Evaluation of the Autonomic Nervous System During First-dosing With 0.5mg of Fingolimod (Gilenya) in Patients With Relapsing-remitting MS (ANSG)

March 30, 2016 updated by: Jochen Vehoff

Funktionelle Evaluation Des Autonomen Nervensystems im Zusammenhang Mit Der Erstmaligen Einnahme Von 0,5mg Fingolimod (Gilenya) Bei Patienten Mit schubförmig Verlaufender Multipler Sklerose

This study is designed to primarily evaluate the impact of Gilenya (Fingolimod) on the autonomic nervous system in patients being treated for the first time with Gilenya (Fingolimod). Effects on the cardiovascular system will be studied as well. The study is conducted to answer the question, if, and if yes, what impact the treatment with Gilenya (Fingolimod) has on the autonomic nervous system. To our knowledge little is known about the effects of Gilenya (Fingolimod) on the autonomic nervous system. We do know of rare, but potentially clinically and therapeutically relevant cardiovascular adverse events of Gilenya (Fingolimod). From a scientific point of view the mechanisms by which this is mediated are of interest. Maybe a better understanding of these mechanisms might even be of clinical relevance (e.g. risk stratification).

The impact of Gilenya (Fingolimod) on the autonomic nervous system is quantitavely measured, using a state-of-the-art technique. Non-invasive blood pressure measurement is performed with the Finometer Pro (Finapres Medical Systems, NL) under different paradigms (breathing at rest, deep breath, valsalva maneuver, active standing). In addition the sympathetic skin reaction is performed. The non-invasive blood pressure measurements are done by continuous, plethysmographic blood pressure measurement at the index finger, while the patient is performing the tasks mentioned above. By interpreting the blood pressure curve, heart rate and blood pressure variability are calculated. The sympathetic skin reaction consists of measuring the change of electric conductibility of the skin (palms and soles) after an electric stimulus of a peripheral nerve. These parameters allow to assess the functionality of four important autonomic functional systems (orthostasis, sympathetic adrenergic, sympathetic cholinergic, parasympathetic cholinergic). Normative data has been acquired in our lab.

Our hypothethis is, that there will be a change of heart rate variability at t4,5h compared to baseline (t0) for the parameter "RMSSD" under "normal breathing".

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • SG
      • St. Gallen, SG, Switzerland, 9000
        • Cantonal Hospital St. Gallen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • indication for treatment with Gilenya according label
  • treatment with Gilenya intended
  • no contraindications for the treatment with Gilanya
  • all safety-aspects have been fullfilled
  • age between 18 and 60 years
  • written consent is given

Exclusion Criteria:

  • relapse during the last 30 days befor randomization
  • steroids within 30 days before randomization
  • heart rhythm disturbance
  • new or currently changed dose (last 4 weeks) of bata-blockers, calcium antagonists, antidepressants or antiarrhythmics
  • diabetes mellitus
  • polyneuropathy
  • missing consent
  • pregnancy
  • lactation period

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gilenya
Autonomic testing during first dose adminstration of Gilenya.
Drug: Gilenya
Autonomic testing during first dose administration of Gilenya.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RMSSD Normal Breathing
Time Frame: t-4,5 hours

Root Mean Square of the Successive Differences (RMSSD) is one of a few time-domain tools used to assess heart rate variability, the successive differences being neighboring RR or pulse intervals.

It is calculated as the square root of the mean of the squares of the successive differences between adjacent RR intervals or pulse intervals.

In this study pulse intervals were measured non-invasively during five minutes, while subjects were supine, breathing regularly.

Measurements were done at two timepoints t=0 and t=4,5hours. RMSSD was compared between these two timepoints.
t-4,5 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jochen Vehoff

Investigators

  • Principal Investigator: Jochen Vehoff, MD, Cantonal Hospital of St. Gallen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

January 27, 2014

First Submitted That Met QC Criteria

January 27, 2014

First Posted (Estimate)

January 29, 2014

Study Record Updates

Last Update Posted (Estimate)

April 29, 2016

Last Update Submitted That Met QC Criteria

March 30, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANSG 1.8

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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