This website is for UK Healthcare Professionals only

This promotional material is intended for UK Healthcare Professionals only.
BOTOX® (botulinum toxin type A) Prescribing Information and adverse event reporting information can be found below.

BOTOX® has demonstrated efficacy in post‑stroke spasticity (PSS) in both the upper and lower limb5-9

BOTOX® has demonstrated efficacy in upper limb PSS

BOTOX® helped significantly more patients achieve upper limb functional goals vs placebo6

Primary endpoint: Functional disability was measured using the four-point Disability Assessment Scale (hygiene, dressing, pain and limb position) at week 66

62% of wrist and finger spasticity patients treated with BOTOX® vs 27% treated with placebo reported improvements towards their functional goals at Week 6 (n=64 BOTOX® and n=62 placebo; P<0.001)6


BOTOX® significantly reduced finger flexor tone compared to placebo at both Week 6 (primary endpoint) and 12 (additional endpoint)6

Adapted from Brashear A, et al 2002.6

 

Study context: A phase 3, randomised, double-blind, placebo-controlled, multicentre trial assessed the efficacy and safety of BOTOX® in 126 subjects with increased flexor tone in the wrist and fingers after a stroke6.


BOTOX® significantly* reduced wrist flexor tone compared to placebo at both Week 6 (primary endpoint) and 12 (additional endpoint)6

Adapted from Brashear A, et al 2002.6

Study context: A phase 3, randomised, double-blind, placebo-controlled, multicentre trial assessed the efficacy and safety of BOTOX® in 126 subjects with increased flexor tone in the wrist and fingers after a stroke.6

BOTOX® has demonstrated efficacy in upper limb PSS

BOTOX® helped significantly more patients achieve upper limb functional goals vs placebo6

Primary endpoint: Functional disability was measured using the four-point Disability Assessment Scale (hygiene, dressing, pain and limb position) at week 66

62% of wrist and finger spasticity patients treated with BOTOX® vs 27% treated with placebo reported improvements towards their functional goals at Week 6 (n=64 BOTOX® and n=62 placebo; P<0.001)6


BOTOX® significantly reduced finger flexor tone compared to placebo at both Week 6 (primary endpoint) and 12 (additional endpoint)6

Adapted from Brashear A, et al 2002.6

 

Study context: A phase 3, randomised, double-blind, placebo-controlled, multicentre trial assessed the efficacy and safety of BOTOX® in 126 subjects with increased flexor tone in the wrist and fingers after a stroke6.


BOTOX® significantly* reduced wrist flexor tone compared to placebo at both Week 6 (primary endpoint) and 12 (additional endpoint)6

Adapted from Brashear A, et al 2002.6

Study context: A phase 3, randomised, double-blind, placebo-controlled, multicentre trial assessed the efficacy and safety of BOTOX® in 126 subjects with increased flexor tone in the wrist and fingers after a stroke.6

AUC, area under curve; MAS, Modified Ashworth Scale; PSLLS, post-stroke lower limb spasticity; PSS, post-stroke spasticity.

 

References

  1. Allergan. Data on file. INT/0423/2016
  2. Aurora SK, et al. Onabotulinum toxin A for treatment of chronic migraine: pooled analyses of the 56-week PREEMPT clinical program. Headache 2011;51(9):1358–73
  3. Blumenfeld AM, et al. Long-term study of the efficacy and safety of Onabotulinum toxin A for the prevention of chronic migraine: COMPEL study. J Headache Pain 2018;19(1):13
  4. AbbVie Data on file. Approval Dates for BOTOX® in UK. REF-112127.
  5. BOTOX® Summary of Product Characteristics. Available at: www.medicines.org.uk.
  6. Brashear A, et al. Intramuscular injection of botulinum toxin for the treatment of wrist and finger spasticity after a stroke. N Engl J Med 2002;347:395–400
  7. Kaji R, et al. Botulinum toxin type A in post-stroke lower limb spasticity: a multicenter, double-blind, placebo-controlled trial. J Neurol 2010;257(8):1330–37
  8. Wein T, et al. Onabotulinum toxin A for the treatment of post-stroke distal lower limb spasticity: a randomized trial. PM R. 2018;10(7):693–03
  9. Allergan, Data on file. 023: BOTOX®

 

References

  1. Allergan. Data on file. INT/0423/2016
  2. Aurora SK, et al. Onabotulinum toxin A for treatment of chronic migraine: pooled analyses of the 56-week PREEMPT clinical program. Headache 2011;51(9):1358–73
  3. Blumenfeld AM, et al. Long-term study of the efficacy and safety of Onabotulinum toxin A for the prevention of chronic migraine: COMPEL study. J Headache Pain 2018;19(1):13
  4. AbbVie Data on file. Approval Dates for BOTOX® in UK. REF-112127.
  5. BOTOX® Summary of Product Characteristics. Available at: www.medicines.org.uk.
  6. Brashear A, et al. Intramuscular injection of botulinum toxin for the treatment of wrist and finger spasticity after a stroke. N Engl J Med 2002;347:395–400
  7. Kaji R, et al. Botulinum toxin type A in post-stroke lower limb spasticity: a multicenter, double-blind, placebo-controlled trial. J Neurol 2010;257(8):1330–37
  8. Wein T, et al. Onabotulinum toxin A for the treatment of post-stroke distal lower limb spasticity: a randomized trial. PM R. 2018;10(7):693–03
  9. Allergan, Data on file. 023: BOTOX®

Please refer to the BOTOX® Summary of Product Characteristics for further information on adverse events, contraindications and special warnings and precautions for use. The BOTOX® Summary of Product Characteristics can be found here

By clicking the link above you will leave the AbbVie Pro website and be taken to the eMC PI portal website.

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or via the MHRA Yellow Card app, available in the Google Play or Apple App Stores.

Adverse events should also be reported to AbbVie on GBPV@abbvie.com

 

Date of preparation: June 2025. UK-BTX-250065.