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Last Updated: September 23, 2021

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CLINICAL TRIALS PROFILE FOR AUBAGIO

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All Clinical Trials for Aubagio

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00622700 ↗ Phase III Study With Teriflunomide Versus Placebo in Patients With First Clinical Symptom of Multiple Sclerosis Completed Sanofi Phase 3 2008-02-01 The primary objective is to demonstrate the effect of teriflunomide (HMR1726) (14 milligram per day [mg/day] and 7 mg/day), in comparison to placebo, for reducing conversion of participants presenting with their first clinical episode consistent with multiple sclerosis (MS) to clinically definite multiple sclerosis (CDMS). The secondary objectives are: - To demonstrate the effect of teriflunomide, in comparison to placebo, on: - Reducing conversion to definite multiple sclerosis (DMS) - Reducing annualized relapse rate (ARR) - Reducing disease activity/progression as measured by Magnetic Resonance Imaging (MRI) - Reducing accumulation of disability for at least 12 weeks as measured by the Expanded Disability Status Scale (EDSS) - Proportion of disability-free participants as assessed by the EDSS - Reducing participant-reported fatigue - To evaluate the safety and tolerability of teriflunomide - To evaluate the pharmacokinetics (PK) of teriflunomide - Optional pharmacogenomic testing aimed at assessing the association between the main enzyme systems of teriflunomide metabolism and hepatic safety, and other potential associations between gene variations and clinical outcomes
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.
NCT01838174 ↗ A Phase IV Trial of Neuroprotection With ACTH in Acute Optic Neuritis Unknown status Mallinckrodt Phase 4 2013-05-01 We hypothesize that the novel melanocortin-mediated anti-inflammatory effects of Adrenocorticotropic hormone (ACTH) will reduce axonal loss following ON by limiting inflammatory optic nerve injury. We will compare the effect of ACTH and intravenous methylprednisolone therapy on axonal injury following ON using ocular coherence tomography (OCT), a sensitive, reproducible and noninvasive tool to measure retinal nerve fiber layer (RNFL) thickness. The primary outcome will be the average RNFL thickness at 6 months. Additional pre-specified statistical analyses will compare the difference in the mean RNFL thickness at 6 months in the affected eye between the IV methylprednisolone- and Acthar-treated groups, and the mean 6-month affected eye RNFL thicknesses adjusted for the baseline unaffected eye RNFL. The secondary outcome measure will examine the frequency of optic nerves with RNFL swelling between the IV methylprednisolone- and Acthar-treated groups at 1 and 3 months. The tertiary outcome will be changes in mfVEP amplitude and latency, ONHP detection, and pupillary diameter (UTSW only). A predefined exploratory outcome will compare the ganglion cell plus inner plexiform layer (GC+IPL) thickness at 6 months between treatment groups
NCT01838174 ↗ A Phase IV Trial of Neuroprotection With ACTH in Acute Optic Neuritis Unknown status University of Colorado, Denver Phase 4 2013-05-01 We hypothesize that the novel melanocortin-mediated anti-inflammatory effects of Adrenocorticotropic hormone (ACTH) will reduce axonal loss following ON by limiting inflammatory optic nerve injury. We will compare the effect of ACTH and intravenous methylprednisolone therapy on axonal injury following ON using ocular coherence tomography (OCT), a sensitive, reproducible and noninvasive tool to measure retinal nerve fiber layer (RNFL) thickness. The primary outcome will be the average RNFL thickness at 6 months. Additional pre-specified statistical analyses will compare the difference in the mean RNFL thickness at 6 months in the affected eye between the IV methylprednisolone- and Acthar-treated groups, and the mean 6-month affected eye RNFL thicknesses adjusted for the baseline unaffected eye RNFL. The secondary outcome measure will examine the frequency of optic nerves with RNFL swelling between the IV methylprednisolone- and Acthar-treated groups at 1 and 3 months. The tertiary outcome will be changes in mfVEP amplitude and latency, ONHP detection, and pupillary diameter (UTSW only). A predefined exploratory outcome will compare the ganglion cell plus inner plexiform layer (GC+IPL) thickness at 6 months between treatment groups
NCT01838174 ↗ A Phase IV Trial of Neuroprotection With ACTH in Acute Optic Neuritis Unknown status Elliot Frohman Phase 4 2013-05-01 We hypothesize that the novel melanocortin-mediated anti-inflammatory effects of Adrenocorticotropic hormone (ACTH) will reduce axonal loss following ON by limiting inflammatory optic nerve injury. We will compare the effect of ACTH and intravenous methylprednisolone therapy on axonal injury following ON using ocular coherence tomography (OCT), a sensitive, reproducible and noninvasive tool to measure retinal nerve fiber layer (RNFL) thickness. The primary outcome will be the average RNFL thickness at 6 months. Additional pre-specified statistical analyses will compare the difference in the mean RNFL thickness at 6 months in the affected eye between the IV methylprednisolone- and Acthar-treated groups, and the mean 6-month affected eye RNFL thicknesses adjusted for the baseline unaffected eye RNFL. The secondary outcome measure will examine the frequency of optic nerves with RNFL swelling between the IV methylprednisolone- and Acthar-treated groups at 1 and 3 months. The tertiary outcome will be changes in mfVEP amplitude and latency, ONHP detection, and pupillary diameter (UTSW only). A predefined exploratory outcome will compare the ganglion cell plus inner plexiform layer (GC+IPL) thickness at 6 months between treatment groups
NCT01970410 ↗ Safety and Effectiveness of Switching Relapsing MS Patients Treated With Natalizumab at Risk for PML to Teriflunomide Active, not recruiting Providence Multiple Sclerosis Center Phase 4 2013-10-01 The purpose of this study is to determine if teriflunomide will be safe and effective to prevent relapses in patients with relapsing types of MS when switching from natalizumab to teriflunomide in patients at risk for PML. This is a two center interventional study of patients who have had 12 or more continuous infusions of natalizumab , who are anti-JCV-ab positive, and who had been free of clinical relapses during prior 12 months of natalizumab therapy who will be switching to teriflunomide.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Aubagio

Condition Name

Condition Name for Aubagio
Intervention Trials
Relapsing Multiple Sclerosis 5
Multiple Sclerosis 4
Primary-progressive Multiple Sclerosis 1
Teriflunomide Elimination 1
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Condition MeSH

Condition MeSH for Aubagio
Intervention Trials
Multiple Sclerosis 12
Sclerosis 10
Multiple Sclerosis, Relapsing-Remitting 3
Optic Neuritis 1
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Clinical Trial Locations for Aubagio

Trials by Country

Trials by Country for Aubagio
Location Trials
United States 49
Germany 3
Canada 2
United Kingdom 2
Hungary 1
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Trials by US State

Trials by US State for Aubagio
Location Trials
Florida 4
Colorado 4
Massachusetts 3
Texas 3
Tennessee 3
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Clinical Trial Progress for Aubagio

Clinical Trial Phase

Clinical Trial Phase for Aubagio
Clinical Trial Phase Trials
Phase 4 3
Phase 3 7
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Aubagio
Clinical Trial Phase Trials
Recruiting 4
Not yet recruiting 4
Active, not recruiting 1
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Clinical Trial Sponsors for Aubagio

Sponsor Name

Sponsor Name for Aubagio
Sponsor Trials
Sanofi 3
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany 2
EMD Serono Research & Development Institute, Inc. 2
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Sponsor Type

Sponsor Type for Aubagio
Sponsor Trials
Industry 12
Other 11
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