" Treating MS Patients With Lower Extremity Spasticity Using Dysport"

NCT03585569 | Unknown Phase 3 FDA Drug

• 1 other identifier: SAIRB-17-0093
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Using Dysport® (abobotulinumtoxin A) to treat patients diagnosed with Multiple Sclerosis with lower extremity spasticity .

  20 weeks

Secondary Outcomes (1)

• Mean change from baseline in Modified Ashworth Scale (MAS)

  Baseline week 12, week 16, and week 20

Other Outcomes (9)

• 12 item Multiple Sclerosis Walking scale (MSWS-12) Improvement

  Baseline weeks 12, 16, and 20

• Improvement of (MSIS-29) Multiple Sclerosis Impact Scale

  Baseline weeks 12,16 and 20

• Improvement of Pain Scale

  Baseline weeks 12,16 and 20

Interventions

Abobotulinumtoxin A BIOLOGICAL

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

Also known as: Dysport

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female with confirmed diagnosis of MS1 over 18 years of age.
• 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.
• 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.
• 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.
• 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.
• Penn spasm frequency scale at baseline greater than 2.
• Functional outcomes such as walking speed T25FW baseline walking speed greater than 0.8.
• Subjects that have agreed to participate and have signed an informed consent form.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neurology Center of New England P.C.: lead
• Ipsen: collaborator

Study Sites (1)

Neurology Center of New England P.C.

Foxborough, Massachusetts, 02035, United States

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis; Muscle Spasticity

Interventions

abobotulinumtoxinA

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Salvatore Q Napoli, MD

  Neurology Center of New England P.C.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Cardoso

CONTACT

781-551-5812; sarahc@myneurodr.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2018
• First Posted: July 13, 2018
• Study Start: May 1, 2018
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2020
• Last Updated: July 13, 2018

Record last verified: 2018-07

Locations

US (1)