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

Multiple Sclerosis Clinical Trial

— ANSG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02048072
• Other study ID #: ANSG 1.8
• Status: Completed
• Phase: Phase 4
• First received: January 27, 2014
• Last updated: July 28, 2015
• Start date: July 2013
• Est. completion date: June 2015

Study information

• Verified date: July 2015
• Source: Cantonal Hospital of St. Gallen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Autonomic Nervous System Dysfunction
• Multiple Sclerosis

Intervention

Drug:
• Gilenya
Autonomic testing during first dose administration of Gilenya.

Locations

Country	Name	City	State
Switzerland	Cantonal Hospital St. Gallen	St. Gallen	SG

Sponsors (1)

Lead Sponsor	Collaborator
Jochen Vehoff

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	result of autonomic testing	result of the autonomic testing at the three evaluation timepoints (pathologic vs. normal)	t=0, t=4,5h, t=3mo	No
Other	HR	heart rate at the three different evaluation time-points	t=0, t=4,5h, t=3mo	No
Other	RR	arterial blood-pressure at the three different evaluation time-points	t=0, t=4,5h, t=3mo	No
Other	EDSS	expanded disability status scale at the three different evaluation time-points	t=0, t=4,5h, t=3mo	No
Other	FSS	fatigue severity score at the three different evaluation time-points	t=0, t=4,5h, t=3mo	No
Other	COMPASS 31	refinded and abbreviated composite autonomic symptom score at the three different evaluation time-points	t=0, t=4,5h, t=3mo	No
Primary	RMSSD	change of heart rate variability at t4,5h compared to baseline (t0) for the parameter "RMSSD" under normal breathing	t-4,5 hours	No
Secondary	HRV	change of heart rate variability at t3mo compared to baseline (t0) and t4,5h for the parameter "RMSSD" under normal breathing, deep breathing and valsalva manouvre	t=3 months	No