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CLINICAL TRIALS PROFILE FOR GILENYA

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All Clinical Trials for Gilenya

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.

Clinical Trial Conditions for Gilenya

Condition Name

Condition Name for Gilenya
Intervention	Trials
Multiple Sclerosis	9
Relapsing Remitting Multiple Sclerosis	5
Relapsing-remitting Multiple Sclerosis	2
Pain	1

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Condition MeSH

Condition MeSH for Gilenya
Intervention	Trials
Multiple Sclerosis	18
Sclerosis	16
Multiple Sclerosis, Relapsing-Remitting	10
Optic Neuritis	2

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Clinical Trial Locations for Gilenya

Trials by Country

Trials by Country for Gilenya
Location	Trials
United States	42
Germany	6
Canada	5
Spain	5
Australia	5

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Trials by US State

Trials by US State for Gilenya
Location	Trials
Texas	5
Colorado	5
California	4
New York	2
Pennsylvania	2

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Clinical Trial Progress for Gilenya

Clinical Trial Phase

Clinical Trial Phase for Gilenya
Clinical Trial Phase	Trials
Phase 4	11
Phase 2/Phase 3	2
Phase 2	5

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Clinical Trial Status

Clinical Trial Status for Gilenya
Clinical Trial Phase	Trials
Recruiting	7
Completed	6
Not yet recruiting	4

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Clinical Trial Sponsors for Gilenya

Sponsor Name

Sponsor Name for Gilenya
Sponsor	Trials
Novartis Pharmaceuticals	5
Novartis	5
Biogen	2

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Sponsor Type

Sponsor Type for Gilenya
Sponsor	Trials
Other	25
Industry	16
NIH	2

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