Study to Evaluate Serum Free Thyroxine (FT4) and Free Triiodothyronine (FT3) Measurements for Subjects Treated With Eslicarbazeine Acetate (ESL)

Completed

Conditions studied: Epilepsy

In brief

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).

Key facts

Study ID: NCT02491073
Run by: Sumitomo Pharma America, Inc.
People needed: 71
Starts: 2015-09-01
Expected to finish: 2016-03-01
Last updated by the study team: 2018-02-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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).

You may not qualify if…

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.

Where it is running

The More foundation/The Core Institute — Sun City, Arizona, United States
Consultans in Epilepsy & Neurology, PLLC — Boise, Idaho, United States
Bluegrass Epilepsy Research — Lexington, Kentucky, United States
Mid-Atlantic Epilepsy Center — Bethesda, Maryland, United States
Minneapolis Clinic of Neurology — Golden Valley, Minnesota, United States
CliniLabs — New York, New York, United States
NeurologicalClinic of Texas, P.A. — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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