" Treating MS Patients With Lower Extremity Spasticity Using Dysport"

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.