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

Multiple Sclerosis, Pharmacokinetics Clinical Trial

Official title:

Determination of Teriflunomide Concentration in Serum and Cerebrospinal Fluid From Patients With Multiple Sclerosis Treated With Teriflunomide 14 mg Daily.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04129736
• Other study ID #: TERIFL0519
• Secondary ID: 2016-004414-10
• Status: Completed
• Phase: Phase 4
• Start date: October 10, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: December 2022
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 30, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Pharmacokinetics
• Sclerosis

Intervention

Drug:
• Teriflunomide 14 MG
Blood and cerebrospinal fluid is obtained from teriflunomide treated patients with multiple sclerosis

Locations

Country	Name	City	State
Sweden	MS Centre	Gothenburg	Vastra Gotaland

Sponsors (1)

Lead Sponsor	Collaborator
Jan Lycke

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of teriflunomide in cerebrospinal fluid		one year