" Treating MS Patients With Lower Extremity Spasticity Using Dysport"

Last updated: July 11, 2018
Sponsor: Neurology Center of New England P.C.
Overall Status: Active - Recruiting

Phase

3

Condition

Neurologic Disorders

Memory Loss

Scar Tissue

Treatment

N/A

Clinical Study ID

NCT03585569
SAIRB-17-0093
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:Subjects who meet all of the following inclusion criteria will beeligible:

  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 withrelapsing-remitting MS, primary progressive MS, progressive relapsing MS, andsecondary progressive MS based on clinical history, physical exam, current or previousbrain or spine MRI, CSF analysis will be used to specify the class of MS of thepatient.

  3. Patients with no prior exposure to any commercial Botulinum toxin or patients thathave had previous exposure to commercial Botulimun toxin no less than four monthsafter last injection.

  4. Naïve patients having a MAS score ≥1 at baseline in any of the following musclessoleus, gastrocnemius, lateral gastrocnemius, medial gastrocnemius, flexor digitorumlongus, 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 inany of the following US Dysport label muscles such as the soleus, gastrocnemius,lateral gastrocnemius, medial gastrocnemius, flexor digitorum longus, flexor halluceslongus, or muscles beyond the label such as the rectus femorus, vastus lateralis,lateral hamstrings, medial hamstrings, adductor magnus, adductor longus, adductorbrevis, 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

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 ofscreening.

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

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

Study Design

Total Participants: 30
Study Start date:
May 01, 2018
Estimated Completion Date:
May 31, 2020

Study Description

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,

  • 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

Connect with a study center

  • Neurology Center of New England P.C.

    Foxboro, Massachusetts 02035
    United States

    Active - Recruiting

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