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

Jochen Vehoff

Status and phase: Completed; Phase 4

Conditions: Multiple Sclerosis; Autonomic Nervous System Dysfunction

Treatments: Drug: Gilenya

Study type: Interventional

Funder types: Other

Identifiers

NCT02048072

ANSG 1.8

Details and patient eligibility

About

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".

Enrollment: 33 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

Gilenya

Experimental group

Description:

Autonomic testing during first dose adminstration of Gilenya.

Treatment:

Drug: Gilenya