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 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT02143167
Eligibility Criteria:
Inclusion Criteria:
* Patients with relapsing remitting multiple sclerosis (RRMS), secondary progressive multiple sclerosis (SPMS) or primary progressive multiple sclerosis (PPMS) fulfilling the McDonald criteria
* Expandend Disability Status Scale (EDSS) 3-6.5
* Pyramidal Functional Score ≥ 2
* Participants must be able to transport self to gym and to the University of Southern Denmark
* Participants must be able to complete T25FW and SSST
* Fertile female participants are obliged to use hormonal contraceptive measures
Exclusion Criteria:
* History of epileptic seizures
* MS relapse or change in disease modifying treatment (DMT) within 60 days
* Cancer within five years
* Blood pressure ≥ 160/100
* Severe arrhythmia or ischaemic heart disease or unexplained abnormal cardiac auscultation
* ≥ ALT 90 U/l, ≥ BSP 210 U/l, ≥ γ-GT 230 U/l
* GFR \< 80 ml/min.
* History of severe pulmonary disease or unexplained abnormal pulmonary auscultation
* Pregnancy
* Breastfeeding
* Allergy to substances contained in prolonged release Fampridine tablets
* Concomitant treatment with carvedilol, propranolol or metformin.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02143167
Study Brief:
Protocol Section:
NCT02143167