E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Determination of the concentration of Teriflunomide in serum and cerebrospinal fluid from patients with multiple sclerosis who are treated with teriflunomide 14 mg daily. |
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E.2.2 | Secondary objectives of the trial |
• To determine and quantify transportation of teriflunomide over the blood brain barrier • To determine the concentration of teriflunomide in CSF and fluctuations of the teriflunomide concentration during the course of the day • To determine if the teriflunomide concentration is affected by the function of the blood brain barrier • To investigate if there are other factors (for example age, disease duration, gender, clinical and radiological activity and severity) affecting the concentration of teriflunomide in CSF • To investigate if specified biomarkers for neurodegeneration and inflammatory activity (NFL, GFAP, CHI3L1, and CXCL13) is affected by the concentration of teriflunomide
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Patients with relapsing form of MS, treated with teriflunomide for a minimum of 6 months • Age 18-65 • Patients having signed written informed consent
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E.4 | Principal exclusion criteria |
• Patients treated with other enzyme inducing treatments • Patients with a disease with potential to affect the absorption, metabolization or elimination of teriflunomide • Patients with other CNS disease • Patients treated with other immunosuppressive or immune modulating treatments. If high dose steroids has been given, visit number 2 will be performed 30 days after the last dose of steroids. • Patients with increased risk of bleeding due to disturbances in coagulation or treatment with anticoagulant treatment. • Patient with an active relapse with a debut of less than 30 days from visit 2 • Women of child-bearing potential, not using reliable contraception • Pregnant or breast feeding women
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E.5 End points |
E.5.1 | Primary end point(s) |
Determination of the concentration of Teriflunomide in serum and cerebrospinal fluid from patients with multiple sclerosis who are treated with teriflunomide 14 mg daily. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At visit 2, four weeks from screening |
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E.5.2 | Secondary end point(s) |
• To determine and quantify transportation of teriflunomide over the blood brain barrier • To determine the concentration of teriflunomide in CSF and fluctuations of the teriflunomide concentration during the course of the day • To determine if the teriflunomide concentration is affected by the function of the blood brain barrier • To investigate if there are other factors (for example age, disease duration, gender, clinical and radiological activity and severity) affecting the concentration of teriflunomide in CSF • To investigate if specified biomarkers for neurodegeneration and inflammatory activity (NFL, GFAP, CHI3L1, and CXCL13) is affected by the concentration of teriflunomide
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At visit 2, four weeks from screening |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last Subject Last Visit (LSLV) |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |