" Treating MS Patients With Lower Extremity Spasticity Using Dysport"

Status unconfirmed · Phase 3

Conditions studied: Multiple Sclerosis, Spasticity, Muscle

In brief

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.

Key facts

Study ID

NCT03585569

Run by

Neurology Center of New England P.C.

People needed

30

Starts

2018-05-01

Expected to finish

2020-05-01

Last updated by the study team

2018-07-13

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Subjects who meet any of the following exclusion criteria will not be eligible:
• Subjects having experienced a relapse within the previous 30 days.
• Recently initiated treatment on antispasmodic therapy or Ampyra within 30 days of screening.
• Subjects that have not maintained a steady dose of baclofen or other antispasmodics in the previous 30 days will be excluded.
• 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.

Where it is running

• Neurology Center of New England P.C. — Foxborough, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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