Determination of the concentration of Teriflunomide in serum and cerebrospinal fluid from patients with multiple sclerosis who are treated with Teriflunomide 14 mg daily.
- Conditions
- Multiple SclerosisTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2016-004414-10-SE
- Lead Sponsor
- MS Centrum, Department of Neurology, Sshlgrenska University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 20
•Patients with relapsing form of MS, treated with teriflunomide for a minimum of 6 months
•Age 18-65
•Patients having signed written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
•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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method