Phase
Condition
Neurologic Disorders
Memory Loss
Scar Tissue
Treatment
N/AClinical Study ID
All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:Subjects who meet all of the following inclusion criteria will beeligible:
Male or female with confirmed diagnosis of MS1 over 18 years of age.
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.
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.
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.
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.
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.
Exclusion
Exclusion Criteria:
- 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 ofscreening.
Subjects that have not maintained a steady dose of baclofen or otherantispasmodics in the previous 30 days will be excluded.
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
Study Description
Connect with a study center
Neurology Center of New England P.C.
Foxboro, Massachusetts 02035
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.