Regional Targeted Subcutaneous Injection of Botulinum Neurotoxin Type A in Refractory Chronic Migraine: A Randomized, Double-Blind, Placebo-Controlled Study
Francesco Bono,
Maria Rosaria Mazza,
Giuseppe Magro,
Giorgio Spano,
Giovanni Idone,
Vincenzo Laterza,
Denise Tedeschi,
Francesco Pucci,
Antonio Gambardella,
Alessia Sarica
Affiliations
Francesco Bono
Headache Center, and Center for Botulinum Toxin Therapy, Neurology Unit, Azienda Ospedaliero-Universitaria “Mater Domini”, 88100 Catanzaro, Italy
Maria Rosaria Mazza
Headache Center, and Center for Botulinum Toxin Therapy, Neurology Unit, Azienda Ospedaliero-Universitaria “Mater Domini”, 88100 Catanzaro, Italy
Giuseppe Magro
Headache Center, and Center for Botulinum Toxin Therapy, Neurology Unit, Azienda Ospedaliero-Universitaria “Mater Domini”, 88100 Catanzaro, Italy
Giorgio Spano
Headache Center, and Center for Botulinum Toxin Therapy, Neurology Unit, Azienda Ospedaliero-Universitaria “Mater Domini”, 88100 Catanzaro, Italy
Giovanni Idone
Headache Center, and Center for Botulinum Toxin Therapy, Neurology Unit, Azienda Ospedaliero-Universitaria “Mater Domini”, 88100 Catanzaro, Italy
Vincenzo Laterza
Headache Center, and Center for Botulinum Toxin Therapy, Neurology Unit, Azienda Ospedaliero-Universitaria “Mater Domini”, 88100 Catanzaro, Italy
Denise Tedeschi
Headache Center, and Center for Botulinum Toxin Therapy, Neurology Unit, Azienda Ospedaliero-Universitaria “Mater Domini”, 88100 Catanzaro, Italy
Francesco Pucci
Neurology Unit, Department of Medical and Surgical Sciences, Magna Graecia University of Catanzaro, 88100 Catanzaro, Italy
Antonio Gambardella
Neurology Unit, Department of Medical and Surgical Sciences, Magna Graecia University of Catanzaro, 88100 Catanzaro, Italy
Alessia Sarica
Neuroscience Research Center, Department of Medical and Surgical Sciences, Magna Graecia University of Catanzaro, 88100 Catanzaro, Italy
In this randomized, double-blind, placebo-controlled study, we evaluated the efficacy of an individualized technique of subcutaneous injection of botulinum toxin type A (BoNT-A) targeted (SjBoT) to the occipital or trigeminal skin area in non-responder patients with chronic migraine (CM). Patients who had not previously responded to at least two treatments of intramuscular injections of BoNT-A were randomly assigned (2:1) to receive two subcutaneous administrations of BoNT-A (up to 200 units) with the SjBoT injection paradigm or placebo. Following the skin area where the maximum pain began, treatment was given in the trigeminal or occipital region bilaterally. The primary endpoint changed in monthly headache days from baseline to the last 4 weeks. Among 139 randomized patients, 90 received BoNT-A and 49 received placebo, and 128 completed the double-blind phase. BoNT-A significantly reduced monthly headache days versus placebo (−13.2 versus −1.2; p p = 0.028), also differed. Thus, in non-responder patients with CM, BoNT-A significantly reduced migraine days when administered according to the “follow the origin of maximum pain” approach using SjBoT injection paradigm.
