Fampyra and T cell Immunity in Multiple Sclerosis; a study of the Fampyra induced immunomodulatory T cell responses in MS
Phase 1
- Conditions
- Multiple SclerosisMedDRA version: 14.1Level: LLTClassification code 10039720Term: Sclerosis multipleSystem Organ Class: 100000004852Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2013-001409-10-DK
- Lead Sponsor
- Odense University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
MS patients treated with fampridine for at least one year.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
Exclusion Criteria
None, if fulfilling the inclusion criteria.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare ex vivo T cell functions in 20 MS patients on fampridine for >1 year to 20 clinically matched MS patients without fampridine treatment. <br><br>;Secondary Objective: Not applicable;Primary end point(s): Frequency of T cell subsets (CD4, CD8, Treg), frequency of TEM (CCR7-CD62LlowCD45RA-) and TCM (CCR7+CD62LhiCD45RA-), activation state of these five T cell subsets (CD25, HLA-DR, CD69), and their intracellular cytokine expression (IL-2, IFN-?, IL-4, IL-5, IL-10, IL-17) ;Timepoint(s) of evaluation of this end point: This is merely a cross-sectional study. Blood samples will be drawn on one day from subjects and controls and will be evaluated here atfter.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Not applicaple;Timepoint(s) of evaluation of this end point: Not applicable