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 ↗ | 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. |
| 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 |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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