Cephalalgia : an international journal of headache | 2021
BoNT-A efficacy in high frequency migraine: an open label, single arm, exploratory study applying the PREEMPT paradigm.
Abstract
INTRODUCTION\nIn this open label, single-arm trial we evaluated the efficacy of onabotulinum toxin-A in the prevention of high-frequency episodic migraine (8-14 migraine days/month).\n\n\nMETHODS\nWe enrolled 32 high-frequency episodic migraine subjects (age 44.8\u2009±\u200911.9 years, 11.0\u2009±\u20092.2 migraine days, 11.5\u2009±\u20092.1 headache days, 7 females). After a 28-day baseline period, subjects underwent 4 subsequent onabotulinum toxin-A treatments according to the phase III research evaluating migraine prophylaxis therapy (PREEMPT) paradigm, 12-weeks apart. The primary outcome was the reduction of monthly migraine days from baseline in the 12-week period following the last onabotulinum toxin-A treatment.\n\n\nRESULTS\nOnabotulinum toxin-A reduced monthly migraine days by 3.68 days (-33.1%, p\u2009<\u20090.01). Thirty-nine percent of the patients experienced a ≥50% reduction in monthly migraine days. Onabotulinum toxin-A also reduced the number of headache days (-33.9%, p\u2009<\u20090.01) and the intake of acute medications (-22.9%, p\u2009=\u20090.03). Disability and quality of life (QoL) scores improved markedly (migraine disability assessment (MIDAS) -41.7%; migraine specific questionnaire (MSQ) -31.7%, p\u2009<\u20090.01).\n\n\nCONCLUSIONS\nThe findings suggest that, when administered according to the PREEMPT paradigm, onabotulinum toxin-A is effective in the prevention of high-frequency episodic migraine.Trial Registration: NCT04578782.