CLINICAL TRIALS PROFILE FOR GILENYA

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 ↗	The Gilenya Pregnancy Registry	Recruiting	Novartis Pharmaceuticals		2011-10-15	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.

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
Inflammation	2

Condition MeSH

Condition MeSH for GILENYA
Intervention	Trials
Multiple Sclerosis	20
Sclerosis	19
Multiple Sclerosis, Relapsing-Remitting	12
Stroke	2

Clinical Trial Locations for GILENYA

Trials by Country

Trials by Country for GILENYA
Location	Trials
United States	83
Canada	12
China	10
Brazil	8
Italy	8

Trials by US State

Trials by US State for GILENYA
Location	Trials
Texas	6
California	5
Colorado	5
Ohio	4
Iowa	3

Clinical Trial Progress for GILENYA

Clinical Trial Phase

Clinical Trial Phase for GILENYA
Clinical Trial Phase	Trials
Phase 4	11
Phase 3	1
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for GILENYA
Clinical Trial Phase	Trials
Completed	14
Terminated	6
Recruiting	6

Clinical Trial Sponsors for GILENYA

Sponsor Name

Sponsor Name for GILENYA
Sponsor	Trials
Novartis Pharmaceuticals	8
Novartis	5
Huzhou Center Hospital	2

Sponsor Type

Sponsor Type for GILENYA
Sponsor	Trials
Other	43
Industry	20
NIH	2