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 @ 2:27 AM
Ignite Modification Date:
2025-12-25 @ 2:27 AM
NCT ID:
NCT02146534
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of McDonald criteria MS of all types and of age 18 and older.
* Subjects who meet the prescribing criteria for Fampyra as per product monograph.
* Therapeutic stability (MS and symptomatic treatment) for 3 months prior to screening and for the duration of the study.
* Pyramidal system functional assessment score of 2 or greater and the ability to complete all the assessments with or without aids.
* Female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.
Exclusion Criteria:
* Any contraindication to receiving fampridine as per product monograph including but not limited to prior history of epilepsy, renal dysfunction (abnormal serum creatinine), concomitant treatment with cimetidine or quinidine.
* Ongoing treatment with fampridine or prior history of fampridine intolerance or ineffectiveness
* Any other condition that would preclude them from undergoing the NeuroGym training.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02146534
Study Brief:
Protocol Section:
NCT02146534