoenix, AZ; The Headache Center of Rio (A.V.K.); American Headache Society (A.V.K.); Dartmouth Medical School (S.J.T.), Hanover, NH; and NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), King's College London, UK. marcelo.bigal@tevapharm.com.
David W DodickFrom Teva Pharmaceuticals (M.E.B., E.A., P.S.L., Y.M.); Mayo Clinic (D.W.D., J.H.V.P.), Phoenix, AZ; The Headache Center of Rio (A.V.K.); American Headache Society (A.V.K.); Dartmouth Medical School (S.J.T.), Hanover, NH; and NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), King's College London, UK.
Abouch V KrymchantowskiFrom Teva Pharmaceuticals (M.E.B., E.A., P.S.L., Y.M.); Mayo Clinic (D.W.D., J.H.V.P.), Phoenix, AZ; The Headache Center of Rio (A.V.K.); American Headache Society (A.V.K.); Dartmouth Medical School (S.J.T.), Hanover, NH; and NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), King's College London, UK.
Juliana H VanderPluymFrom Teva Pharmaceuticals (M.E.B., E.A., P.S.L., Y.M.); Mayo Clinic (D.W.D., J.H.V.P.), Phoenix, AZ; The Headache Center of Rio (A.V.K.); American Headache Society (A.V.K.); Dartmouth Medical School (S.J.T.), Hanover, NH; and NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), King's College London, UK.
Stewart J TepperFrom Teva Pharmaceuticals (M.E.B., E.A., P.S.L., Y.M.); Mayo Clinic (D.W.D., J.H.V.P.), Phoenix, AZ; The Headache Center of Rio (A.V.K.); American Headache Society (A.V.K.); Dartmouth Medical School (S.J.T.), Hanover, NH; and NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), King's College London, UK.
Ernesto AycardiFrom Teva Pharmaceuticals (M.E.B., E.A., P.S.L., Y.M.); Mayo Clinic (D.W.D., J.H.V.P.), Phoenix, AZ; The Headache Center of Rio (A.V.K.); American Headache Society (A.V.K.); Dartmouth Medical School (S.J.T.), Hanover, NH; and NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), King's College London, UK.
Pippa S LoupeFrom Teva Pharmaceuticals (M.E.B., E.A., P.S.L., Y.M.); Mayo Clinic (D.W.D., J.H.V.P.), Phoenix, AZ; The Headache Center of Rio (A.V.K.); American Headache Society (A.V.K.); Dartmouth Medical School (S.J.T.), Hanover, NH; and NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), King's College London, UK.
Yuju MaFrom Teva Pharmaceuticals (M.E.B., E.A., P.S.L., Y.M.); Mayo Clinic (D.W.D., J.H.V.P.), Phoenix, AZ; The Headache Center of Rio (A.V.K.); American Headache Society (A.V.K.); Dartmouth Medical School (S.J.T.), Hanover, NH; and NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), King's College London, UK.
Peter J GoadsbyFrom Teva Pharmaceuticals (M.E.B., E.A., P.S.L., Y.M.); Mayo Clinic (D.W.D., J.H.V.P.), Phoenix, AZ; The Headache Center of Rio (A.V.K.); American Headache Society (A.V.K.); Dartmouth Medical School (S.J.T.), Hanover, NH; and NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), King's College London, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the onset of efficacy of TEV-48125, a monoclonal antibody against calcitonin gene-related peptide, recently shown to be effective for the preventive treatment of chronic migraine (CM) and high-frequency episodic migraine.

methodsA randomized placebo-controlled study tested once-monthly injections of TEV-48125 675/225 mg or 900 mg vs placebo. Headache information was captured daily using an electronic headache diary. The primary endpoint was change from baseline in the number of headache hours in month 3. Herein, we assess the efficacy of each dose at earlier time points.

resultsThe sample consisted of 261 patients. For headache hours, the 675/225-mg dose separated from placebo on day 7 and the 900-mg dose separated from placebo after 3 days of therapy (p = 0.048 and p = 0.033, respectively). For both the 675/225-mg and 900-mg doses, the improvement was sustained through the second (p = 0.004 and p < 0.001) and third (p = 0.025 and p < 0.001) weeks of therapy and throughout the study (month 3, p = 0.0386 and p = 0.0057). For change in weekly headache days of at least moderate intensity, both doses were superior to placebo at week 2 (p = 0.031 and p = 0.005).

conclusionsTEV-48125 demonstrated a significant improvement within 1 week of therapy initiation in patients with CM. CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that for patients with CM, TEV-48125 significantly decreases the number of headache hours within 3 to 7 days of injection.

Indexed as

AdultAntibodies, MonoclonalCalcitonin Gene-Related PeptideCentral Nervous System AgentsDose-Response Relationship, DrugDouble-Blind MethodFemaleHumansImmunologic FactorsInjectionsMaleMedical RecordsMiddle AgedMigraine DisordersSeverity of Illness IndexTreatment OutcomeAntibodies, MonoclonalCalcitonin Gene-Related PeptideCentral Nervous System AgentsfremanezumabImmunologic Factors

Identifiers

PMID27281531
PMCPMC4932236

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Registered trials

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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.