EpilepsyNCT02491073
Study to Evaluate Serum Free Thyroxine (FT4) and Free Triiodothyronine (FT3) Measurements for Subjects Treated With Eslicarbazeine Acetate (ESL)
An observational study of Epilepsy, run by Sumitomo Pharma America, Inc. at 7 sites in United States.
Trial summary
The purpose of this research study is to determine if the blood tests used to measure free thyroid hormone levels are affected by a drug called eslicarbazepine acetate. To determine if eslicarbazepine acetate interferes with these blood tests, blood samples will be analysed so that researchers can compare different… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Epilepsy
- What is being tested?
- blood draw
- How many people
- 71 participants
- Where
- 7 sitesUnited States
- Study dates
- Sep 2015to Mar 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Males and Females greater than or equal to 18 years of age, either exposed to drug or not exposed to drug
Who may be able to join
- ESL-exposed Subjects
- Subject must give written informed consent and privacy authorization prior to participation in the study.
- Male or female patient (≥ 18 years of age) who has received at least 1200 mg QD ESL for at least 6 weeks and has not experienced any rash or other allergic reaction at the time of blood draw.
- Non-ESL-exposed Subjects
- Subject must give written informed consent and privacy authorization prior to participation in the study.
- Male or female healthy normal volunteer (≥ 18 years of age).
Who cannot join
- Both ESL-exposed and non-ESL exposed subjects
- Subject who does not tolerate venipuncture or Has poor venous access that would cause difficulty for collecting blood samples.
- Subject with a history of thyroid disease or clinical condition (eg, renal insufficiency, Sjogren's syndrome, lupus, rheumatoid arthritis, pernicious anemia etc.) that in the opinion of the Investigator may effect levels of thyroid hormones, TBG, and/or TPO antibodies.
- Female subject who is pregnant.
- Female subject with a positive urine pregnancy test at screening.
- Subject who received any excluded medication for at least 30 days prior to blood draw.
Show all 10Show fewer
- Subject has experienced significant blood loss and/or donated blood within last 60 days of blood draw.
- Subject intends to donate blood or undergo elective surgery within next 30 days following blood draw.
- Subject has donated plasma within last 72 hours of blood draw or intends to donate plasma during study participation.
- Subject is, in the opinion of the Investigator, unsuitable in any other way to participate in the study.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Mid-Atlantic Epilepsy Center
Bethesda, Maryland, 20817
Consultans in Epilepsy & Neurology, PLLC
Boise, Idaho, 83702
NeurologicalClinic of Texas, P.A.
Dallas, Texas, 75251
Minneapolis Clinic of Neurology
Golden Valley, Minnesota, 55422
Bluegrass Epilepsy Research
Lexington, Kentucky, 40504
CliniLabs
New York, New York, 10019
The More foundation/The Core Institute
Sun City, Arizona, 85351
About this study
Official title: Ex-vivo Study to Evaluate Serum Free Thyroxine (FT4) and Free Triiodothyronine (FT3) Measurements Using Equilibrium Dialysis (ED) and Automated Kit Assay for Subjects Treated With Eslicarbazeine Acetate
The purpose of this research study is to determine if the blood tests used to measure free thyroid hormone levels are affected by a drug called eslicarbazepine acetate. To determine if eslicarbazepine acetate interferes with these blood tests, blood samples will be analysed so that researchers can compare different types of lab tests that measure these thyroid hormones. Half of the people who participate in this study will already be taking eslicarbazepine acetate either as a study drug or as a prescription (Part 1) and the other half will be people who do not take eslicarbazepine acetate (Part 2).
Read the detailed description
Part 1 of the study will enroll a minimum of 30 male and female subjects who have received at least 1200 mg once daily (QD) ESL over a minimum 6-week period (ESL-exposed subjects). Subjects, who meet study eligibility requirements and provide written consent, will provide blood samples for measurement of thyroid hormones, thyroxine binding globulins (TBG), serum pregnancy (female subjects of childbearing potential 1only), thyroid peroxidase (TPO) antibodies, and ESL metabolites (eslicarbazepine and (R)-licarbazepine).
Optional blood samples will be requested from subjects in Part 1 who provide genetic consent and are eligible to participate (as controls) in a separate rash registry protocol. These samples will be tested for HLA typing, genetic ancestry, and viral titers (including human herpes virus [HHV]-6, HHV-7, and Epstein-Barr virus [EBV]).
ESL metabolites will be determined by a validated liquid chromatography- tandem mass spectrometry (LC-MS/MS) assay. Levels of FT4 and FT3 in ESL-exposed serum will be assayed using the automated kit assay (Roche Cobas ECLIA kits FT4 II and FT3 III) and Equilibrium Dialysis (ED) method. FT4 and FT3 results measured by both methods will be compared to evaluate potential assay differences. Serum TSH, TT4, TT3, and TBG in ESL treated subject samples will also be measured using automated kit assays.
Part 2 of the study will enroll a minimum of 30 age (± 5 y) and gender-matched non-ESL exposed volunteers. Subjects, who meet study eligibility requirements and provide written consent, will provide a blood sample for measurement of thyroid hormones, TBG, serum pregnancy (female subjects of childbearing potential only), and TPO antibodies. Serum samples obtained from non-ESL exposed subjects will be split into 4 aliquots, one aliquot will be used as the control blank (unspiked) and the rest spiked with 3 levels (high, low, and a concentration representative of therapeutic levels also called middle) of eslicarbazepine (range approximately 5 to 18 μg/mL) and (R)-licarbazepine (range approximately 0.5 to 1.8 μg/mL). The low concentration for spiking the non-ESL exposed samples will be approximately 1 standard deviation (SD) below Cavg associated with the 800 mg dose in chronic use in the epilepsy population and the high concentration for spiking will be approximately 1 SD above Cavg associated with the 1200 mg dose.
After sample is spiked with eslicarbazepine and (R)-licarbazepine, serum FT4 and FT3 will be measured by the automated kit assay method, as well as ED method. FT4 and FT3 measured in non-spiked and spiked volunteer samples will be compared to detect potential in vitro artifacts. Serum TSH, TT4, TT3, and TBG in non-spiked and spiked volunteer samples will also be measured using automated kit assays.
- Conditions
- Epilepsy
- Being tested
- blood draw
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood drawOther
Investigate the possibility of assay artifacts impacting the measurement of thyroid hormones, in particular FT4 and FT3, in ESL treated subjects compared to non-ESL-treated subjects.
| Study group | Role | What they receive |
|---|---|---|
| Eslicarbazepine acetate treated | Not described Receives: Other: blood draw | |
| Non-Eslicarbazepine acetate treated | Not described Receives: Other: blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Concentrations of Free Thyroid Hormones (FT4 and FT3) as Measured by ED and Automated Kit Assay Method in ESL-exposed Subjects
Measured: 1 day
Comparison of Concentrations of Free Thyroid Hormones (FT4 and FT3) as Measured by Automated Kit Assay in Non-ESL Exposed Subjects, With and Without the in Vitro Addition of Eslicarbazepine and (R)-Licarbazepine.
Measured: 1 day
Secondary outcomes (3)
Comparison of Concentrations of TT4, and TT3 as Measured in Non-ESL-exposed Subject Samples, With or Without the in Vitro Addition of Eslicarbazepine and (R)-Licarbazepine.
Measured: 1 day
Comparison of Concentrations of Free Thyroid Hormones (FT4 and FT3) in Spiked and Unspiked Volunteer Samples Using ED and Automated Kit Assay.
Measured: 1 day
Comparison of Concentrations of TSH,as Measured in Non-ESL-exposed Subject Samples, With or Without the in Vitro Addition of Eslicarbazepine and (R)-Licarbazepine.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2015 (estimated)
- Study startSep 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for EpilepsyStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- CNS Medical Director, Study chair, Sumitomo Pharma America, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02491073
- Sponsor's protocol ID
- SEP093-451
- Status last verified
- Feb 2018
- First submitted
- 2 Jul 2015
- Last updated
- 7 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ex-vivo Study to Evaluate Serum Free Thyroxine (FT4) and Free Triiodothyronine (FT3) Measurements Using Equilibrium Dialysis (ED) and Automated Kit Assay for Subjects Treated With Eslicarbazeine Acetate
- ClinicalTrials.gov ID
- NCT02491073
- Acronym / sponsor ID
- SEP093-451
- Conditions
- Epilepsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 7 Jul 2015 (estimated)
- Results
- Posted 5 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to determine if the blood tests used to measure free thyroid hormone levels are affected by a drug called eslicarbazepine acetate. To determine if eslicarbazepine acetate interferes with these blood tests, blood samples will be analysed so that researchers can compare different types of lab tests that measure these thyroid hormones. Half of the people who participate in this study will already be taking eslicarbazepine acetate either as a study drug or as a prescription (Part 1) and the other half will be people who do not take eslicarbazepine acetate (Part 2).
Detailed description
Part 1 of the study will enroll a minimum of 30 male and female subjects who have received at least 1200 mg once daily (QD) ESL over a minimum 6-week period (ESL-exposed subjects). Subjects, who meet study eligibility requirements and provide written consent, will provide blood samples for measurement of thyroid hormones, thyroxine binding globulins (TBG), serum pregnancy (female subjects of childbearing potential 1only), thyroid peroxidase (TPO) antibodies, and ESL metabolites (eslicarbazepine and (R)-licarbazepine).
Optional blood samples will be requested from subjects in Part 1 who provide genetic consent and are eligible to participate (as controls) in a separate rash registry protocol. These samples will be tested for HLA typing, genetic ancestry, and viral titers (including human herpes virus [HHV]-6, HHV-7, and Epstein-Barr virus [EBV]).
ESL metabolites will be determined by a validated liquid chromatography- tandem mass spectrometry (LC-MS/MS) assay. Levels of FT4 and FT3 in ESL-exposed serum will be assayed using the automated kit assay (Roche Cobas ECLIA kits FT4 II and FT3 III) and Equilibrium Dialysis (ED) method. FT4 and FT3 results measured by both methods will be compared to evaluate potential assay differences. Serum TSH, TT4, TT3, and TBG in ESL treated subject samples will also be measured using automated kit assays.
Part 2 of the study will enroll a minimum of 30 age (± 5 y) and gender-matched non-ESL exposed volunteers. Subjects, who meet study eligibility requirements and provide written consent, will provide a blood sample for measurement of thyroid hormones, TBG, serum pregnancy (female subjects of childbearing potential only), and TPO antibodies. Serum samples obtained from non-ESL exposed subjects will be split into 4 aliquots, one aliquot will be used as the control blank (unspiked) and the rest spiked with 3 levels (high, low, and a concentration representative of therapeutic levels also called middle) of eslicarbazepine (range approximately 5 to 18 μg/mL) and (R)-licarbazepine (range approximately 0.5 to 1.8 μg/mL). The low concentration for spiking the non-ESL exposed samples will be approximately 1 standard deviation (SD) below Cavg associated with the 800 mg dose in chronic use in the epilepsy population and the high concentration for spiking will be approximately 1 SD above Cavg associated with the 1200 mg dose.
After sample is spiked with eslicarbazepine and (R)-licarbazepine, serum FT4 and FT3 will be measured by the automated kit assay method, as well as ED method. FT4 and FT3 measured in non-spiked and spiked volunteer samples will be compared to detect potential in vitro artifacts. Serum TSH, TT4, TT3, and TBG in non-spiked and spiked volunteer samples will also be measured using automated kit assays.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eslicarbazepine acetate treated | – | Other: blood draw |
| Non-Eslicarbazepine acetate treated | – | Other: blood draw |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Males and Females greater than or equal to 18 years of age, either exposed to drug or not exposed to drug
Key inclusion criteria (6 listed)
- ESL-exposed Subjects
- Non-ESL-exposed Subjects
Key exclusion criteria (10 listed)
- Both ESL-exposed and non-ESL exposed subjects
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 |
|---|---|---|
| blood drawInvestigate the possibility of assay artifacts impacting the measurement of thyroid hormones, in particular FT4 and FT3, in ESL treated subjects compared to non-ESL-treated subjects. | Other | Eslicarbazepine acetate treated, Non-Eslicarbazepine acetate treated |
Primary outcome
Comparison of Concentrations of Free Thyroid Hormones (FT4 and FT3) as Measured by ED and Automated Kit Assay Method in ESL-exposed Subjects
Time frame: 1 day
Comparison of Concentrations of Free Thyroid Hormones (FT4 and FT3) as Measured by Automated Kit Assay in Non-ESL Exposed Subjects, With and Without the in Vitro Addition of Eslicarbazepine and (R)-Licarbazepine.
Time frame: 1 day
3 secondary outcomes
Comparison of Concentrations of TT4, and TT3 as Measured in Non-ESL-exposed Subject Samples, With or Without the in Vitro Addition of Eslicarbazepine and (R)-Licarbazepine.
Time frame: 1 day
Comparison of Concentrations of Free Thyroid Hormones (FT4 and FT3) in Spiked and Unspiked Volunteer Samples Using ED and Automated Kit Assay.
Time frame: 1 day
Comparison of Concentrations of TSH,as Measured in Non-ESL-exposed Subject Samples, With or Without the in Vitro Addition of Eslicarbazepine and (R)-Licarbazepine.
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
CNS Medical Director study chair
Sumitomo Pharma America, Inc.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by Sumitomo Pharma America, Inc. at 7 sites in United States.
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 6 inclusion and 10 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 7 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Comparison of Concentrations of Free Thyroid Hormones (FT4 and FT3) as Measured by ED and Automated Kit Assay Method in ESL-exposed Subjects (time frame: 1 day). The study lists 2 primary outcomes in all. 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 7 Feb 2018.