Clinical trial NCT03585569: " Treating MS Patients With Lower Extremity Spasticity Using Dysport"
Official title: A Prospective, Open Label, Single Center Study of Patients With Multiple Sclerosis With Lower Extremity Spasticity Who Are Treated With Dysport
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Multiple Sclerosis
Spasticity, Muscle
Lead sponsor: Neurology Center of New England P.C.
Sponsor class: OTHER
Collaborators: name: Ipsen
First posted: 2018-07-13
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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, 20.
* 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

Eligibility 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.

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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.

Primary outcomes:
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.
timeFrame: 20 weeks
Secondary outcomes:
measure: Mean change from baseline in Modified Ashworth Scale (MAS)
timeFrame: Baseline week 12, week 16, and week 20
Other outcomes:
measure: 12 item Multiple Sclerosis Walking scale (MSWS-12) Improvement
timeFrame: Baseline weeks 12, 16, and 20
measure: Improvement of (MSIS-29) Multiple Sclerosis Impact Scale
timeFrame: Baseline weeks 12,16 and 20
measure: Improvement of Pain Scale
timeFrame: Baseline weeks 12,16 and 20
measure: Improvement of (MSSS-88) Multiple Sclerosis Spasticity Scale
timeFrame: Baseline weeks 12,16 and 20
measure: Improvement of the Penn Spasm frequency scale
timeFrame: Baseline weeks 12,16 and 20
measure: Improvement from baseline on the Timed 25 foot walk (T25FW)
timeFrame: Baseline weeks 12,16 and 20
measure: Improvement of Timed up and Go
timeFrame: Baseline weeks 12,16 and 20
measure: Improvement on the (EDSS) score
timeFrame: Baseline weeks 12,16 and 20
measure: Walking improvement
timeFrame: Baseline weeks 12,16 and week 20
Locations:
city: Foxboro
country: United States
facility: Neurology Center of New England P.C.
state: Massachusetts
Study officials:
affiliation: Neurology Center of New England P.C.
name: Salvatore Q Napoli, MD
role: PRINCIPAL_INVESTIGATOR
References: