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Generated: November 20, 2017

DrugPatentWatch Database Preview

CLINICAL TRIALS PROFILE FOR
FINGOLIMOD

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Clinical Trial Listing

Trial ID Title Status Sponsor Phase Summary
NCT00273364 Stem Cell Therapy for Patients With Multiple Sclerosis Failing Alternate Approved Therapy- A Randomized StudyRecruitingSheffield Teaching Hospitals NHS Foundation TrustPhase 3 Multiple sclerosis (MS) is at onset an immune-mediated demyelinating disease. In most cases, it starts as a relapsing-remitting disease with distinct attacks and no symptoms between flares. Over years or decades, virtually all cases transition into a progressive disease in which insidious and slow neurologic deterioration occurs with or without acute flares. Relapsing-remitting disease is often responsive to immune suppressive or modulating therapies, while immune based therapies are generally ineffective in patients with a progressive clinical course. This clinical course and response to immune suppression, as well as neuropathology and neuroimaging studies, suggest that disease progression is associated with axonal atrophy. Disability correlates better with measures of axonal atrophy than immune mediated demyelination. Therefore, immune based therapies, in order to be effective, need to be started early in the disease course while MS is predominately an immune-mediated and inflammatory disease. While current immune based therapies delay disability, no intervention has been proven to prevent progressive disability. We propose, as a randomized study, autologous unmanipulated PBSCT using a conditioning regimen of cyclophosphamide and rATG versus FDA approved standard of care (i.e. interferon, glatiramer acetate, mitoxantrone, natalizumab, fingolimod, or tecfidera) in patients with inflammatory (relapsing) MS despite treatment with alternate approved therapy.
NCT00273364 Stem Cell Therapy for Patients With Multiple Sclerosis Failing Alternate Approved Therapy- A Randomized StudyRecruitingUniversity of Sao PauloPhase 3 Multiple sclerosis (MS) is at onset an immune-mediated demyelinating disease. In most cases, it starts as a relapsing-remitting disease with distinct attacks and no symptoms between flares. Over years or decades, virtually all cases transition into a progressive disease in which insidious and slow neurologic deterioration occurs with or without acute flares. Relapsing-remitting disease is often responsive to immune suppressive or modulating therapies, while immune based therapies are generally ineffective in patients with a progressive clinical course. This clinical course and response to immune suppression, as well as neuropathology and neuroimaging studies, suggest that disease progression is associated with axonal atrophy. Disability correlates better with measures of axonal atrophy than immune mediated demyelination. Therefore, immune based therapies, in order to be effective, need to be started early in the disease course while MS is predominately an immune-mediated and inflammatory disease. While current immune based therapies delay disability, no intervention has been proven to prevent progressive disability. We propose, as a randomized study, autologous unmanipulated PBSCT using a conditioning regimen of cyclophosphamide and rATG versus FDA approved standard of care (i.e. interferon, glatiramer acetate, mitoxantrone, natalizumab, fingolimod, or tecfidera) in patients with inflammatory (relapsing) MS despite treatment with alternate approved therapy.
NCT00273364 Stem Cell Therapy for Patients With Multiple Sclerosis Failing Alternate Approved Therapy- A Randomized StudyRecruitingUppsala UniversityPhase 3 Multiple sclerosis (MS) is at onset an immune-mediated demyelinating disease. In most cases, it starts as a relapsing-remitting disease with distinct attacks and no symptoms between flares. Over years or decades, virtually all cases transition into a progressive disease in which insidious and slow neurologic deterioration occurs with or without acute flares. Relapsing-remitting disease is often responsive to immune suppressive or modulating therapies, while immune based therapies are generally ineffective in patients with a progressive clinical course. This clinical course and response to immune suppression, as well as neuropathology and neuroimaging studies, suggest that disease progression is associated with axonal atrophy. Disability correlates better with measures of axonal atrophy than immune mediated demyelination. Therefore, immune based therapies, in order to be effective, need to be started early in the disease course while MS is predominately an immune-mediated and inflammatory disease. While current immune based therapies delay disability, no intervention has been proven to prevent progressive disability. We propose, as a randomized study, autologous unmanipulated PBSCT using a conditioning regimen of cyclophosphamide and rATG versus FDA approved standard of care (i.e. interferon, glatiramer acetate, mitoxantrone, natalizumab, fingolimod, or tecfidera) in patients with inflammatory (relapsing) MS despite treatment with alternate approved therapy.
NCT00273364 Stem Cell Therapy for Patients With Multiple Sclerosis Failing Alternate Approved Therapy- A Randomized StudyRecruitingNorthwestern UniversityPhase 3 Multiple sclerosis (MS) is at onset an immune-mediated demyelinating disease. In most cases, it starts as a relapsing-remitting disease with distinct attacks and no symptoms between flares. Over years or decades, virtually all cases transition into a progressive disease in which insidious and slow neurologic deterioration occurs with or without acute flares. Relapsing-remitting disease is often responsive to immune suppressive or modulating therapies, while immune based therapies are generally ineffective in patients with a progressive clinical course. This clinical course and response to immune suppression, as well as neuropathology and neuroimaging studies, suggest that disease progression is associated with axonal atrophy. Disability correlates better with measures of axonal atrophy than immune mediated demyelination. Therefore, immune based therapies, in order to be effective, need to be started early in the disease course while MS is predominately an immune-mediated and inflammatory disease. While current immune based therapies delay disability, no intervention has been proven to prevent progressive disability. We propose, as a randomized study, autologous unmanipulated PBSCT using a conditioning regimen of cyclophosphamide and rATG versus FDA approved standard of care (i.e. interferon, glatiramer acetate, mitoxantrone, natalizumab, fingolimod, or tecfidera) in patients with inflammatory (relapsing) MS despite treatment with alternate approved therapy.
NCT00289978 Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple SclerosisCompletedNovartisPhase 3 This study assessed the efficacy, safety, and tolerability of 2 doses of oral fingolimod (1.25 mg/day and 0.5 mg/day) compared to placebo in patients with relapsing-remitting multiple sclerosis (RRMS)
NCT00340834 Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension PhaseCompletedNovartisPhase 3 This study assessed the safety, tolerability, and efficacy of 2 doses of oral fingolimod versus interferon β-1a to reduce the frequency of relapses in patients with relapsing-remitting multiple sclerosis.
NCT00355134 Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple SclerosisCompletedNovartisPhase 3 This study assessed the safety, tolerability and efficacy of two doses of oral fingolimod compared to placebo on efficacy parameters in patients with relapsing-remitting multiple sclerosis (RRMS).
NCT00662649 Long-term Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple SclerosisCompletedNovartisPhase 3 This extension study of was designed to evaluate the long-term safety, tolerability, and efficacy of fingolimod (FTY720) in patients with multiple sclerosis. The Extension study was an extension to the 24-month Core study (CFTY720D2301/NCT00289978).
NCT00670449 An Extension Study of the Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing Multiple SclerosisCompletedMitsubishi Tanabe Pharma CorporationPhase 2 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 SclerosisCompletedNovartisPhase 2 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.
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Conditions

Condition Name

Condition Name for fingolimod
Intervention Trials
Multiple Sclerosis 20
Relapsing Remitting Multiple Sclerosis 7
Relapsing-remitting Multiple Sclerosis 5
Multiple Sclerosis, Relapsing-Remitting 3
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Condition MeSH

Condition MeSH for fingolimod
Intervention Trials
Multiple Sclerosis 43
Sclerosis 41
Multiple Sclerosis, Relapsing-Remitting 27
Stroke 2
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Trial Locations

Trials by Country

Trials by Country for fingolimod
Location Trials
United States 275
Italy 76
Canada 43
Spain 40
Australia 26
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Trials by US State

Trials by US State for fingolimod
Location Trials
Texas 13
Florida 12
California 11
Massachusetts 10
Pennsylvania 10
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Clinical Trial Progress

Clinical Trial Phase

Clinical Trial Phase for fingolimod
Clinical Trial Phase Trials
Phase 4 22
Phase 3 12
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for fingolimod
Clinical Trial Phase Trials
Completed 22
Recruiting 13
Terminated 6
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Clinical Trial Sponsors

Sponsor Name

Sponsor Name for fingolimod
Sponsor Trials
Novartis Pharmaceuticals 26
Novartis 10
Mitsubishi Tanabe Pharma Corporation 3
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Sponsor Type

Sponsor Type for fingolimod
Sponsor Trials
Industry 41
Other 21
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Serving leading biopharmaceutical companies globally:

AstraZeneca
Queensland Health
QuintilesIMS
Medtronic
Chinese Patent Office
Dow
Healthtrust
Cerilliant
Accenture
Mallinckrodt

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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