Back to resultsTeriflunomide Concentration in Serum and Cerebrospinal Fluid From Patients With Multiple Sclerosis
Primary Purpose
Multiple Sclerosis, Pharmacokinetics
Status
Completed
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
Teriflunomide 14 MG
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis, Pharmacokinetics
Eligibility Criteria
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
Sites / Locations
- MS Centre
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Teriflunomide 14 mg tablets
Arm Description
Single arm
Outcomes
Primary Outcome Measures
Concentration of teriflunomide in cerebrospinal fluid
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04129736
Brief Title
Teriflunomide Concentration in Serum and Cerebrospinal Fluid From Patients With Multiple Sclerosis
Official Title
Determination of Teriflunomide Concentration in Serum and Cerebrospinal Fluid From Patients With Multiple Sclerosis Treated With Teriflunomide 14 mg Daily.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
October 10, 2019 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jan Lycke
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Pharmacokinetics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Pharmacokinetic
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Teriflunomide 14 mg tablets
Arm Type
Other
Arm Description
Single arm
Intervention Type
Drug
Intervention Name(s)
Teriflunomide 14 MG
Intervention Description
Blood and cerebrospinal fluid is obtained from teriflunomide treated patients with multiple sclerosis
Primary Outcome Measure Information:
Title
Concentration of teriflunomide in cerebrospinal fluid
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
MS Centre
City
Gothenburg
State/Province
Vastra Gotaland
ZIP/Postal Code
41345
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No additional plan will be added
Learn more about this trial
Teriflunomide Concentration in Serum and Cerebrospinal Fluid From Patients With Multiple Sclerosis
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