Dysport® Adult Lower Limb Spasticity Study

Phase 3

Completed

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Dysport® 1000 U, IM	Botulinum toxin type A	1000 U, I.M. (in the muscle), on day 1 (single treatment cycle)
Dysport® 1500 U, IM	Botulinum toxin type A	1500 U, I.M., on day 1 (single treatment cycle)
Placebo	Placebo	I.M., on day 1 (single treatment cycle)

Primary Outcome Measures

Name	Time	Method
Least Squares Mean Change From Baseline to Week 4 in the MAS Score in the Gastrocnemius-soleus Complex (GSC) (Knee Extended)	Baseline and Week 4	Muscle tone in the treated limb was assessed by MAS in the GSC (with the knee extended) at baseline, at Weeks 1, 4 and 12, at discretionary visits at Weeks 16, 20 and 24, and at end of study. The MAS consists of 6 grades: 0 (no increase in muscle tone), 1 (slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion (ROM)), 1+ (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM), 2 (more marked increase in muscle tone), 3 (considerable increase in muscle tone) or 4 (affected part(s) rigid in flexion or extension), and can be applied to muscles of both the upper and lower limbs. The least squares mean change from baseline at Week 4 is reported.

Secondary Outcome Measures

Name	Time	Method
Physician's Global Assesment (PGA) of Treatment Response at Week 4	At Week 4	An assessment of overall treatment response was conducted at Weeks 4 and 12, and discretionary visits at Weeks 16, 20 and 24 and at end of study by an investigator who had not assessed the MAS. The investigator rated the response to treatment in the subject's lower limb after injection of Dysport® relative to the status at the baseline. Answers were made on a 9 point rating scale: -4=markedly worse, -3=much worse, -2=worse, -1=slightly worse, 0=no change, +1=slightly improved, +2=improved, +3=much improved, +4=markedly improved. The mean PGA score at Week 4 is reported.
Least Squares Mean Change From Baseline to Week 4 in Comfortable Barefoot Walking Speed	Baseline and Week 4	Comfortable walking speed was assessed as a measure of functional ability and gait over 10 metres. Evaluations were made barefoot, without walking aids, at baseline and Weeks 1, 4 and 12 and discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Week 4 is reported.

Locations (61): Mayo Clinic Arizona
🇺🇸
Scottsdale, Arizona, United States
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
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Mayo Clinic Arizona
🇺🇸Scottsdale, Arizona, United States