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

NCT02491073 | Completed Results

• 1 other identifier: SEP093-451
• Study Type: observational
• Target: 71
• Locations: 1 country
• Sites: 7

Brief 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).

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (2)

• Comparison of Concentrations of Free Thyroid Hormones (FT4 and FT3) as Measured by ED and Automated Kit Assay Method in ESL-exposed Subjects

  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.

  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.

  1 day

• Comparison of Concentrations of Free Thyroid Hormones (FT4 and FT3) in Spiked and Unspiked Volunteer Samples Using ED and Automated Kit Assay.

  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.

  1 day

Study Arms (2)

Eslicarbazepine acetate treated

Other: blood draw

Non-Eslicarbazepine acetate treated

Other: blood draw

Interventions

blood draw OTHER

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.

Eslicarbazepine acetate treated; Non-Eslicarbazepine acetate treated

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Males and Females greater than or equal to 18 years of age, either exposed to drug or not exposed to drug

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.

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead

Study Sites (7)

The More foundation/The Core Institute

Sun City, Arizona, 85351, United States

Location

Consultans in Epilepsy & Neurology, PLLC

Boise, Idaho, 83702, United States

Location

Bluegrass Epilepsy Research

Lexington, Kentucky, 40504, United States

Location

Mid-Atlantic Epilepsy Center

Bethesda, Maryland, 20817, United States

Location

Minneapolis Clinic of Neurology

Golden Valley, Minnesota, 55422, United States

Location

CliniLabs

New York, New York, 10019, United States

Location

NeurologicalClinic of Texas, P.A.

Dallas, Texas, 75251, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Conditions

Epilepsy

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: CNS Medical Director
• Organization: Sunovion Pharmaceuticals Inc.

1-866-503-6351

Study Officials

• CNS Medical Director

  Sumitomo Pharma America, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2015
• First Posted: July 7, 2015
• Study Start: September 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: February 7, 2018
• Results First Posted: February 5, 2018

Record last verified: 2018-02

Locations

US (7)