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CLINICAL TRIALS PROFILE FOR GILENYA

Clinical Trials for Gilenya

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Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00670449	An Extension Study of the Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing Multiple Sclerosis	Completed	Mitsubishi Tanabe Pharma Corporation	Phase 2	2008-04-01	This study was an extension study of NCT00537082. This study was designed to evaluate the efficacy and safety of long-term administration of 0.5 mg or 1.25 mg of fingolimod (FTY720) to relapsing multiple sclerosis.
NCT00670449	An Extension Study of the Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing Multiple Sclerosis	Completed	Novartis	Phase 2	2008-04-01	This study was an extension study of NCT00537082. This study was designed to evaluate the efficacy and safety of long-term administration of 0.5 mg or 1.25 mg of fingolimod (FTY720) to relapsing multiple sclerosis.
NCT01285479	Pregnancy Registry Trial	Recruiting	Novartis Pharmaceuticals	N/A	2011-10-01	The purpose of the Multi-National Gilenya Pregnancy Exposure Registry in Multiple Sclerosis (MS) is to continuously monitor, evaluate, and assess for major and minor teratogenic effects in the offspring of women exposed to Gilenya before (up to 8 weeks before last menstrual period) and during pregnancy in routine clinical practice. The overall aim is to collect and evaluate data on maternal, fetal, and infant outcomes and compare it with reference populations.
NCT01466114	Estriol Treatment in Multiple Sclerosis (MS): Effect on Cognition	Recruiting	Synthetic Biologics (formerly Adeona Pharmaceuticals)	Phase 2	2011-10-01	Approximately 50% of people diagnosed with Multiple Sclerosis (MS) will develop problems with cognition. Currently, there are no FDA-approved treatments targeting cognitive function in Multiple Sclerosis. This trial will ascertain whether treatment with an estrogen pill, used in combination with standard MS anti-inflammatory drugs, can improve cognitive testing as compared to treatment with a placebo pill in combination with standard anti-inflammatory drugs in women with MS.
NCT01466114	Estriol Treatment in Multiple Sclerosis (MS): Effect on Cognition	Recruiting	University of California, Los Angeles	Phase 2	2011-10-01	Approximately 50% of people diagnosed with Multiple Sclerosis (MS) will develop problems with cognition. Currently, there are no FDA-approved treatments targeting cognitive function in Multiple Sclerosis. This trial will ascertain whether treatment with an estrogen pill, used in combination with standard MS anti-inflammatory drugs, can improve cognitive testing as compared to treatment with a placebo pill in combination with standard anti-inflammatory drugs in women with MS.
NCT01534182	Evaluation of Patient Reported Outcomes in RRMS Patients Candidates for MS Therapy Change and Transitioned to Fingolimod 0.5 mg (EPOC)	Completed	Novartis Pharmaceuticals	Phase 4	2012-01-01	A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient Outcomes, Safety and Tolerability of (fingolimod) 0.5 mg/day in Patients with Relapsing Remitting Multiple Sclerosis who are candidates for MS therapy change from Previous Disease Modifying Therapy.
NCT01621269	ENGYNE Exploring Gilenya in Patients With Neutralizing Antibodies Against Interferon	Withdrawn	Novartis Pharmaceuticals	Phase 4	2013-06-01	Study to evaluate efficacy of fingolimod in patients with neutralizing antibodies over 12 months
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