Evaluation of the Autonomic Nervous System During First-dosing With 0.5mg of Fingolimod (Gilenya) in Patients With Relapsing-remitting MS
Condition: Multiple Sclerosis; Autonomic Nervous System Dysfunction
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Gilenya
Intervention description: Autonomic testing during first dose administration of Gilenya.
Intervention MeSH terms: Fingolimod Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: relapsing remitting; multiple sclerosis; fingolimod; Gilenya; autonomic nervous system

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".
    

Eligibility criteria:

        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