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

NCT ID: NCT04129736

Last Updated: 2022-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-10

Study Completion Date

2021-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Multiple Sclerosis, Pharmacokinetics

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Pharmacokinetic
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Teriflunomide 14 mg tablets

Single arm

Group Type OTHER

Teriflunomide 14 MG

Intervention Type DRUG

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

Interventions

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Teriflunomide 14 MG

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jan Lycke

OTHER

Sponsor Role lead

Responsible Party

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Jan Lycke

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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MS Centre

Gothenburg, Västra Götaland County, Sweden

Site Status

Countries

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Sweden

Other Identifiers

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2016-004414-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

TERIFL0519

Identifier Type: -

Identifier Source: org_study_id