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 @ 9:46 PM
Ignite Modification Date:
2025-12-24 @ 9:46 PM
NCT ID:
NCT02219932
Eligibility Criteria:
Key Inclusion Criteria:
* Must have a diagnosis of primary-progressive, secondary-progressive, progressive-relapsing, or relapsing-remitting MS per revised McDonald Committee criteria \[McDonald 2001; Polman 2005\] as defined by Lublin and Reingold \[Lublin and Reingold 1996\] of at least 3 months duration
* Must have an Expanded Disability Status Scale (EDSS) score of 4 to 7, inclusive
* Must have walking impairment, as deemed by the Investigator
Key Exclusion Criteria:
* History of human immunodeficiency virus (HIV)
* Presence of acute or chronic hepatitis. Subjects who have evidence of prior hepatitis infection that has been serologically confirmed as resolved are not excluded from study participation
* Known allergy to fampridine, pyridine-containing substances, or any of the inactive ingredients in the prolonged-release fampridine tablet
* Creatinine clearance (CrCl) of \<80 mL/min
* History of malignant disease
* Presence of pulmonary disease
* A body mass index (BMI) ≥40 (BMI formula: BMI = mass \[kg\]/\[height(m)\]2)
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02219932
Study Brief:
Protocol Section:
NCT02219932