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

Jan Lycke

Status and phase: Completed; Phase 4

Conditions: Multiple Sclerosis, Pharmacokinetics

Treatments: Drug: Teriflunomide 14 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT04129736

2016-004414-10 (EudraCT Number)

TERIFL0519

Details and patient eligibility

About

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

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Teriflunomide 14 mg tablets

Other group

Description:

Single arm

Treatment:

Drug: Teriflunomide 14 MG