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Generated: December 11, 2018

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CLINICAL TRIALS PROFILE FOR FINGOLIMOD HYDROCHLORIDE

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Clinical Trials for Fingolimod Hydrochloride

Trial ID Title Status Sponsor Phase Summary
NCT00273364 Stem Cell Therapy for Patients With Multiple Sclerosis Failing Alternate Approved Therapy- A Randomized Study Recruiting Sheffield Teaching Hospitals NHS Foundation Trust Phase 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 Study Recruiting University of Sao Paulo Phase 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 Study Recruiting Uppsala University Phase 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 Study Recruiting Northwestern University Phase 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 Sclerosis Completed Novartis Phase 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)
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Fingolimod Hydrochloride

Condition Name

Condition Name for Fingolimod Hydrochloride
Intervention Trials
Multiple Sclerosis 20
Relapsing Remitting Multiple Sclerosis 9
Relapsing-remitting Multiple Sclerosis 5
Multiple Sclerosis, Relapsing-Remitting 3
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Condition MeSH

Condition MeSH for Fingolimod Hydrochloride
Intervention Trials
Multiple Sclerosis 45
Sclerosis 43
Multiple Sclerosis, Relapsing-Remitting 29
Optic Neuritis 2
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Clinical Trial Locations for Fingolimod Hydrochloride

Trials by Country

Trials by Country for Fingolimod Hydrochloride
Location Trials
United States 276
Italy 77
Canada 43
Spain 40
Australia 26
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Trials by US State

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

Clinical Trial Phase

Clinical Trial Phase for Fingolimod Hydrochloride
Clinical Trial Phase Trials
Phase 4 23
Phase 3 12
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Fingolimod Hydrochloride
Clinical Trial Phase Trials
Completed 22
Recruiting 15
Terminated 6
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Clinical Trial Sponsors for Fingolimod Hydrochloride

Sponsor Name

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

Sponsor Type for Fingolimod Hydrochloride
Sponsor Trials
Industry 41
Other 25
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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Johnson and Johnson
Federal Trade Commission
Express Scripts
Fish and Richardson
Dow
US Army
Deloitte
Daiichi Sankyo

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