Multiple Sclerosis, PharmacokineticsPhase 4NCT04129736
Teriflunomide Concentration in Serum and Cerebrospinal Fluid From Patients With Multiple Sclerosis
A Phase 4 study testing Teriflunomide 14 MG in people with Multiple Sclerosis, Pharmacokinetics, run by Jan Lycke at 1 site in Sweden.
Trial summary
Serum and cerebrospinal fluid will be obtained from 20 patients with relapsing-remitting multiple sclerosis treated with teriflunomide tablets 14 mg daily Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Pharmacokinetics
- What is being tested?
- Teriflunomide 14 MG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSweden
- Study dates
- 10 Oct 2019to 30 Jun 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with multiple sclerosis treated with teriflunomide 14 mg for at least 6 months
Who cannot join
- other immunosuppressive or immunomodulating drugs, other CNS diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of Teriflunomide Concentration in Serum and Cerebrospinal Fluid From Patients With Multiple Sclerosis Treated With Teriflunomide 14 mg Daily.
Serum and cerebrospinal fluid will be obtained from 20 patients with relapsing-remitting multiple sclerosis treated with teriflunomide tablets 14 mg daily
Read the 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.
- Conditions
- Multiple Sclerosis, Pharmacokinetics
- Being tested
- Teriflunomide 14 MG
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teriflunomide 14 MGDrug
Blood and cerebrospinal fluid is obtained from teriflunomide treated patients with multiple sclerosis
| Study group | Role | What they receive |
|---|---|---|
| Teriflunomide 14 mg tablets | Other | Single arm Receives: Drug: Teriflunomide 14 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of teriflunomide in cerebrospinal fluid
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2019
- Study start10 Oct 2019
- Primary completion31 Mar 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis, PharmacokineticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pharmacokinetic
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jan Lycke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jan Lycke, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04129736
- Sponsor's protocol ID
- TERIFL0519
- Other IDs
- 2016-004414-10, 2016
- Status last verified
- Dec 2022
- First submitted
- 15 Oct 2019
- Last updated
- 12 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No additional plan will be added
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Teriflunomide Concentration in Serum and Cerebrospinal Fluid From Patients With Multiple Sclerosis Treated With Teriflunomide 14 mg Daily.
- ClinicalTrials.gov ID
- NCT04129736
- Acronym / sponsor ID
- TERIFL0519
- Conditions
- Multiple Sclerosis, Pharmacokinetics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Jan LyckeUniversity, hospital or other
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 17 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pharmacokinetic
| Arm | Type | Receives |
|---|---|---|
| Teriflunomide 14 mg tablets | Other | Drug: Teriflunomide 14 MGSingle arm |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with multiple sclerosis treated with teriflunomide 14 mg for at least 6 months
Key exclusion criteria (1 listed)
- other immunosuppressive or immunomodulating drugs, other CNS diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Teriflunomide 14 MGBlood and cerebrospinal fluid is obtained from teriflunomide treated patients with multiple sclerosis | Drug | Teriflunomide 14 mg tablets |
Primary outcome
Concentration of teriflunomide in cerebrospinal fluid
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2022.
- Individual participant dataSharing planned: No. No additional plan will be added
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Teriflunomide 14 MG in people with Multiple Sclerosis, Pharmacokinetics, run by Jan Lycke at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of teriflunomide in cerebrospinal fluid (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2022.