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

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

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Key information

Conditions

Multiple Sclerosis, Pharmacokinetics Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

MS Centre

Gothenburg, Västra Götaland County, 41345, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Teriflunomide 14 MG

Drug

Blood and cerebrospinal fluid is obtained from teriflunomide treated patients with multiple sclerosis

Primary outcomes

Concentration of teriflunomide in cerebrospinal fluid

Time frame: one year

Sponsors and collaborators

Lead sponsor

Jan Lycke

Other

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2021
Study completion: 2021
First posted: Oct 17, 2019
Registry last updated: Dec 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed