The effect of teriflunomide on brain microglial cell activation in multiple sclerosis.

Phase 1

• Conditions: Multiple sclerosis; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2016-003622-16-FI
• Lead Sponsor: Turku University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-27
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-Signing the consent form
-Having used teriflunomide treatment for at least 6 months
-40-55 years of age at the time of signing the research consent form
-MS diagnosis in accordance with either the Poser or McDonald criteria
-EDSS 2-6.5
-Clear lesion load in brain MRI (>9 T2 lesions)
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 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Patients suffering from another brain disease in addition to MS
-Significant pathology in the MRI scan other than MS-related pathology
-Steroid treatment within 4 weeks prior to the scan
-Patients suffering from claustrophobia or panic disorder, or patients who have exhibited hypersensitivity of PET markers (practical obstacle to the scan)
-Exposure to experimental radioactivity in the last 12 months such that the dosimetry threshold would be exceeded due to participation in the study
-Severe hepatic impairment
-Pregnant women, or women of childbearing potential who are not using reliable contraception during treatment with teriflunomide and thereafter as long as its plasma levels are above 0.02 mg/l.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified