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:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-25 @ 2:30 AM
NCT ID:
NCT06171334
Eligibility Criteria:
Inclusion Criteria:
Written informed consent obtained
* Men and women aged of 18 and 65 years inclusive
* With Primary Progressive Multiple Sclerosis, according to current diagnostic criteria
* Screening Expanded Disability Status Scale score between 4.0 and 6.5 inclusive
* Screening timed 25-foot walk (average of two trials) of 5.5 seconds or more
Exclusion Criteria:
Patients whose screening MRI scan shows gadolinium enhancing lesions
* Patients with known renal insufficiency
* Patients with known significant hepatic impairment
* Patients with known allergy to gadolinium MRI contrast agent
* Patients currently using immune-modulators such as ocrelizumab or hydroxychloroquine
* Patients currently using therapeutic anticoagulation (blood thinners, such as warfarin, apixaban, rivaroxaban, dabigatran, enoxaparin)
* Patients currently using Fampridine or 4-aminopyridine
* Patients planning to start Fampridine or 4-aminopyridine during the study period
* Patients planning to start Baclofen or Tizanidine during the duration of the study
* Patients who increase the dose of Baclofen or Tizanidine during the study period
* Patients who receive treatment with Botulinum toxin in the leg muscles during the study period
* Patients who are unable or unwilling to undergo gadolinium enhanced MRI scans
* Patients with known history of thrombotic events in the upper extremities
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06171334
Study Brief:
Protocol Section:
NCT06171334