NEWS HIGHLIGHTSMedia Articles Related to Gilenya (Fingolimod)
Cardiac Effects of Fingolimod in MS Reversible Source: Medscape NeurologyHeadlines [2017.09.25] Fingolimod, used to treat multiple sclerosis, dampens cardiac autonomic modulation at rest and during challenges, but this effect appears to be reversible after discontinuation of the drug, a study shows. Medscape Medical News
Published Studies Related to Gilenya (Fingolimod)
Fingolimod (FTY720) therapy in Japanese patients with relapsing multiple
sclerosis over 12 months: results of a phase 2 observational extension. [2014] switched from placebo to fingolimod... CONCLUSION: Continuous fingolimod treatment for up to 12 months was associated
Translational pharmacokinetic modeling of fingolimod (FTY720) as a paradigm
compound subject to sphingosine kinase-mediated phosphorylation. [2014] A complicating factor in the translational pharmacology of sphingosine
1-phosphate agonists is that they exert their pharmacological effect through
their respective phosphate metabolites, which are formed by the enzyme
sphingosine kinase (S1PHK). In this investigation, we present a semimechanistic
pharmacokinetic model for the interconversion of S1PHK substrates and their
respective phosphates in rats and humans with the aim of investigating whether
characterization of the rate of phosphorylation in blood platelets constitutes a
basis for interspecies scaling using fingolimod as a model compound...
Ophthalmic evaluations in clinical studies of fingolimod (FTY720) in multiple
sclerosis. [2013] for multiple sclerosis (MS)... CONCLUSIONS: Fingolimod 0.5 mg is associated with a low incidence of ME in MS
A randomized, controlled trial of fingolimod (FTY720) in Japanese patients with
multiple sclerosis. [2012] with relapsing MS treated with fingolimod... CONCLUSIONS: This study demonstrated the clinical efficacy of fingolimod for the
Ethnic sensitivity study of fingolimod in white and Asian subjects. [2007] potential ethnic differences... CONCLUSION: There were no marked differences between healthy white and Asian
Clinical Trials Related to Gilenya (Fingolimod)
Biologic Basis for Multiple Sclerosis Disease Progression in RRMS Patients Treated With Gilenya [Recruiting]
This study will determine whether in RRMS patients receiving Gilenya there is a link between
disease progression and biologic markers.
Gilenya in Amyotrophic Lateral Sclerosis (ALS) [Active, not recruiting]
The purpose of this study is to determine whether Gilenya, also known as fingolimod, is safe
and tolerable in patients with Amyotrophic Lateral Sclerosis (ALS).
Evaluation of the Autonomic Nervous System During First-dosing With 0.5mg of Fingolimod (Gilenya) in Patients With Relapsing-remitting MS [Completed]
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".
Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis [Completed]
This study assessed the safety, tolerability and efficacy of two doses of oral fingolimod
compared to placebo on efficacy parameters in patients with relapsing-remitting multiple
sclerosis (RRMS).
Long-term Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis [Completed]
This extension study of was designed to evaluate the long-term safety, tolerability, and
efficacy of fingolimod (FTY720) in patients with multiple sclerosis. The Extension study was
an extension to the 24-month Core study (CFTY720D2301/NCT00289978).
Reports of Suspected Gilenya (Fingolimod) Side Effects
Fatigue (1333),
Headache (882),
Dizziness (763),
Nausea (745),
Dyspnoea (539),
Multiple Sclerosis Relapse (495),
Asthenia (474),
Vision Blurred (442),
Heart Rate Decreased (410),
Back Pain (389), more >>
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