N/A
N=71
Study to Evaluate Serum Free Thyroxine (FT4) and Free Triiodothyronine (FT3) Measurements for Subjects Treated With Eslicarbazeine Acetate (ESL)
Epilepsy
Bottom Line
View on ClinicalTrials.gov: NCT02491073 ↗Enrolled (actual)
71
Serious AEs
0.0%
Results posted
Feb 2018
Primary outcome: Primary: Comparison of Concentrations of Free Thyroid Hormones (FT4 and FT3) as Measured by ED and Automated Kit Assay Method in ESL-exposed Subjects — 12.29; 11.74; 4.20; 3.65 pmol/L — p=1.05
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- blood draw (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sumitomo Pharma America, Inc.
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison of Concentrations of Free Thyroid Hormones (FT4 and FT3) as Measured by ED and Automated Kit Assay Method in ESL-exposed Subjects |
12.29; 11.74; 4.20; 3.65 | 1.05 |
| PRIMARY 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. |
15.64; 15.84; 16.15; 16.49; 4.92; 4.95 | — |
| SECONDARY 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. |
94.82; 95.10; 96.06; 94.82; 1.69; 1.68 | — |
| SECONDARY Comparison of Concentrations of Free Thyroid Hormones (FT4 and FT3) in Spiked and Unspiked Volunteer Samples Using ED and Automated Kit Assay. |
15.64; 14.08; 15.84; 13.99; 16.15; 14.57 | — |
| SECONDARY 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. |
1.32; 1.33; 1.32; 1.33 | — |
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 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).
Eligibility Criteria
Inclusion Criteria
- 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).
Exclusion Criteria
- 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.
- 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.
Data sourced from ClinicalTrials.gov (NCT02491073). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.