Teriflunomide Concentration in Serum and Cerebrospinal Fl... | NCT04129736

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

NCT04129736

Sponsor

Jan Lycke

Status

Completed

Last Update Posted

Dec 12, 2022Actual

Enrollment

12Actual

Phase

Phase 4

Conditions

Multiple Sclerosis, Pharmacokinetics

Interventions

Teriflunomide 14 MG

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2016-004414-10	EudraCT Number

Status Module

Record Verification Date

Dec 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 10, 2019Actual

Primary Completion Date

Mar 31, 2021Actual

Completion Date

Jun 30, 2021Actual

First Submitted Date

Oct 15, 2019

First Submission Date that Met QC Criteria

Oct 15, 2019

First Posted Date

Oct 17, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 9, 2022

Last Update Posted Date

Dec 12, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Teriflunomide 14 mg tablets	Other	Single arm	Drug: Teriflunomide 14 MG

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Teriflunomide 14 MG	Drug	Blood and cerebrospinal fluid is obtained from teriflunomide treated patients with multiple sclerosis	Teriflunomide 14 mg tablets

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Concentration of teriflunomide in cerebrospinal fluid		one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
MS Centre		Gothenburg	Västra Götaland County	41345	Sweden

IPD Sharing Statement Module

Plan to Share IPD

Description

No additional plan will be added

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009103	Multiple Sclerosis

Ancestor Terms

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C527525	teriflunomide

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided