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 @ 5:09 PM
Ignite Modification Date:
2025-12-24 @ 5:09 PM
NCT ID:
NCT02208050
Eligibility Criteria:
Inclusion Criteria:
* Subjects must be able and willing to give written informed consent and to comply with the requirements of this study protocol
* Subjects must be diagnosed with clinically definite SPMS or PPMS and be judged to be in generally good health by the investigator based upon the results of the medical history, laboratory tests (liver and renal function), physical examination, 12-lead electrocardiogram performed during Screening
* Subjects must be Male or female aged 18-70 at baseline
* Kurtzke EDSS scores in the range 4.0 to 7.0 inclusive
* Evidence of significant upper limb dysfunction as defined by a 9HPT of 15 - 90 seconds (dominant or non-dominant hand)
* Female subjects with reproductive capabilities must have a negative serum pregnancy test at baseline and agree to using an acceptable form of contraception for the duration of the study (barrier, coil or oral contraceptives only).
Exclusion Criteria:
* Allergy/sensitivity to study medications or their ingredients
* Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study.
* Subjects unable to provide written informed consent
* Subjects with a history of epilepsy or previous seizures (including provoked seizures).
* Subjects who have a history of drug or alcohol use that, in the opinion of the investigator, would interfere with adherence to study requirements.
* Subjects with an AST or ALT ≥ 3 x ULN on liver function tests
* Subjects have clinically significant ECG findings as judged by the investigator, in particular evidence of a cardiac conduction defect.
* Significant upper or lower limb arthritis as considered by the investigator to interfere with study assessments.
* Significant cognitive impairment as considered by the investigator to interfere with study assessments
* Subjects with clinically significant upper limb ataxia considered by the investigator to interfere with ability to complete study outcome measures.
* Patients with mild, moderate or severe renal impairment (creatinine clearance\<80ml/min) measured by 24-hour urine collection or estimated by the Cockcroft and Gault formula
* Subjects concomitantly using medicinal products that are inhibitors of Organic Cation Transporter 2 (OCT2) for example cimetidine
* Concurrent treatment with other medicinal products containing fampridine (4- aminopyridine)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02208050
Study Brief:
Protocol Section:
NCT02208050