Fampyra and T cell Immunity in Multiple Sclerosis; a study of the Fampyra induced immunomodulatory T cell responses in MS

FATIMS - Fampyra and T cell Immunity in Multiple Sclerosis; a study of the Fampyra induced immunomodulatory T cell responses in MS - FATIMS

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001409-10-DK

Enrollment

Registered

2013-08-06

Start date

2013-08-08

Completion date

Unknown

Last updated

2022-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis MedDRA version: 14.1 Level: LLT Classification code 10039720 Term: Sclerosis multiple System Organ Class: 100000004852

Interventions

Trade Name: Fampyra Product Name: Fampyra Pharmaceutical Form: Tablet INN or Proposed INN: FAMPRIDINE CAS Number: 504-24-5 Concentration unit: mg milligram(s) Concentration type: equal Concentration n

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: None, if fulfilling the inclusion criteria.

Design outcomes

Primary

Measure	Time frame
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. ;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.	—

Measure

Time frame

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. ;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

Measure	Time frame
Secondary end point(s): Not applicaple;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Denmark

Contacts

Public ContactHenrik Boye Jensen

Odense University Hospital

henrik.boye.jensen@rsyd.dk+4565412482

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026