C Lungu1, E Considine2, S Zahir1, B Ponsati3, S Arrastia3, M Hallett2. 1. Office of the Clinical Director, NINDS, NIH, Bethesda, MD, USA. 2. Human Motor Control Section, Medical Neurology Branch, NINDS, NIH, Bethesda, MD, USA. 3. BCN Peptides S.A., Barcelona, Spain.
Abstract
BACKGROUND AND PURPOSE: Injectable botulinum neurotoxin (BoNT) is the principal effective treatment for blepharospasm (BSP). This trial explores the safety and efficacy of topical acetyl hexapeptide-8 (AH8), a competitive SNAP25 inhibitor, as a potential new therapy in BSP. METHODS: Double-blind, placebo-controlled, randomized trial of daily topical application of AH8 in 24 patients with BSP. The primary outcome was time to return to baseline Jankovic Blepharospasm Rating Scale (JBRS) after a BoNT injection simultaneously with the initiation of AH8. Patients displaying a strictly regular pattern of response to 3-monthly injections of BoNT were included. RESULTS: There were no significant adverse events. There was a trend for longer time until return to baseline JBRS after injection in the active group compared to placebo (3.7 months vs. 3.0 months), and for better scores in the active group. One-third (4/12) of the patients in the active group had a considerable extension of symptom control after BoNT (range: 3.3-7.1 months). CONCLUSIONS: Topical AH8 is safe and promising for extending the duration of action of BoNT therapy for BSP. Published 2012. This article is a U.S. Government work and is in the public domain in the USA. European Journal of Neurology
BACKGROUND AND PURPOSE: Injectable botulinum neurotoxin (BoNT) is the principal effective treatment for blepharospasm (BSP). This trial explores the safety and efficacy of topical acetyl hexapeptide-8 (AH8), a competitive SNAP25 inhibitor, as a potential new therapy in BSP. METHODS: Double-blind, placebo-controlled, randomized trial of daily topical application of AH8 in 24 patients with BSP. The primary outcome was time to return to baseline Jankovic Blepharospasm Rating Scale (JBRS) after a BoNT injection simultaneously with the initiation of AH8. Patients displaying a strictly regular pattern of response to 3-monthly injections of BoNT were included. RESULTS: There were no significant adverse events. There was a trend for longer time until return to baseline JBRS after injection in the active group compared to placebo (3.7 months vs. 3.0 months), and for better scores in the active group. One-third (4/12) of the patients in the active group had a considerable extension of symptom control after BoNT (range: 3.3-7.1 months). CONCLUSIONS: Topical AH8 is safe and promising for extending the duration of action of BoNT therapy for BSP. Published 2012. This article is a U.S. Government work and is in the public domain in the USA. European Journal of Neurology
Authors: D M Simpson; A Blitzer; A Brashear; C Comella; R Dubinsky; M Hallett; J Jankovic; B Karp; C L Ludlow; J M Miyasaki; M Naumann; Y So Journal: Neurology Date: 2008-05-06 Impact factor: 9.910
Authors: Joseph Jankovic; Christopher Kenney; Susanne Grafe; Roman Goertelmeyer; George Comes Journal: Mov Disord Date: 2009-02-15 Impact factor: 10.338
Authors: C Blanes-Mira; J Clemente; G Jodas; A Gil; G Fernández-Ballester; B Ponsati; L Gutierrez; E Pérez-Payá; A Ferrer-Montiel Journal: Int J Cosmet Sci Date: 2002-10 Impact factor: 2.970