Recruiting
Phase 3

Dysport

Sponsor:

Neurology Center of New England P.C.

Code:

NCT03585569

Conditions

Multiple Sclerosis

Spasticity, Muscle

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Abobotulinumtoxin A

Study Details

Brief 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.

Conditions

Multiple Sclerosis

Spasticity, Muscle

Study ID

NCT03585569

Start date

May 1, 2018

Status verified date

Jul, 2018

Completion date

May, 2020

Anticipated

Primary completion date

May, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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.

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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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Abobotulinumtoxin A

Treating Patients with Multiple Sclerosis with lower extremity spasticity using Dysport (Abobotulinumtoxin A)

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Locations

Neurology Center of New England P.C.

Recruiting

Foxboro, Massachusetts, United States, 02035

Contacts

Principal Investigator:

Salvatore Napoli, MD

More Information

Sponsor

Neurology Center of New England P.C.

Last update posted

Jul 13, 2018

Last verified

Jul, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Neurology Center of New England P.C. on 2018-07-13.