The purpose of this study is to determine whether Dysport® (abobotulinumtoxinA) injections for lower extremity spasticity showed a significant reduction of lower extremity spasticity after being injected with Dysport® (abobotulinumtoxinA) in patients with MS.
Primary Objective To evaluate the effect of Dysport® (abobotulinumtoxin A) on lower extremity spasticity (soleus, gastrocnemius, lateral gastrocnemius, medial gastrocnemius, flexor digitorum longus, flexor halluces longus, rectus femorus, vastus lateralis, lateral hamstrings, medial hamstrings, adductor magnus, adductor longus, adductor brevis, triceps surae, tibialis posterior or anterior tibialis). Other Objectives * To explore the effect of Dysport® on improvement in walking ability in patients with MS * To explore the effect of Dysport® on quality of (QoL) in patients with MS. Primary Endpoint Absolute change from baseline in Modified Ashworth Scale (MAS) through 20 weeks of treatment. Other Endpoints * Change from baseline in MAS scores at Weeks 12, 16, and 20. * Change from baseline on QoL based on patient reported outcome (PRO) measures on the MSWS-12, MSIS 29, pain scales (0-10 pain scale) the MSSS-88, and the Penn spasm frequency scale through 20 weeks of treatment. * Change from baseline on the time 25 foot walk (T25FW) test with timed up and go (TUG) through 20 weeks of treatment. * Change from baseline on expanded disability status scale (EDSS) score at Weeks 12, 16, 20. * Change from baseline in speed, cadence, general symmetry, propulsion, stride length, T25FW, TUG using GWALK device for gait assessments through 20 weeks. * Adverse events over 20 weeks * Serious adverse events over 20 weeks
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Treating Patients with Multiple Sclerosis with lower extremity spasticity using Dysport (Abobotulinumtoxin A)
Neurology Center of New England P.C.
Foxborough, Massachusetts, United States
RECRUITINGUsing Dysport to treat lower extremity spasticty in patients diagnosed with Multiple Sclerosis. Improved walking ability and quality of life in 28 patients based on quality of life assessments and patient reported outcomes.
Using Dysport® (abobotulinumtoxin A) to treat patients diagnosed with Multiple Sclerosis with lower extremity spasticity .
Time frame: 20 weeks
Mean change from baseline in Modified Ashworth Scale (MAS)
Mean change from baseline in Modified Ashworth Scale (MAS).. The Modified Ashworth Scale issued to grade spasticity. This scale measures the presence of velocity-dependent resistance on a 0 to 4 scale, with zero representing normal muscle tone, and four representing a limb that is fixed in flexion or extension
Time frame: Baseline week 12, week 16, and week 20
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