Completed

FingoHRVEffect of Fingolimod on the Cardiac Autonomic Regulation in Patients With Multiple Sclerosis

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

From 18 to 65 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: December 2012
See protocol details

Summary

Principal SponsorKuopio University Hospital
Last updated: May 8, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2012

Actual date on which the first participant was enrolled.

The study will include 30 relapse-remitting multiple sclerosis patients. Assessments of heart rate variability and myocardial ventricular repolarisation pattern will be done 1) before fingolimod, 2) first day of fingolimod 3) after 3 months use and 4) after 12 months use of fingolimod.

NCT01704183
Principal SponsorKuopio University Hospital
Last updated: May 8, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

27 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate
Age 18 - 65 years
The written informed consent has given
Understands the proposed research and actions to be taken
clinical indication to fingolimod-treatment
4 exclusion criteria prevent from participating
Contraindication to the use of fingolimod
No clinical indication to the use of fingolimod
Patient refuses
Patient takes or has taken part in other clinical drug trial during the last month

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Neuro Center, Kuopio University Hospital

Kuopio, FinlandOpen Neuro Center, Kuopio University Hospital in Google Maps

Department of Neurology, Mikkeli Central Hospital

Mikkeli, Finland
Completed2 Study Centers