" Treating MS Patients With Lower Extremity Spasticity Using Dysport"

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03585569
• Date of registration: 16/03/2018
• Prospective Registration: Yes
• Primary sponsor: Neurology Center of New England P.C.
• Public title: " Treating MS Patients With Lower Extremity Spasticity Using Dysport"
• Scientific title: A Prospective, Open Label, Single Center Study of Patients With Multiple Sclerosis With Lower Extremity Spasticity Who Are Treated With Dysport
• Date of first enrolment: May 1, 2018
• Target sample size: 30
• Recruitment status: Unknown status
• URL: https://clinicaltrials.gov/show/NCT03585569
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: Sarah Cardoso

• Name: Sarah Cardoso

• Name: Salvatore Q Napoli, MD
• Affiliation: Neurology Center of New England P.C.

Key inclusion & exclusion criteria

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.



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Spasticity, Muscle

Intervention(s)

Biological: Abobotulinumtoxin A

Primary Outcome(s)

Using 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. [Time Frame: 20 weeks]

Secondary Outcome(s)

Mean change from baseline in Modified Ashworth Scale (MAS) [Time Frame: Baseline week 12, week 16, and week 20]

Secondary ID(s)

SAIRB-17-0093

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ipsen