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

• Register: EUCTR
• Last refreshed on: 8 August 2022
• Main ID: EUCTR2013-001409-10-DK
• Date of registration: 06/08/2013
• Prospective Registration: Yes
• Primary sponsor: Odense University Hospital
• Public title: Fampyra and T cell Immunity in Multiple Sclerosis; a study of the Fampyra induced immunomodulatory T cell responses in MS
• Scientific title: FATIMS - Fampyra and T cell Immunity in Multiple Sclerosis; a study of the Fampyra induced immunomodulatory T cell responses in MS - FATIMS
• Date of first enrolment: 08/08/2013
• Target sample size: 40
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-001409-10
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: yes; Other specify the comparator: Non-treatment
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Denmark

Contacts

• Name: Henrik Boye Jensen
• Affiliation: Odense University Hospital

• Name: Henrik Boye Jensen
• Affiliation: Odense University Hospital

Key inclusion & exclusion 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:
None, if fulfilling the inclusion criteria.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

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 number: 10-

Primary Outcome(s)

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.

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 Objective: Not applicable

Secondary Outcome(s)

Secondary end point(s): Not applicaple

Timepoint(s) of evaluation of this end point: Not applicable

Secondary ID(s)

FATIMS1.0

Source(s) of Monetary Support

Odense University Hospital

Ethics review

Status: Approved
Approval date: 03/07/2013
Contact:

Results

• Results available: Yes
• Date Posted: 10/10/2021
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2013-001409-10/results