CLINICAL TRIALS PROFILE FOR TERIFLUNOMIDE
✉ Email this page to a colleague
All Clinical Trials for TERIFLUNOMIDE
Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
---|---|---|---|---|---|---|
NCT00134563 ↗ | Study of Teriflunomide in Reducing the Frequency of Relapses and Accumulation of Disability in Patients With Multiple Sclerosis | Completed | Sanofi | Phase 3 | 2004-09-01 | The primary objective was to determine the effect of teriflunomide on the frequency of relapses in patients with relapsing multiple sclerosis (MS). Secondary objectives were: - to evaluate the effect of teriflunomide on the accumulation of disability as measured by Expanded Disability Status Scale [EDSS], the burden of disease as measured by Magnetic Resonance Imaging [MRI] and patient-reported fatigue; - to evaluate the safety and tolerability of teriflunomide. |
NCT00228163 ↗ | Long Term Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses | Completed | Sanofi | Phase 2 | 2002-01-01 | The primary objective is to assess the long-term safety of teriflunomide in multiple sclerosis subjects. The secondary objective is to assess the long-term efficacy. |
NCT00475865 ↗ | Phase II Study of Teriflunomide as Adjunctive Therapy to Glatiramer Acetate in Subjects With Multiple Sclerosis | Completed | Sanofi | Phase 2 | 2007-04-01 | The primary objective was to estimate the tolerability and safety of 2 doses of Teriflunomide administered once daily for 24 weeks, compared to placebo, in patients with multiple sclerosis [MS] with relapses who were on a stable dose of Glatiramer Acetate [GA]. The secondary objectives were: - to estimate the effect of the 2 doses of Teriflunomide, compared to placebo, in combination with a stable dose of GA on Magnetic Resonance Imaging [MRI] parameters, relapse rate and patient-reported fatigue; - to perform pharmacokinetic analyses of the 2 doses of teriflunomide in combination with a stable dose of GA. |
NCT00489489 ↗ | Phase II Study of Teriflunomide as Adjunctive Therapy to Interferon-beta in Subjects With Multiple Sclerosis | Completed | Sanofi | Phase 2 | 2007-05-01 | The primary objective was to estimate the tolerability and safety of 2 doses of teriflunomide administered once daily for 24 weeks, compared with placebo, in patients with multiple sclerosis [MS] with relapses who were on a stable dose of interferon-β [IFN-β]. Secondary objectives were: - to estimate the effects of the 2 doses of teriflunomide, compared to placebo, in combination with a stable dose of IFN-β on Magnetic Resonance Imaging [MRI] parameters, relapse rate and patient-reported fatigue; - to perform pharmacokinetic analyses of the 2 doses of teriflunomide in combination with a stable dose of IFN-β. |
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 was 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 were: - 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 |
>Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
Clinical Trial Conditions for TERIFLUNOMIDE
Condition Name
Clinical Trial Locations for TERIFLUNOMIDE
Trials by Country
Clinical Trial Progress for TERIFLUNOMIDE
Clinical Trial Phase
Clinical Trial Sponsors for TERIFLUNOMIDE
Sponsor Name