Trial reportEuropean journal of neurology2014
Pooled analysis of the safety and tolerability of onabotulinumtoxinA in the treatment of chronic migraine.
Trial report in European journal of neurology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers.
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
30 citing papers in PubMed, 64 citations in OpenAlex.
- OnabotulinumtoxinA for the treatment of major depressive disorder: a phase 2 randomized, double-blind, placebo-controlled trial in adult females.International clinical psychopharmacology · 2020Trial
- Cost-Effectiveness Analysis of Erenumab Versus OnabotulinumtoxinA for Patients with Chronic Migraine Attacks in Greece.Clinical drug investigation · 2019Trial
- Review
- Article
- Article
- Insights from 25 years of onabotulinumtoxinA in migraine - mechanisms and management.Nature reviews. Neurology · 2024Review
- Botulinum toxin type A-targeted SPP1 contributes to neuropathic pain by the activation of microglia pyroptosis.World journal of psychiatry · 2024Article
- Observational
- Real-world effectiveness of Anti-CGRP monoclonal antibodies compared to OnabotulinumtoxinA (RAMO) in chronic migraine: a retrospective, observational, multicenter, cohort study.The journal of headache and pain · 2024Observational
- Long-term safety of OnabotulinumtoxinA treatment in chronic migraine patients: a five-year retrospective study.Frontiers in neurology · 2024Article
- Observational
- Review
- Article
- Article
- Instrumental assessment of physiotherapy and onabolulinumtoxin-A on cervical and headache parameters in chronic migraine.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2022Observational
- Calcitonin Gene-Related Peptide Monoclonal Antibodies Versus Botulinum Neurotoxin a in the Preventive Treatment of Chronic Migraine: An Adjusted Indirect Treatment Comparison Meta-Analysis.Frontiers in pharmacology · 2021Review
- Consensus of the Hellenic Headache Society on the diagnosis and treatment of migraine.The journal of headache and pain · 2019Article
- Health state utilities associated with attributes of migraine preventive treatments based on patient and general population preferences.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2019Article
- [Treatment of chronic migraine with botulinum neurotoxin A : Expert recommendations of the German Migraine and Headache Society].Der Nervenarzt · 2018Review
- Guideline on the use of onabotulinumtoxinA in chronic migraine: a consensus statement from the European Headache Federation.The journal of headache and pain · 2018Article
Corrections and comments
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Authors and funding
7 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
background and purposeOnabotulinumtoxinA was effective and well tolerated for prophylaxis of headache in patients with chronic migraine (CM) in two randomized, double-blind, placebo-controlled, phase 3 trials. To further assess the safety and tolerability of onabotulinumtoxinA in CM prophylaxis in adults, the pooled safety data from four double-blind, placebo-controlled trials were analyzed.
methodsThe pooled analysis included two phase 2 and two phase 3 double-blind, placebo-controlled trials. The safety population was 2436 patients, 1997 of whom received ≥1 dose of onabotulinumtoxinA. The studies shared similar dosing intervals (approximately 12 weeks) with doses between 75 and 260 U. Safety assessments included adverse events (AEs), physical examination and clinical laboratory tests.
resultsOnabotulinumtoxinA was safe and well tolerated, with a low discontinuation rate (3.4%) due to AEs. The majority of patients in this pooled analysis received doses between 150 and 200 U, with an average of 163 U per treatment cycle. Of the 1997 patients who received any onabotulinumtoxinA injections, 1455 patients (72.9%) reported at least one AE. Neck pain (12.6%) was the most common onabotulinumtoxinA-associated AE, followed by muscle weakness (8.0%), musculoskeletal stiffness (6.1%) and eyelid ptosis (4.6%). Serious AEs were infrequent, occurring in 5.4% of patients who received any onabotulinumtoxinA treatment and 3.0% of patients receiving placebo. AEs were consistent with the known tolerability profile of onabotulinumtoxinA.
conclusionsMultiple treatments with onabotulinumtoxinA at doses of 75-260 U administered every 12 weeks, and up to five treatment cycles, were well tolerated for the prophylaxis of headache in adults with CM.
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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.