Evidence map›Paper›PMID 20647170›Full record

Trial reportCephalalgia : an international journal of headache2010

OnabotulinumtoxinA for treatment of chronic migraine: results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 1 trial.

S K Aurora, D W Dodick, C C Turkel, R E DeGryse, S D Silberstein, R B Lipton, H C Diener, M F Brin, PREEMPT 1 Chronic Migraine Study Group

3 registry-linked trialsAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Cephalalgia : an international journal of headache, 2010. 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 351 papers, 19 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
351citing papers in PubMed, 19 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.

NCT04578782 phase2completednot on this mapstarted 2018, after this paper: background citation

Pilot Study for the Evaluation of the Efficacy of OnabotulinumtoxinA in High Frequency Migraine

TypeinterventionalSponsorIRCCS National Neurological Institute "C. Mondino" FoundationRan2018 to 2020Enrolled32ConditionsMigraineArmsOnabotulinumtoxinA
NCT05598723 phase3recruitingnot on this mapstarted 2023, after this paper: background citation

A Randomized, Double-Blind Study on the Effect of OnabotulinumtoxinA (BOTOX®) vs. IncobotulinumtoxinA (XEOMIN®) Botulinum Toxin in Adults With Chronic Migraine

TypeinterventionalSponsorNaval Medical Center Camp LejeuneRan2023 to 2027Enrolled128ConditionsChronic MigraineArmsIncobotulinumtoxinA (XEOMIN®), OnabotulinumtoxinA (BOTOX®)
NCT07040813 phase3recruitingnot on this mapstarted 2025, after this paper: background citation

A Randomized Placebo-controlled Double-blind Phase III Trial to Investigate the Reduction of Monthly Migraine Days (MMDs) Over 12 Weeks of Treatment With CGRP mAbs and Onabotulinumtoxin A Intramuscularly Compared With CGRP mAbs and Placebo in Chronic Migraine

TypeinterventionalSponsorOslo University HospitalRan2025 to 2029Enrolled450ConditionsMigraine, Chronic Migraine HeadacheArmsCGRP mAbs and onabotulinumtoxin A, CGRP mAbs and placebo
3 · Its place in the literature

Who cites it

351 citing papers in PubMed, 19 syntheses or guidelines pooled it.

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  18. Guideline
  19. Botulinum toxins for the prevention of migraine in adults.The Cochrane database of systematic reviews · 2018
    Pooled it
  20. Trial

291 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors.

S K AuroraSwedish Neuroscience Institute, USA. Sheena.Aurora@swedish.org
D W Dodick
C C Turkel
R E DeGryse
S D Silberstein
R B Lipton
H C Diener
M F Brin
PREEMPT 1 Chronic Migraine Study Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThis is the first of a pair of studies designed to assess efficacy, safety and tolerability of onabotulinumtoxinA (BOTOX) as headache prophylaxis in adults with chronic migraine.

methodsThe Phase III REsearch Evaluating Migraine Prophylaxis Therapy 1 (PREEMPT 1) is a phase 3 study, with a 24-week, double-blind, parallel-group, placebo-controlled phase followed by a 32-week, open-label phase. Subjects were randomized (1:1) to injections every 12 weeks of onabotulinumtoxinA (155 U-195 U; n = 341) or placebo (n = 338) (two cycles). The primary endpoint was mean change from baseline in headache episode frequency at week 24.

resultsNo significant between-group difference for onabotulinumtoxinA versus placebo was observed for the primary endpoint, headache episodes (-5.2 vs. -5.3; p = 0.344). Large within-group decreases from baseline were observed for all efficacy variables. Significant between-group differences for onabotulinumtoxinA were observed for the secondary endpoints, headache days (p = .006) and migraine days (p = 0.002). OnabotulinumtoxinA was safe and well tolerated, with few treatment-related adverse events. Few subjects discontinued due to adverse events.

conclusionsThere was no between-group difference for the primary endpoint, headache episodes. However, significant reductions from baseline were observed for onabotulinumtoxinA for headache and migraine days, cumulative hours of headache on headache days and frequency of moderate/severe headache days, which in turn reduced the burden of illness in adults with disabling chronic migraine.

Indexed as

AdolescentAdultAgedBotulinum Toxins, Type AChronic DiseaseDouble-Blind MethodFemaleHumansMaleMiddle AgedMigraine DisordersNeuromuscular AgentsTreatment OutcomeYoung AdultBotulinum Toxins, Type ANeuromuscular Agents

Identifiers

PMID20647170

What OpenQuestion holds

Textmetadata
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.