Loosened the hold of lower limb spasticity for 4 to 5.5 months* in most patients1

*The majority of patients in the clinical study were retreated between 16 and 22 weeks; however, some patients had a longer duration of response. The degree and pattern of muscle spasticity and overall clinical benefit at the time of re-injection may necessitate alterations in the dose of Dysport and the muscles to be injected.¹

Results from a clinical trial specifically for pediatric patients with lower limb spasticity 2 years of age and older

Dysport was evaluated with meaningful clinical endpoints.

Co-primary efficacy endpoints1,2

Reduction in ankle plantar flexor muscle tone

at Week 4, as measured by the mean change from baseline in Modified Ashworth Scale (MAS)

Improvement in response to treatment

at Week 4, as measured by mean Physician’s Global Assessment (PGA) of response to treatment score


Study design1,2 


study design visual of intent-to-treat population of patients, radomized into placebo or Dysport 10 or 15 units/kg/leg for 4 weeks at primary endpoint and 12 weeks at follow-up


*The ITT population (N=235) included all randomized subjects who received at least one injection of study treatment and who had a MAS score in the gastroc-soleus muscle complex assessed both at baseline and at Week 4.

  • A multicenter, prospective, double-blind, randomized, placebo-controlled study assessing Dysport in pediatric patients 2 to 17 years of age with lower limb spasticity because of cerebral palsy causing dynamic equinus foot deformity
  • In the pivotal clinical trial, doses of Dysport 10 Units/kg/leg or Dysport 15 Units/kg/leg or placebo were injected intramuscularly into the gastrocnemius and soleus muscles1
  • The 12-week follow-up visit included assessment for retreatment eligibility
  • Pediatric patients who remained in the study after Week 12 were permitted additional discretionary follow-up visits at Week 16, Week 22, and Week 28 to assess eligibility for retreatment5

Endpoints evaluated using validated scales

The MAS is an updated version of the Ashworth Scale used to measure muscle tone and includes an additional scoring component to measure resistance during movement

The PGA is a global assessment of a physician’s impression of a patient’s response to treatment2  

Patient characteristics (ITT population)²

GMFCS (Gross Motor Function Classification System) levels studied7:

I – Walks without limitations

II – Walks with limitations

III – Walks using a hand-held mobility device

Patient characteristics

Dysport significantly reduced muscle tone at Week 41

Reduction in ankle plantar flexor muscle tone vs placebo as assessed by the mean change in Modified Ashworth Scale (MAS) at Week 4


  • MAS score at baseline (mean [SD]): placebo, 3.2 (+/-0.4); Dysport 10 Units/kg/leg, 3.1 (+/-0.3); Dysport 15 Units/kg/leg, 3.1 (+/-0.3)1,2
  • The most frequently reported adverse reactions (≥10%) were: nasopharyngitis, cough, and pyrexia

Muscle tone reduction

Physicians noted a significant response to treatment in patients receiving Dysport at Week 41

Response to treatment vs placebo as assessed by the mean Physician’s Global Assessment (PGA) at Week 41

  • Time to retreatment was not the primary endpoint
  • PGA and MAS were assessed by separate investigators2
  • The most frequently reported adverse reactions (≥10%) were: upper respiratory tract infection, nasopharyngitis, influenza, pharyngitis, cough, and pyrexia

Response to treatment

Discover time between treatment visits

However, some patients had a longer duration of response1

*Patients who remained in the study after Week 12 were permitted additional discretionary follow-up visits at Week 16, Week 22, and Week 28 to assess eligibility for retreatment.7

  • The degree and pattern of muscle spasticity and the overall clinical benefit at the time of reinjection may necessitate alterations in the dose of Dysport (abobotulinumtoxinA) and muscles to be injected1
  • Repeat Dysport treatment should be administered when the effect of a previous injection has diminished but no sooner than 12 weeks after the previous injection1
  • Eligibility for retreatment was assessed by the investigator at every visit from Week 12 onwards

Time to treatment

Register for Dysport Doctor Locator when you sign up for C.L.I.M.B.® training:

The C.L.I.M.B.® program includes comprehensive Dysport injection training:

• 1:1 in-office training

• Live group training or web conference (dosing, reconstitution, and injection simulator)

• Educational videos, brochures, and information on purchasing and reimbursement

*See eligibility criteria at www.CLIMB-training.com.




Warning: Distant Spread of Toxin Effect

Postmarketing reports indicate that the effects of Dysport and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity, but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have underlying conditions that would predispose them to these symptoms. In unapproved uses and in approved indications, cases of spread of effect have been reported at doses comparable to or lower than the maximum recommended total dose.


Dysport is contraindicated in patients with known hypersensitivity to any botulinum toxin products, cow’s milk protein, components in the formulation or infection at the injection site(s). Serious hypersensitivity reactions including anaphylaxis, serum sickness, urticaria, soft tissue edema, and dyspnea have been reported. If such a reaction occurs, discontinue Dysport and institute appropriate medical therapy immediately.

Warnings and Precautions

Lack of Interchangeability Between Botulinum Toxin Products

The potency Units of Dysport are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products, and, therefore, units of biological activity of Dysport cannot be compared to or converted into units of any other botulinum toxin products assessed with any other specific assay method.

Dysphagia and Breathing Difficulties

Treatment with Dysport and other botulinum toxin products can result in swallowing or breathing difficulties. Patients with pre-existing swallowing or breathing difficulties may be more susceptible to these complications. In most cases, this is a consequence of weakening of muscles in the area of injection that are involved in breathing or swallowing. When distant side effects occur, additional respiratory muscles may be involved. Deaths as a complication of severe dysphagia have been reported after treatment with botulinum toxin. Dysphagia may persist for several weeks, and require use of a feeding tube to maintain adequate nutrition and hydration. Aspiration may result from severe dysphagia and is a particular risk when treating patients in whom swallowing or respiratory function is already compromised. Patients treated with botulinum toxin may require immediate medical attention should they develop problems with swallowing, speech, or respiratory disorders.  These reactions can occur within hours to weeks after injection with botulinum toxin.

Pre-existing Neuromuscular Disorders

Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junction disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome) should be monitored particularly closely when given botulinum toxin. Patients with neuromuscular disorders may be at increased risk of clinically significant effects including severe dysphagia and respiratory compromise from typical doses of Dysport.

Human Albumin and Transmission of Viral Diseases

This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD). There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), but if that risk actually exists, the risk of transmission would also be considered extremely remote. No cases of transmission of viral diseases, CJD, or vCJD have ever been identified for licensed albumin or albumin contained in other licensed products.

Intradermal Immune Reaction

The possibility of an immune reaction when injected intradermally is unknown. The safety of Dysport for the treatment of hyperhidrosis has not been established. Dysport is approved only for intramuscular injection.

Most Common Adverse Reactions

Adults with lower limb spasticity (≥5%): falls, muscular weakness, and pain in extremity and with upper limb spasticity (≥4%): muscular weakness.

Pediatric patients with lower limb spasticity (≥10%): nasopharyngitis, cough and pyrexia and with upper limb spasticity (≥10%): upper respiratory tract infection and pharyngitis.

Adults with cervical dystonia (≥5%): muscular weakness, dysphagia, dry mouth, injection site discomfort, fatigue, headache, musculoskeletal pain, dysphonia, injection site pain, and eye disorders.

Drug Interactions

Co-administration of Dysport and aminoglycosides or other agents interfering with neuromuscular transmission (e.g., curare-like agents), or muscle relaxants, should be observed closely because the effect of botulinum toxin may be potentiated. Use of anticholinergic drugs after administration of Dysport may potentiate systemic anticholinergic effects, such as blurred vision. The effect of administering different botulinum neurotoxins at the same time or within several months of each other is unknown. Excessive weakness may be exacerbated by another administration of botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin. Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of Dysport.

Special Populations

Use in Pregnancy

There are no adequate and well-controlled studies in pregnant women. Dysport should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Based on animal data, Dysport may cause fetal harm.

Pediatric Use

The safety and effectiveness of Dysport injected into proximal muscles of the lower limb for the treatment of spasticity in pediatric patients has not been established. Based on animal data Dysport may cause atrophy of injected and adjacent muscles; decreased bone growth, length, and mineral content; delayed sexual maturation; and decreased fertility.

Geriatric Use

In general, elderly patients should be observed to evaluate their tolerability of Dysport, due to the greater frequency of concomitant disease and other drug therapy. Subjects aged 65 years and over who were treated with Dysport for lower limb spasticity reported a greater percentage of fall and asthenia as compared to those younger (10% vs. 6% and 4% vs. 2%, respectively).

To report SUSPECTED ADVERSE REACTIONS or product complaints, contact Ipsen at 1-855-463-5127. You may also report SUSPECTED ADVERSE REACTIONS to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.


Dysport® (abobotulinumtoxinA) for injection is indicated for the treatment of:

  • Spasticity in patients 2 years of age and older
  • Cervical dystonia in adults


Please see full Prescribing Information, including Boxed Warning and Medication Guide.


  1. Dysport® (abobotulinumtoxinA) [Prescribing Information]. Cambridge, MA: Ipsen Biopharmaceuticals, Inc; July 2020.
  2. Data on file. Cambridge, MA; Ipsen Biopharmaceuticals, Inc.
  3. Esquenazi A, Alfaro A, Ayyoub Z, et al. PM R. 2017. pii: S1934-1482(16)31113-3. doi: 10.1016/j.pmrj.2017.02.014. [Epub ahead of print]. http://www.pmrjournal.org/article/S1934-1482(16)31113-3/fulltext. Accessed August 30, 2017.
  4. NeuroRehabResource.org Web site. http://www.neurorehabresource.org/Files/NRR_Differential_Diagnosis.pdf. Accessed August 30, 2017.
  5. Delgado MR, Tilton A, Russman B, et al. AbobotulinumtoxinA for equinus foot deformity in cerebral palsy: a randomized controlled trial. Pediatrics. 2016:137(2):e20152830. doi: 10.1542/peds.2015-2830.
  6. Rehabilitation Measures Database. Rehab measures: Ashworth Scale/Modified Ashworth Scale. http://www.rehabmeasures.org/Lists/RehabMeasures/PrintView.aspx?ID=902. Accessed June 15, 2016.
  7. Palisano R, Rosenbaum P, Bartlett D, Livingston M. Gross Motor Function Classification System: Expanded and Revised. https://canchild.ca/system/tenon/assets/attachments/000/000/058/original/GMFCS-ER_English.pdf. Accessed June 15, 2016.
  8. Truong D, Brodsky M, Lew M, et al; Global Dysport Cervical Dystonia Study Group. Long-term efficacy and safety of botulinum toxin type A (Dysport®) in cervical dystonia. Parkinsonism Relat Disord. 2010;16:316-323.
  9. Truong D, Duane DD, Jankovic J, et al. Efficacy and safety of botulinum type A toxin (Dysport®) in cervical dystonia: results of the first US randomized, double-blind, placebo-controlled study. Mov Disord. 2005;20:783-791.
  10. Blitzer E, Benson BE, Guss J. Botulinum Neurotoxin for Head and Neck Disorders. New York, NY. Thieme Medical Publishers, Inc. 2012.
© 2020 Ipsen Biopharmaceuticals Inc. All rights reserved. April 2020 DYS-US-004731


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