Evidence map›Paper›PMID 25500317›Full record

Trial reportJournal of neurology, neurosurgery, and psychiatry2015

Per cent of patients with chronic migraine who responded per onabotulinumtoxinA treatment cycle: PREEMPT.

Stephen D Silberstein, David W Dodick, Sheena K Aurora, Hans-Christoph Diener, Ronald E DeGryse, Richard B Lipton, Catherine C Turkel

3 registry-linked trialsAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of neurology, neurosurgery, and psychiatry, 2015. 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 64 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
64citing papers in PubMed, 3 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.

NCT00156910 phase3completednot on this map

A Study Using Botulinum Toxin Type A as Headache Prophylaxis for Migraine Patients With Frequent Headaches

TypeinterventionalSponsorAllerganRan2006 to 2008Enrolled679ConditionsMigraine DisordersArmsBotulinum Toxin Type A, Placebo (saline)
NCT00168428 phase3completednot on this map

A Study Using Botulinum Toxin Type A as Headache Prophylaxis for Migraine Patients With Frequent Headaches

TypeinterventionalSponsorAllerganRan2006 to 2008Enrolled705ConditionsMigraine DisordersArmsBotulinum Toxin Type A, placebo (saline)
NCT04580238 phase1withdrawnnot on this mapstarted 2023, after this paper: background citation

Onabotulinum Toxin A (Botox) for the Treatment of Persistent Post-Stroke and Vascular Headache

TypeinterventionalSponsorUniversity of AlbertaRan2023 to 2025Enrolled0ConditionsStroke (CVA) or TIA, Headache, Migraine, Botulinum Toxins, Type A, Cerebral Venous Sinus ThrombosisArmsBotox 200 UNT Injection, Non Botox based Standard of Care Treatments for Headache/Migraine
3 · Its place in the literature

Who cites it

64 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Botulinum toxins for the prevention of migraine in adults.The Cochrane database of systematic reviews · 2018
    Pooled it
  4. Trial
  5. Trial
  6. The Use of Botulinum Toxin in the Management of Headache Disorders.Handbook of experimental pharmacology · 2021
    Trial
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Trial
  13. Trial
  14. Review
  15. Review
  16. Article
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  19. Review
  20. Review

4 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

7 authors.

Stephen D SilbersteinDepartment of Neurology, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.
David W DodickDepartment of Neurology, Mayo Clinic Arizona, Phoenix, Arizona, USA.
Sheena K AuroraDepartment of Neurology and Neurological Sciences, Stanford University, Stanford, California, USA.
Hans-Christoph DienerDepartment of Neurology and Stroke Center, University of Essen, Essen, Germany.
Ronald E DeGryseAllergan, Inc., Irvine, California, USA.
Richard B LiptonDepartment of Neurology and the Montefiore Headache Center, Albert Einstein College of Medicine, Bronx, New York, USA.
Catherine C TurkelClinical Development Neurology & Pain, Allergan, Inc., Irvine, California, USA.

Funding

Vascular Structure and Function in Cognitive AgingP01AG003949 · NIA · YESHIVA UNIVERSITY · PI Charles B Hall · 1985 to 2026
$73.9M
PREDICTORS OF COGNITIVE DECLINE IN NORMAL AGINGR01AG012101 · NIA · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI DE LEON, MONY J., RUSINEK, HENRY · 1993 to 2015
$6.7M
Biomarkers in Early Alzheimer's Disease (AD).R01AG022374 · NIA · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI DE LEON, MONY J., RUSINEK, HENRY · 2004 to 2015
$5.2M
TWO PRECLINICAL LATENT SCORES TO PREDICT OCCURRENCE OF DATR01AG034119 · NIA · WASHINGTON UNIVERSITY · PI XIONG, CHENGJIE · 2010 to 2014
$1.6M
Latent Mobility Abnormalities And FrailtyR01AG025119 · NIA · ALBERT EINSTEIN COL OF MED YESHIVA UNIV · PI VERGHESE, JOE · 2005 to 2009
$1.5M
NIA NIH HHS P01 AG003949NIA NIH HHS P01 AG03949NIA NIH HHS R01 AG012101NIA NIH HHS R01 AG022374NIA NIH HHS R01AG022374-06A2NIA NIH HHS R01 AG025119NIA NIH HHS R01AG025119NIA NIH HHS R01 AG034119NIA NIH HHS R01AG034119NIA NIH HHS R01AG12101
6 · The paper itself

Abstract

objectiveThe approved use of onabotulinumtoxinA for prophylaxis of headaches in patients with chronic migraine (CM) involves treatment every 12 weeks. It is currently unknown whether patients who fail to respond to the first onabotulinumtoxinA treatment cycle will respond to subsequent treatment cycles. To help inform decisions about treating non-responders, we examined the probability of treatment cycle 1 non-responders responding in cycle 2, and cycle 1 and 2 non-responders responding in cycle 3.

methodsPooled PREEMPT data (two studies: a 24-week, 2-cycle, double-blind, randomised (1:1), placebo-controlled, parallel-group phase, followed by a 32-week, 3-cycle, open-label phase) evaluated onabotulinumtoxinA (155-195 U) for prophylaxis of headaches in persons with CM (≥15 days/month with headache ≥4 h/day). End points of interest included the proportion of study patients who first achieved a ≥50% reduction in headache days, moderate/severe headache days, total cumulative hours of headache on headache days, or a ≥5-point improvement in Headache Impact Test (HIT)-6. For treatment cycle 1, all eligible participants were included. For subsequent cycles, responders in a previous cycle were no longer considered first responders.

resultsAmong onabotulinumtoxinA-treated patients (n=688) 49.3% had a ≥50% reduction in headache-day frequency during treatment cycle 1, with 11.3% and 10.3% of patients first responding during cycles 2 and 3, respectively. 54.2%, 11.6% and 7.4% of patients first responded with a ≥50% reduction in cumulative hours of headache, and 56.3%, 14.5% and 7.7% of patients first responded with a ≥5-point improvement in total HIT-6 during treatment cycles 1, 2 and 3, respectively.

conclusionsA meaningful proportion of patients with CM treated with onabotulinumtoxinA who did not respond to the first treatment cycle responded in the second and third cycles of treatment. TRIAL REGISTRATION NUMBER: NCT00156910, NCT00168428.

Indexed as

AdultBotulinum Toxins, Type AChronic DiseaseDouble-Blind MethodFemaleHumansMaleMigraine DisordersNeuromuscular AgentsTreatment OutcomeBotulinum Toxins, Type ANeuromuscular AgentsBOTULINUM TOXINHEADACHEMIGRAINE

Identifiers

PMID25500317
PMCPMC4552933

What OpenQuestion holds

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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.