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Gilenya Medical Research Studies

Up-to-date List of Gilenya Medical Research Studies

What Research is Being Done?

A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. Following list includes both interventional and observational studies.

Latest Gilenya Medical Research Studies

Rank Status Study
1 Recruiting Biologic Basis for Multiple Sclerosis Disease Progression in RRMS Patients Treated With Gilenya
Condition: Multiple Sclerosis-Relapsing-Remitting
Intervention: Drug: Gilenya
Outcome Measures: Determination of disease progression of subjects treated with Gilenya over 5 years;   Change in cognitive function in patients treated with Gilenya;   Changes in biologic measures in patients treated with Gilenya;   Safety and tolerability of Gilenya therapy will be assessed
2 Recruiting Study to Assess Safety and Efficacy of Fingolimod in Children With Rett Syndrome
Condition: Rett's Syndrome
Intervention: Drug: fingolimod (FTY720)
Outcome Measure: Levels of Brain derived neurotrophic factor (BDNF) in blood and cerebrospinal fluid before and under treatment
3 Recruiting Gilenya in Amyotrophic Lateral Sclerosis (ALS)
Condition: Amyotrophic Lateral Sclerosis
Intervention: Drug: Gilenya
Outcome Measures: Safety;   Tolerability;   Measured effect of the treatment on circulating lymphocyte populations
4 Recruiting Evaluation of the Autonomic Nervous System During First-dosing With 0.5mg of Fingolimod (Gilenya) in Patients With Relapsing-remitting MS
Conditions: Multiple Sclerosis;   Autonomic Nervous System
Intervention: Drug: Gilenya
Outcome Measures: RMSSD;   HRV
5 Recruiting Efficacy of Fingolimod in de Novo Patients Versus Fingolimod in Patients Previously Treated With a First Line Disease Modifying Therapy
Condition: Relapsing Remitting Multiple Sclerosis
Intervention: Drug: Fingolimod (FTY720)
Outcome Measures: Difference on Annual Relapse Rate for both groups;   Time to first relapse;   Disability progression
6 Recruiting Long-term Safety and Tolerability of 0.5 mg Fingolimod in Patients With Relapsing Forms of Multiple Sclerosis
Condition: Relapsing Forms of Multiple Sclerosis
Intervention: Drug: FTY720
Outcome Measures: Long-term safety & tolerability of fingolimod 0.5 mg/day in patients with relapsing forms of MS;   Long-term efficacy of fingolimod 0.5 mg/day in patients with relapsing forms of MS
7 Recruiting Effects of Gilenya (Fingolimod) on Thalamus Pathology and Cognitive Impairment in Patients With Relapsing Forms of Multiple Sclerosis
Conditions: Multiple Sclerosis;   Healthy
Intervention:
Outcome Measures: Thalamic atrophy;   Thalamic pathology;   Cognitive impairment;   Thalamic volume and accumulation of iron in response to herpes viruses
8 Recruiting Efficacy and Safety of FTY720 for Acute Stroke
Conditions: Stroke;   Vascular Accident;   Cerebral Stroke;   Ischemic Cerebrovascular Accident;   Stroke, Acute
Intervention: Drug: Fingolimod
Outcome Measures: Clinical improvement;   Change in image;   Change in immunology function
9 Recruiting OL, Single-arm Extension Study to the Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5 mg FTY720 Administered Orally Once Daily Versus Placebo in Patients With Primary Progressive Multiple Sclerosis
Condition: Primary Progressive Multiple Sclerosis
Intervention: Drug: FTY720
Outcome Measures: Change from baseline in Disease activity measured by Kurtzke's Expanded Disability Status Scale (EDSS);   Change from baseline inDisease activity measured by 9-Hole Peg Test (9HPT);   Change in Disease activity measured by 25 ft Timed Walk Test (25'TWT);   Change in Disease Activity measured by Magnetic Resonance Imaging (MRI) parameters;   Number of patients with AE/SAE as assessment of safety and tolerability
10 Recruiting A 12 -Month, Open-label, Multi-center Study to Explore the Health Outcomes of FTY720
Conditions: Multiple Sclerosis;   Relapsing-Remitting
Intervention: Drug: Fingolimod
Outcome Measures: Change in patient-reported treatment satisfaction using the global satisfaction subscale of the Treatment Satisfaction Questionnaire for Medication;   Change in patient-reported health-related quality-of-life with Fingolimod (;   Tolerability evaluations will be via ophthalmologic examination, first Dose Monitoring, ECG, Hematology, Serology and Blood chemistry
11 Recruiting Fingolimod in Schizophrenia Patients
Condition: Schizophrenia
Interventions: Drug: Fingolimod;   Drug: placebo
Outcome Measures: Dosing Safety;   Cognition, including executive functioning, verbal fluency, attention, task switching, and motor speed;   verbal memory;   Positive and Negative Symptoms of Schizophrenia;   plasma cytokines;   working memory;   DTI-derived FA
12 Recruiting Long-term Effect of Fingolimod on Circulating Immunocompetent Mononuclear Cells in Patients With Multiple Sclerosis
Condition: Relapsing Remitting Multiple Sclerosis
Intervention: Drug: Fingolimod
Outcome Measures: Reduction of CD4+ and CD8+ naïve T cells (CCR7+ CD45RA+) and central memory T cells (CCR7+CD45RA-), and an elevation of effector memory T cells (CCR7- CD45RA-) by examining the blood;   To investigate changes from baseline in B Lymphocytes, monocytes and NK cells in the blood after treatment with fingolimod
13 Recruiting MS Study Evaluating Safety and Efficacy of Two Doses of Fingolimod Versus Copaxone
Condition: Relapsing-remitting Multiple Sclerosis (RRMS)
Interventions: Drug: fingolimod;   Drug: copaxone
Outcome Measures: Comparison of 2 doses (0.25 mg and .5 mg) of fingolimod to glatiramer acetate (20 mg) in reducing the annualized relapse rate up to 12 months;   change from Baseline in brain volume;   number of active T2 lesions (new or newly enlarging lesions compared with Baseline);   proportion of patients free of new or newly enlarging T2 lesions compared to Baseline;   change from Baseline in T2 lesion volume;   change from Baseline in the number and volume of T1 hypointense lesions;   number and volume of gadolinium (Gd)-enhancing T1 lesions;   safety and tolerability;   change from baseline in treatment satisfaction as measured by the Treatment Satisfaction Questionnaire for Medication (TSQM)
14 Recruiting Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis
Condition: Multiple Sclerosis
Interventions: Drug: Interferon beta-1a i.m. injections;   Drug: Fingolimod oral capsules;   Drug: Placebo oral capsule;   Drug: Placebo i.m. injection
Outcome Measures: Frequency of relapses" in patients treated for up to 24 months;   Number of new/newly enlarged T2 (n/neT2) lesions;   Frequency and nature of adverse events as a measure of Safety and Tolerability;   Pharmacokinetics (Cavg)of fingolimod and fingolimod-P
15 Recruiting Computerized Exercise Training for Cognitive Remediation in Adults With Multiple Sclerosis Treated With Gilenya
Conditions: Multiple Sclerosis;   Cognitive Deficits;   Gilenya Modifying Therapy for MS
Interventions: Other: plasticity-based computerized cognitive remediation program;   Drug: Gileyna
Outcome Measures: Change from Baseline in Neuropsychological Test Results at 12weeks;   Evaluate the feasibility of PACR for adults with MS on Gilenya therapy who have cognitive impairment based on Participant Adherence to Study Protocol
16 Recruiting A Pilot Study Assessing the Impact of Gilenya Therapy on Bone Density Change in Relapsing Forms of Multiple Sclerosis
Condition: Multiple Sclerosis
Intervention:
Outcome Measure: Assess change in bone mass density in subjects taking Gilenya versus subjects taking alternative disease modifying therapy or no therapy.
17 Recruiting Monitoring Natural Killer Cells in Multiple Sclerosis Patients Treated With Fingolimod
Condition: Relapsing-Remitting Multiple Sclerosis
Intervention:
Outcome Measures: Status of NK cell maturation;   NK cell frequency;   Percentage immature NK cells/total NK cells;   NK cell activation;   NK cell maturation and activation;   NK cell cytotoxicity and the cytokine production
18 Recruiting Pregnancy Registry Trial
Condition: Multiple Sclerosis
Intervention: Drug: Fingolimod
Outcome Measure: Major malformations, minor congenital anomalies & overall pregnancy outcomes will be collected; Complications during pregnancy, potential AEs on the physical & immune system development of the offspring, & any other adverse pregnancy/maternal outcomes.
19 Recruiting MOdification of VIsual Outcomes After Optic Neuritis in CIS or MS by Gilenya (MOVING Study)
Condition: Multiple Sclerosis
Interventions: Drug: Verum arm receiving Gilenya®;   Drug: Active Comparator receiving Extavia®
Outcome Measure: Efficacy parameters
20 Recruiting Evaluate Efficacy and Safety of Fingolimod 0.5 mg Orally Once Daily Versus Placebo in Chronic Inflammatory Demyelinating Polyradiculoneuropathy Patients.
Condition: Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Interventions: Drug: Fingolimod;   Drug: Placebo Comparator
Outcome Measures: time to first confirmed worsening on the adjusted INCAT Disability Scale by 1 point or more from the value at Baseline, in patients who being treated with IVIg and/or corticosteroids prior to the study start.;   The change from Baseline for grip strength;   The change from Baseline for Rasch-Built Linearly Weighted Overall Disability Scale (R-ODS);   safety and tolerability of fingolimod compared with placebo in patients with CIDP

These studies may lead to new treatments and are adding insight into Gilenya etiology and treatment.

A major focus of Gilenya research is the development of new drugs and other treatment options. Studies seek to identify new drugs to treat various related disorders and to find safer, more effective doses for medications already being used. Other research is aimed at identifying receptors or drug targets.


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