Trial reportCephalalgia : an international journal of headache2016
OnabotulinumtoxinA improves quality of life and reduces impact of chronic migraine over one year of treatment: Pooled results from the PREEMPT randomized clinical trial program.
Trial report in Cephalalgia : an international journal of headache, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 46 papers, 7 of them syntheses that pooled it.
What it found
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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.
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.
Who cites it
46 citing papers in PubMed, 7 syntheses or guidelines pooled it, 87 citations in OpenAlex.
- Botulinum Toxin Type A for Preventing Facial Trauma and Hypertrophic Scars: A Meta-Analysis and Trial Sequential Analysis.Journal of cosmetic dermatology · 2025Pooled it
- Preventive drug treatments for adults with chronic migraine: a systematic review with economic modelling.Health technology assessment (Winchester, England) · 2024Pooled it
- Clinical effectiveness of pharmacological interventions for managing chronic migraine in adults: a systematic review and network meta-analysis.The journal of headache and pain · 2023Pooled it
- Pooled it
- Botox (OnabotulinumtoxinA) for Treatment of Migraine Symptoms: A Systematic Review.Pain research & management · 2022Pooled it
- Botulinum toxins for the prevention of migraine in adults.The Cochrane database of systematic reviews · 2018Pooled it
- Assessing the impact of headaches and the outcomes of treatment: A systematic review of patient-reported outcome measures (PROMs).Cephalalgia : an international journal of headache · 2018Pooled it
- Trial
- Treatment of chronic migraine with Botox (onabotulinumtoxinA): Development, insights, and impact.Medicine · 2023Trial
- HIT-6 and EQ-5D-5L in patients with migraine: assessment of common latent constructs and development of a mapping algorithm.The European journal of health economics : HEPAC : health economics in prevention and care · 2022Trial
- Acupuncture as prophylaxis for chronic migraine: a protocol for a single-blinded, double-dummy randomised controlled trial.BMJ open · 2018Trial
- Patient-Reported Outcomes from a 1-Year, Real-World, Head-to-Head Comparison of OnabotulinumtoxinA and Topiramate for Headache Prevention in Adults With Chronic Migraine.Journal of primary care & community healthTrial
- Optimizing Chronic Migraine Care: The Impact of Advanced Practice Nurse Involvement in OnabotulinumtoxinA Administration.Revista de neurologia · 2026Article
- Review
- Botulinum toxin for provoked vestibulodynia.The Cochrane database of systematic reviews · 2025Article
- Insights from 25 years of onabotulinumtoxinA in migraine - mechanisms and management.Nature reviews. Neurology · 2024Review
- Migraine Disability Improvement during Treatment with Galcanezumab in Patients with Chronic and High Frequency Episodic Migraine.Neurology international · 2023Article
- Review
- Article
- OnabotulinumtoxinA in chronic migraine: is the response dose dependent?BMC neurology · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundChronic migraine (CM) is associated with high impact and reduced health-related quality of life (HRQoL).
methodsPatients with CM from PREEMPT (Phase 3 REsearch Evaluating Migraine Prophylaxis Therapy) were randomized (1:1) to receive onabotulinumtoxinA or placebo for two 12-week cycles in the double-blind (DB) phase, followed by three 12-week cycles of open-label (OL) onabotulinumtoxinA (onabotulinumtoxinA/onabotulinumtoxinA (O/O) and placebo/onabotulinumtoxinA (P/O) groups, respectively). HRQoL endpoints were assessed over 56 weeks using the Headache Impact Test (HIT-6) and the Migraine-Specific Quality of Life Questionnaire (MSQ). HIT-6 score reductions ≥2.3 and ≥5 denoted between-group minimally important difference and within-patient clinically meaningful response, respectively.
resultsA total of 1236 participants (O/O, n = 607; P/O, n = 629) participated in both phases. The DB phase showed significantly reduced HIT-6 and MSQ for onabotulinumtoxinA versus placebo (all p < 0.001). The OL phase showed significantly reduced HIT-6 for O/O versus P/O at weeks 28, 36, and 48, but not 56. All three MSQ domains showed improved HRQoL relative to baseline, but only the role restrictive domain showed a significant difference between O/O and P/O at week 56.
conclusionsBenefits of onabotulinumtoxinA on HRQoL versus baseline persisted throughout the OL phase. Statistical superiority in favor of O/O was demonstrated for HIT-6 through 48 weeks and for MSQ (role restrictive) at 56 weeks.
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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.