A double blind, randomised, parallel group study to investigate the dose equivalence of Dysport  and Botox  in the treatment of cervical dystonia

Odergren, Tomas; Hjaltason, Haukur; Kaakkola, Seppo; Solders, Göran; Hanko, Jennifer; Fehling, Clas; Marttila, Reijo J.; Lundh, Håkan; Gedin, S; Westergren, I; Richardson, A.; Dott, C; Cohen, Hart

doi:10.1136/jnnp.64.1.6

Cited by 273 publications

(204 citation statements)

References 11 publications

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“…In this dose ratio, the 2 products appear to have the same therapeutic equivalence. 17 Although the 3 doses of Dysport that were evaluated in this study resulted in significant reduction in muscle spasticity, their overall effect on the global disability scores was minimal. This is hardly surprising because the global assessment scales used have a low level of sensitivity.…”

Section: Discussionmentioning

confidence: 78%

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Compare the Efficacy and Safety of Three Doses of Botulinum Toxin Type A (Dysport) With Placebo in Upper Limb Spasticity After Stroke

Bakheit

Thilmann

Ward

et al. 2000

Stroke

276

191

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Background and Purpose —We sought to define an effective and safe dose of botulinum toxin type A (Dysport) for the treatment of upper limb muscle spasticity due to stroke. Methods —This was a prospective, randomized, double-blind, placebo-controlled, dose-ranging study. Patients received either a placebo or 1 of 3 doses of Dysport (500, 1000, 1500 U) into 5 muscles of the affected arm. Efficacy was assessed periodically by the Modified Ashworth Scale and a battery of functional outcome measures. Results —Eighty-three patients were recruited, and 82 completed the study. The 4 study groups were comparable at baseline with respect to their demographic characteristics and severity of spasticity. All doses of Dysport studied showed a significant reduction from baseline of muscle tone compared with placebo. However, the effect on functional disability was not statistically significant and was best at a dose of 1000 U. There were no statistically significant differences between the groups in the incidence of adverse events. Conclusions —The present study suggests that treatment with Dysport reduces muscle tone in patients with poststroke upper limb spasticity. Treatment was effective at doses of Dysport of 500, 1000, and 1500 U. The optimal dose for treatment of patients with residual voluntary movements in the upper limb appears to be 1000 U. Dysport is safe in the doses used in this study.

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Section: Discussionmentioning

confidence: 78%

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Compare the Efficacy and Safety of Three Doses of Botulinum Toxin Type A (Dysport) With Placebo in Upper Limb Spasticity After Stroke

Bakheit

Thilmann

Ward

et al. 2000

Stroke

276

191

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“…The third Class I study 23 compared the effect of onaBoNT-A 70-240 U with aboBoNT-A 240-720 U and observed no difference in the improvement of posttreatment Tsui scores at 4 weeks (mean difference 0.2, 95% CI 20.7 to 1.1, lower scores with aboBoNT-A). In a Class II 9-month randomized, double-blind, multicenter, noninferiority, 2-period crossover study with a 2.5:1 (aboBoNT-A:onaBoNT-A) protocol involving 103 patients with CD, 94 of whom completed the study, there were no statistically significant differences between aboBoNT-A and onaBoNT-A in mean changes in the Tsui scale (0.8 points favoring onaBoNT-A, 95% CI 20.1 to 1.7), TWSTRS, global impression, or frequency of AEs from baseline to 4 weeks after each injection.…”

mentioning

confidence: 99%

Practice guideline update summary: Botulinum neurotoxin for the treatment of blepharospasm, cervical dystonia, adult spasticity, and headache

et al. 2016

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Objective: To update the 2008 American Academy of Neurology (AAN) guidelines regarding botulinum neurotoxin for blepharospasm, cervical dystonia (CD), headache, and adult spasticity. Methods:We searched the literature for relevant articles and classified them using 2004 AAN criteria.Results and recommendations: Blepharospasm: OnabotulinumtoxinA (onaBoNT-A) and incobotulinumtoxinA (incoBoNT-A) are probably effective and should be considered (Level B). AbobotulinumtoxinA (aboBoNT-A) is possibly effective and may be considered (Level C). CD: AboBoNT-A and rimabotulinumtoxinB (rimaBoNT-B) are established as effective and should be offered (Level A), and onaBoNT-A and incoBoNT-A are probably effective and should be considered (Level B). Adult spasticity: AboBoNT-A, incoBoNT-A, and onaBoNT-A are established as effective and should be offered (Level A), and rimaBoNT-B is probably effective and should be considered (Level B), for upper limb spasticity. AboBoNT-A and onaBoNT-A are established as effective and should be offered (Level A) for lower-limb spasticity. Headache: OnaBoNT-A is established as effective and should be offered to increase headache-free days (Level A) and is probably effective and should be considered to improve health-related quality of life (Level B) in chronic migraine. OnaBoNT-A is established as ineffective and should not be offered for episodic migraine (Level A) and is probably ineffective for chronic tension-type headaches (Level B). Neurology ® 2016;86:1818-1826 GLOSSARY AAN 5 American Academy of Neurology; aboBoNT-A 5 abobotulinumtoxinA; AE 5 adverse event; BDI 5 Blepharospasm Disability Index; BoNT 5 botulinum neurotoxin; CD 5 cervical dystonia; CI 5 confidence interval; CM 5 chronic migraine; DAS 5 Disability Assessment Scale; EM 5 episodic migraine; incoBoNT-A 5 incobotulinumtoxinA; onaBoNT-A 5 onabotulinumtoxinA; QOL 5 quality of life; RD 5 risk difference; rimaBoNT-B 5 rimabotulinumtoxinB; RMT 5 randomized, masked trials; TWSTRS 5 Toronto Western Spasmodic Torticollis Rating Scale; TZD 5 tizanidine.

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“…Various strains of Clostridium produce protein complexes of different sizes, and all type A strains produce complexes of ∼300 kDa, ∼500 kDa and ∼900 kDa (Odergren et al, 1998), while none produce the ∼150 kDa peptide without NAPs. The NAPs in onabotulinumtoxinA include non-toxic hemagglutinins that stabilize the biological activity of the product in vivo and enable the complex to adhere to muscle tissue (Johnson and Bradshaw, 2001).…”

Section: Manufacturing Of Onabotulinumtoxinamentioning

confidence: 99%

Pharmacological differences and clinical implications of various botulinum toxin preparations: a critical appraisal

Ferrari¹,

Manca²,

Tugnoli³

et al. 2018

Functional Neurology

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SummaryThree different type A botulinum neurotoxins (BoNTAs) -onabotulinumtoxinA, abobotulinumtoxinA and incobotulinumtoxinA) -are currently marketed in Europe to treat several conditions. Differences between BoNTA preparations, which depend on their specific biotypes and manufacturing processes, lead to clinically relevant pharmacotherapeutic dissimilarities. All three available products are separately recognized and reviewed in American Academy of Neurology guidelines. The neurotoxin load/100U is likewise different among the different BoNTAs, with the result that the specific potency of the 150kD BoNTA neurotoxin is calculated as 137 units/ng for onabotulinumtoxinA, 154 units/ng for abobotulinumtoxinA, and 227 units/ng for incobotulinumtoxinA. It is important for clinicians to have all three BoNTAs available in order to choose the most suitable preparation for the specific indication in the single patient. Commercially available BoNTAs must be recognized as different from one another, and therefore as non-interchangeable. The essential experience of the clinician is of the utmost importance in choosing the most appropriate treatment.

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A double blind, randomised, parallel group study to investigate the dose equivalence of Dysport and Botox in the treatment of cervical dystonia

Cited by 273 publications

References 11 publications

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Compare the Efficacy and Safety of Three Doses of Botulinum Toxin Type A (Dysport) With Placebo in Upper Limb Spasticity After Stroke

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Compare the Efficacy and Safety of Three Doses of Botulinum Toxin Type A (Dysport) With Placebo in Upper Limb Spasticity After Stroke

Practice guideline update summary: Botulinum neurotoxin for the treatment of blepharospasm, cervical dystonia, adult spasticity, and headache

Pharmacological differences and clinical implications of various botulinum toxin preparations: a critical appraisal

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