Dysport® Adult Lower Limb Spasticity Study

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: November 25, 2010
Last updated: May 26, 2015
Last verified: May 2015
The purpose of this research study is to assess the efficacy of Dysport compared to placebo in improving muscle tone in hemiparetic subjects with lower limb spasticity due to stroke or traumatic brain injury.

Condition Intervention Phase
Leg Spasticity
Drug: Botulinum type A toxin (Dysport®)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Multicentre, Double-blind, Prospective, Randomized, Placebo-controlled Study, Assessing the Efficacy and Safety of Dysport® Used for the Treatment of Lower-limb Spasticity in Adult Subjects With Hemiparesis Due to Stroke or Traumatic Brain Injury

Resource links provided by NLM:

Further study details as provided by Ipsen:

Primary Outcome Measures:
  • Intensity of muscle tone rated by the Modified Ashworth scale [ Time Frame: Change from baseline at week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Physician's global assessment (PGA) of the treatment response [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Walking speed [ Time Frame: Change from baseline at week 4 ] [ Designated as safety issue: No ]

Enrollment: 348
Study Start Date: March 2011
Study Completion Date: May 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dysport 1000 U, IM
1000 U, I.M. (in the muscle), on day 1 (single treatment cycle)
Drug: Botulinum type A toxin (Dysport®)
I.M. injection on day 1 (single treatment cycle)
Experimental: Dysport 1500 U, IM
1500 U, I.M., on day 1 (single treatment cycle)
Drug: Botulinum type A toxin (Dysport®)
I.M. injection on day 1 (single treatment cycle)
Placebo Comparator: Placebo
I.M., on day 1 (single treatment cycle)
Drug: Placebo
I.M. injection on day 1 (single treatment cycle)


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects aged 18 to 80 years of age
  • Post stroke or brain injury
  • Intensity of muscle tone greater than or equal to 2, as measured on the Modified Ashworth Scale
  • Ambulatory patients

Exclusion Criteria:

  • Fixed contractures
  • Physiotherapy initiated less than 4 weeks before entry
  • Previous surgery or previous treatment with phenol and/or alcohol in lower limb
  • Neurological/neuromuscular disorders which may interfere with protocol evaluations
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01249404

  Show 57 Study Locations
Sponsors and Collaborators
Study Director: Ipsen Study Director Ipsen
  More Information

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT01249404     History of Changes
Other Study ID Numbers: Y-55-52120-140  2009-015868-34 
Study First Received: November 25, 2010
Last Updated: May 26, 2015
Health Authority: United States: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Russia: Ministry of Health of the Russian Federation
Belgium: Federal Agency for Medicinal Products and Health Products
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Italy: Ministry of Health
Czech Republic: State Institute for Drug Control
Slovakia: State Institute for Drug Control
Australia: Department of Health and Ageing Therapeutic Goods Administration
Portugal: INFARMED, National Authority of Medicines and Health Products, IP
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines

Additional relevant MeSH terms:
Muscle Spasticity
Muscle Hypertonia
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Manifestations
Signs and Symptoms
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Cholinergic Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neuromuscular Agents
Neurotransmitter Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 26, 2016