Safety and efficacy of NeuroBloc (botulinum toxin type B) in type A–responsive cervical dystonia

Brashear, Allison; Lew, Mark F.; Dykstra, D. D.; Comella, Cynthia L.; Factor, Stewart A.; Rodnitzky, Robert L.; Trosch, Richard; Singer, C.; Brin, Mitchell F.; Murray, J. J.; Wallace, J. D.; Willmer-Hulme, A.; Koller, M.

doi:10.1212/wnl.53.7.1439

Cited by 308 publications

(227 citation statements)

References 17 publications

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“…For example, a mean reduction in TWSTRS‐Total score of 9.9 has been reported for incobotulinumtoxinA 120 U,12 10.9 for incobotulinumtoxinA 240 U,12 9.3 for botulinum toxin type B 5,000 U,13 11.7 for botulinum toxin type B 10,000 U,13 9.9 for abobotulinumtoxinA 500 U,14 and a least squares mean reduction of approximately 14 for abobotulinumtoxinA 500 U 15. However, these previous studies were larger, double blind, and placebo controlled, so these differences may not be meaningful.…”

Section: Discussionmentioning

confidence: 99%

Injectable DaxibotulinumtoxinA in Cervical Dystonia: A Phase 2 Dose‐Escalation Multicenter Study

Jankovic

Truong

Patel³

et al. 2018

Movement Disord Clin Pract

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BackgroundInjectable daxibotulinumtoxinA (an investigational botulinum toxin, RT002) may offer a more prolonged duration of response—and therefore less frequent dosing—than onabotulinumtoxinA.ObjectivesTo perform a phase 2, open‐label, dose‐escalation study to assess the efficacy and safety of daxibotulinumtoxinA in cervical dystonia.MethodsSubjects with moderate‐to‐severe isolated cervical dystonia were enrolled in sequential cohorts to receive a single open‐label, intramuscular dose of injectable daxibotulinumtoxinA of up to 200 U (n = 12), 200–300 U (n = 12), or 300–450 U (n = 13; https://clinicaltrials.gov identifier NCT02706795).ResultsOverall, 33/37 enrollees completed the trial. DaxibotulinumtoxinA was associated with mean reductions in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)‐Total score of 16.8 (38%) at week 4, 21.3 (50%) at week 6, and 12.8 (30%) at week 24. The proportion of subjects who were responders (achieved ≥ 20% reduction in TWSTRS‐Total score) was 94% at week 6 and 68% at week 24. The median duration of response (time until > 20% of the improvement in TWSTRS‐Total score achieved at week 4 was no longer retained or re‐treatment was needed) was 25.3 weeks (95% CI, 20.14–26.14 weeks). There were no serious adverse events and there was no apparent dose‐related increase in the incidence of adverse events. The most common treatment‐related adverse events were dysphagia (14%) and injection site erythema (8%).ConclusionsPreliminary assessments suggest that injectable daxibotulinumtoxinA at doses up to 450 U is well tolerated and may offer prolonged efficacy in the treatment of cervical dystonia. Further studies involving larger numbers of patients are now warranted.

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Section: Discussionmentioning

confidence: 99%

Injectable DaxibotulinumtoxinA in Cervical Dystonia: A Phase 2 Dose‐Escalation Multicenter Study

Jankovic

Truong

Patel³

et al. 2018

Movement Disord Clin Pract

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“…6,7,11 Thus, the AE data obtained in controlled studies with doses of 2500 and 5000 U may not be entirely applicable to clinical practice. As shown in Figure 1, an apparent increase in dosages was observed over time in the present study, although the numbers of patients at each injection were not the same, with only a few patients having received 6 or 7 injections.…”

Section: Discussionmentioning

confidence: 99%

“…In 2000, a botulinum neurotoxin product based on the B serotype that also significantly improves the symptoms of cervical dystonia was introduced in many European countries and the United States. 6,7 Acceptable tolerability has been reported with the A and B serotypes in the treatment of cervical dystonia. [3][4][5][6][7] However, according to a MEDLINE search (key terms, botulinum toxin type A, botulinum toxin type B, cervical dystonia, torticollis, comparison, BOTOX ,* and MYOBLOC , † a growing amount of research and experience suggests that the specific AE profiles of these 2 preparations differ somewhat, 8 although no published, controlled studies have directly compared these botulinum neurotoxins in the treatment of cervical dystonia.…”

Section: Introductionmentioning

confidence: 99%

“…6,7 Acceptable tolerability has been reported with the A and B serotypes in the treatment of cervical dystonia. [3][4][5][6][7] However, according to a MEDLINE search (key terms, botulinum toxin type A, botulinum toxin type B, cervical dystonia, torticollis, comparison, BOTOX ,* and MYOBLOC , † a growing amount of research and experience suggests that the specific AE profiles of these 2 preparations differ somewhat, 8 although no published, controlled studies have directly compared these botulinum neurotoxins in the treatment of cervical dystonia. In particular, xerostomia, or dry mouth, is one of the most common AEs with type B in the treatment of cervical dystonia, occurring in 17 of 39 patients (43.6%) treated with 10,000 U in a double-blind trial 6 and in 21 of 24 patients (87.5%) treated with a mean of 11,310 U in an open-label trial.…”

Section: Introductionmentioning

confidence: 99%

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Severity and impact of xerostomia in patients treated with botulinum toxin type b for cervical dystonia: Observations on the quality of life of patients with xerostomia

Hogan

Charles

Watts³

et al. 2004

Current Therapeutic Research

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Background: Although dry mouth (xerostomia) has been reported with botulinum toxin type B used as treatment for cervical dystonia, the impact of this adverse effect (AE) on patients' activities of daily living (ADLs) has not been assessed.Objective: The aim of this study was to examine the severity, duration, and impact of xerostomia in patients with cervical dystonia who reported this AE in routine clinical practice following treatment with botulinum toxin type B.Methods: In this uncontrolled study, investigators at 5 study centers across the United States retrospectively identified patients who were diagnosed with cervical dystonia and had received Ն1 treatment with botulinum toxin type B injection and who had reported xerostomia, based on patients' charts. These patients were mailed a survey that included questions about their treatment history, disease severity, and xerostomia (severity, onset, duration, change with subsequent injections, and effects on dental and oral health), as well as an 8-item Patient Benefit Questionnaire (PBQ), which was designed to assess the impact of xerostomia symptoms on patients' ADLs.Results: A total of 45 patients received a mean of 2.91 injections with botulinum toxin type B (mean dose per injection, 11,958 U), with a total of 131 injections. The mean severity of patient-rated xerostomia following the first injection of botulinum toxin type B was 3.88 on a scale of 1 (mild) to 5 (severe), and this rating did not change for patients who received subsequent injections (mean, 3.76). Following a typical injection of botulinum toxin type B, xerostomia Accepted for publication January 20, 2004. Reproduction in whole or part is not permitted.0011-393X/04/$19.00 began a mean (SD) of 4.82 (3.32) days later and persisted for a mean (SD) duration of 5.56 (3.57) weeks. The overall mean score on the 10-point PBQ prior to botulinum toxin treatment was 8.89, which decreased to 5.42 following botulinum toxin type B injection (lower scores indicate more severe xerostomia). C U R R E N T T H E R A P E U T I C R E S E A R C H ாV Conclusions:This study of patients with cervical dystonia suggests that patients who experience xerostomia following treatment with botulinum toxin type B injection, on average, rate their symptoms as moderate to severe and exhibit reduced scores on the PBQ-a questionnaire on which lower scores indicate greater negative impact of xerostomia on patients' ADLs. (Curr Ther Res Clin Exp.

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“…All six studies depicted superiority of BoNTs to placebo in terms of efficacy and safety. [22][23][24][25][26][27] The trihexyphenidyl study 28 was conducted with BoNT-A (Dysport), which was proved to be more efficacious than tirhexyphenidyl in improving motor disability and movements while producing fewer adverse effects. The AAN subcommittee concluded that BoNTs are established as safe and effective for the treatment of CD, and that BoNT injections should be offered as a treatment option to patients with CD (level A).…”

Section: Medical Treatmentmentioning

confidence: 99%

Current Considerations for the Management of Cervical Dystonia

Jabbari¹

2008

US Neurology

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Safety and efficacy of NeuroBloc (botulinum toxin type B) in type A–responsive cervical dystonia

Abstract: Botulinum toxin type B (NeuroBloc) is safe and efficacious at 5,000 U and 10,000 U for the management of patients with cervical dystonia.

Cited by 308 publications

References 17 publications

Injectable DaxibotulinumtoxinA in Cervical Dystonia: A Phase 2 Dose‐Escalation Multicenter Study

Injectable DaxibotulinumtoxinA in Cervical Dystonia: A Phase 2 Dose‐Escalation Multicenter Study

Severity and impact of xerostomia in patients treated with botulinum toxin type b for cervical dystonia: Observations on the quality of life of patients with xerostomia

Current Considerations for the Management of Cervical Dystonia

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