Dysport® Adult Lower Limb Spasticity Study

Completed · Phase 3 · Has a placebo group

Conditions studied: Leg Spasticity

In brief

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.

Key facts

Study ID

NCT01249404

Run by

Ipsen

People needed

388

Starts

2011-03-01

Expected to finish

2014-05-01

Last updated by the study team

2022-09-28

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Rancho Los Amigos — Downey, California, United States
• Pacific Neuroscience Medical Group — Oxnard, California, United States
• Associated Neurologists of Southern CT, PC — Fairfield, Connecticut, United States
• Parkinson's Disease & Movement Disorders Center of Boca Raton — Boca Raton, Florida, United States
• Design Neuroscience — Miami Gardens, Florida, United States
• Mount Sinai School of Medicine — New York, New York, United States
• Weill Cornell Medical College — New York, New York, United States
• University of North Carolina - Chapel Hill — Chapel Hill, North Carolina, United States
• Wake Forest University Baptist Medical Center — Winston-Salem, North Carolina, United States
• MossRehab & Albert Einstein — Elkins Park, Pennsylvania, United States
• Vanderbilt University — Nashville, Tennessee, United States
• The University of Texas Southwestern Medical Center at Dallas — Dallas, Texas, United States
• University of North Texas HSC at Ben Hogan Center — Fort Worth, Texas, United States
• Neurorehabilitation Specialist — Houston, Texas, United States
• University of Texas - Houston — Houston, Texas, United States
• University of Utah School of Medicine — Salt Lake City, Utah, United States
• Epworth HealthCare — Richmond, Victoria, Australia
• Caulfield Hospital — Caulfield, Australia
• Saint Vincent's Hospital — Darlinghurst, Australia
• Saint Vincent's Hospital — Fitzroy, Australia
• St George Hospital — Kogarah, Australia
• Royal Melbourne Hospital — Parkville, Australia
• Epworth Healthcare — Richmond, Australia
• Westmead Hospital — Westmead, Australia
• Mayo Clinic Arizona — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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