Long-term study of the efficacy and safety of OnabotulinumtoxinA for the prevention of chronic migraine: COMPEL study

Autor: Amelia Orejudos, Marshall C. Freeman, Richard J Stark, Aubrey Manack Adams, Andrew M. Blumenfeld
Jazyk: angličtina
Rok vydání: 2018
Předmět:
Male
Internationality
Acetylcholine Release Inhibitors
lcsh:Medicine
Medical Records
0302 clinical medicine
Chronic Migraine
Long-term
Medicine
030212 general & internal medicine
Prospective Studies
Registries
Botulinum Toxins
Type A
Prospective cohort study
Neck pain
Muscle Weakness
Neck Pain
medicine.diagnostic_test
General Medicine
Middle Aged
Rash
Treatment Outcome
Tolerability
Female
medicine.symptom
Safety
Research Article
Adult
medicine.medical_specialty
Efficacy
Migraine Disorders
Physical examination
03 medical and health sciences
Double-Blind Method
Internal medicine
OnabotulinumtoxinA
Humans
Adverse effect
Chronic migraine
Aged
business.industry
Prophylaxis
lcsh:R
Anesthesiology and Pain Medicine
Concomitant
Chronic Disease
Neurology (clinical)
business
030217 neurology & neurosurgery
Follow-Up Studies
Zdroj: The Journal of Headache and Pain
The Journal of Headache and Pain, Vol 19, Iss 1, Pp 1-12 (2018)
ISSN: 1129-2377
1129-2369
0151-6892
Popis: Background OnabotulinumtoxinA is approved for the prevention of headache in those with chronic migraine (CM); however, more clinical data on the risk-benefit profile for treatment beyond one year is desirable. Methods The Chronic Migraine OnabotulinuMtoxinA Prolonged Efficacy open Label (COMPEL) Study (ClinicalTrials.gov, NCT01516892) is an international, multicenter, open-label long-term prospective study. Adults with CM received 155 U of onabotulinumtoxinA (31 sites in a fixed-site, fixed-dose paradigm across 7 head/neck muscles) every 12 weeks (±7 days) for 9 treatment cycles (108 weeks). The primary outcome was headache day reductions at 108 weeks; secondary outcomes were headache day reductions at 60 weeks and change in the 6-item Headache Impact Test (HIT-6) score. Safety and tolerability were assessed by reviewing the frequency and nature of adverse events (AEs). AEs were determined at each visit through patient self-report, general non-directed and, for specific AEs, directed questioning, and physical examination. Subgroup analyses for safety and efficacy included, but were not limited to, patients with/without concomitant oral preventive treatment and acute medication overuse at baseline. Results Enrolled patients (N = 716) were 18–73 years old and most were female (n = 607, 84.8%). At baseline, patients reported an average 22.0 (SD = 4.8) headache days per month. 52.1% of patients (n = 373) completed the study. By 60 and 108 weeks, a significant reduction in headache days (− 9.2 days and − 10.7 days, respectively, P
Databáze: OpenAIRE
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