Teriflunomide Concentration in Serum and Cerebrospinal Fluid From Patients With Multiple Sclerosis

Phase 4

Completed

• Conditions: Multiple Sclerosis, Pharmacokinetics
• Interventions: Drug: Teriflunomide 14 MG

• Registration Number: NCT04129736
• Lead Sponsor: Jan Lycke

Brief Summary

Serum and cerebrospinal fluid will be obtained from 20 patients with relapsing-remitting multiple sclerosis treated with teriflunomide tablets 14 mg daily

Detailed Description

Teriflunomide concentration in cerebrospinal fluid and serum will be determined in 12 patients with multiple sclerosis. They have been treated for at least 6 months and the sampling from blood and by spinal tap is done before dose at 8 am in 10 patients and at 12 am in 10 patients. The dependence from age, sex, and blood-brain barrier (BBB) integrity will be evaluated.The ratio between serum and cerebrospinal fluid will determine the passage over the BBB.

Study Timeline

• Study Start: 2019-10-10
• Study First Submitted: 2019-10-15
• Study First Submitted QC: 2019-10-15
• Study First Posted: 2019-10-17
• Primary Completion: 2021-03-31
• Study Completion: 2021-06-30
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-09
• Last Update Posted: 2022-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• patients with multiple sclerosis treated with teriflunomide 14 mg for at least 6 months

Exclusion Criteria

• other immunosuppressive or immunomodulating drugs, other CNS diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Teriflunomide 14 mg tablets	Teriflunomide 14 MG	Single arm

Primary Outcome Measures

Name	Time	Method
Concentration of teriflunomide in cerebrospinal fluid	one year

Trial Locations

Locations (1)

MS Centre; 🇸🇪 Gothenburg, Vastra Gotaland, Sweden