Effect of fingolimod on cardiac autonomic regulation in MS-patients

Phase 1

• Conditions: Multiple sclerosis; MedDRA version: 14.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2012-002694-66-FI
• Lead Sponsor: Sakari Simula

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-10-08
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

- Age 18 – 65 years
- Doctor considers to initiate fingolimod-treatment on clinical grounds

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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- No clinical indication to fingolimod
- Contraindication to fingolimod
- Patient takes or has taken part in other clinical drug trial during the last month

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate whether fingolimod has an effect on the heart rate variability or myocardial ventricular repolarisation in patients with multiple sclerosis?;Secondary Objective: To evaluate whether possible changes in heart rate variability or myocardial ventricular repolarisation are transient or constant?;Primary end point(s): Change in the heart rate variability and myocardial ventricular repolarisation properties;Timepoint(s) of evaluation of this end point: First day of fingolimod use, 3 months and 12 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): None;Timepoint(s) of evaluation of this end point: .