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Gilenya (Fingolimod Hydrochloride) - Summary

 
 



GILENYA SUMMARY

Fingolimod is a sphingosine 1-phosphate receptor modulator.

GILENYA is indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS) to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability.


See all Gilenya indications & dosage >>

NEWS HIGHLIGHTS

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

more studies >>

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).

more trials >>

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 >>


Page last updated: 2015-08-10

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