" Treating MS Patients With Lower Extremity Spasticity Using Dysport"
" Treating MS Patients With Lower Extremity Spasticity Using Dysport"
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
Inclusion Criteria:Subjects who meet all of the following inclusion criteria will be
 eligible:

 1. Male or female with confirmed diagnosis of MS1 over 18 years of age.

 2. Patients with a clinically definite diagnosis of MS including patients with
 relapsing-remitting MS, primary progressive MS, progressive relapsing MS, and
 secondary progressive MS based on clinical history, physical exam, current or previous
 brain or spine MRI, CSF analysis will be used to specify the class of MS of the
 patient.

 3. Patients with no prior exposure to any commercial Botulinum toxin or patients that
 have had previous exposure to commercial Botulimun toxin no less than four months
 after last injection.

 4. Naïve patients having a MAS score ≥1 at baseline in any of the following muscles
 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.

 5. Patients with prior exposure to commercial Botulinum having a MAS ≥1 at baseline in
 any of the following US Dysport label muscles such as the soleus, gastrocnemius,
 lateral gastrocnemius, medial gastrocnemius, flexor digitorum longus, flexor halluces
 longus, or muscles beyond the label such as the rectus femorus, vastus lateralis,
 lateral hamstrings, medial hamstrings, adductor magnus, adductor longus, adductor
 brevis, tibialis posterior EDSS score less than 7.0.

 6. Penn spasm frequency scale at baseline greater than 2.

 7. Functional outcomes such as walking speed T25FW baseline walking speed greater than
 0.8.

 8. Subjects that have agreed to participate and have signed an informed consent form.

 -

 Exclusion Criteria:

 -  Subjects who meet any of the following exclusion criteria will not be eligible:

 1. Subjects having experienced a relapse within the previous 30 days.

 2. Recently initiated treatment on antispasmodic therapy or Ampyra within 30 days of
 screening.

 3. Subjects that have not maintained a steady dose of baclofen or other
 antispasmodics in the previous 30 days will be excluded.

 4. Pregnant or women who intend to become pregnant or breastfeeding women. Women of
 child bearing potential are required to use oral contraceptives, condoms,
 intrauterine device (IUD) diaphragm, spermicide, sexual abstinence or
 vasectomized partner. Female patients using contraception should continue to use
 contraception 3- 4 months post injection. Women of childbearing potential are
 defined as any female who has experienced menarche and who is NOT permanently
 sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months
 with no menses without an alternative medical cause.