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 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT03164018
Eligibility Criteria:
Inclusion Criteria:
* Adult patient (≥18 years old) with MS.
* Patient receiving Fampyra® for walking disability (EDSS 4-7).
* Patient receiving stable doses of any Disease Modifying Treatment (DMT) for at least 3 months prior to study entry.
* Patients will receive Fampyra® in line with the approved Summary of Product Characteristics (SmPC).
* Patients for whom the decision to prescribe therapy with Fampyra according to the locally approved product's summary of product characteristics (SmPC) has already been taken prior to their enrollment in the study and is clearly separated from the physician's decision to include the patient in the current study.
* Patients must have signed an informed consent document.
* Patients must be able to read, understand and complete the study specific questionnaires.
Exclusion Criteria:
* Pregnant or lactating woman.
* Patient with prior history or current presentation of seizure.
* Patient with mild, moderate or severe renal impairment (creatinine clearance \< 80 ml/min).
* Concurrent treatment with other medicinal products containing fampridine (4-aminopyridine).
* Concomitant treatment with medicinal products that are inhibitors of Organic Transporter 2 (OCT2), e.g., cimetidine.
* Patients who have received more than 1 dose of fampridine at the time of enrollment into the study.
* Patients that meet any of the contraindications to the administration of the study drug according to the approved SmPC.
* Patients who currently receive treatment with any investigational drug/device/intervention or have received any investigational product within 1 month or 5 half-lives of the investigational agent (whichever is longer) before the commencement of therapy with fampridine
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03164018
Study Brief:
Protocol Section:
NCT03164018