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

NCT02048072 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2016-04-29

Study results available
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Summary

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".

Conditions

Interventions

DRUG

Gilenya

Autonomic testing during first dose administration of Gilenya.

Sponsors & Collaborators

  • Jochen Vehoff

    lead OTHER

Principal Investigators

  • Jochen Vehoff, MD · Cantonal Hospital of St. Gallen

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • Switzerland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02048072 on ClinicalTrials.gov