This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Dysport® Adult Lower Limb Spasticity Study

This study has been completed.
Information provided by (Responsible Party):
Ipsen 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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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 ]

Secondary Outcome Measures:
  • Physician's global assessment (PGA) of the treatment response [ Time Frame: Week 4 ]
  • Walking speed [ Time Frame: Change from baseline at week 4 ]

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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01249404

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

Responsible Party: Ipsen Identifier: NCT01249404     History of Changes
Other Study ID Numbers: Y-55-52120-140
2009-015868-34 ( EudraCT Number )
Study First Received: November 25, 2010
Last Updated: May 26, 2015

Additional relevant MeSH terms:
Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents processed this record on September 19, 2017