Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-24 @ 10:47 PM
NCT ID:
NCT03585569
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.
\-
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.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT03585569
Study Brief:
Protocol Section:
NCT03585569