Trial Outcomes & Findings for Study to Evaluate Serum Free Thyroxine (FT4) and Free Triiodothyronine (FT3) Measurements for Subjects Treated With Eslicarbazeine Acetate (ESL) (NCT NCT02491073)
NCT ID: NCT02491073
Last Updated: 2018-02-07
Results Overview
Recruitment status
COMPLETED
Target enrollment
71 participants
Primary outcome timeframe
1 day
Results posted on
2018-02-07
Participant Flow
Participant milestones
| Measure |
Eslicarbazepine Acetate Exposed Subjects
Adult male and female subjects (greater than or equal to 18 years)who had received at least 1200 mg QD eslicarbazapine acetate (ESL) for at least 6 weeks and had not experienced any rash or other allergic reaction at the time of the blood draw
|
Healthy Volunteers
Adult male and female healthy volunteer (greater than or equal to 18 years) not exposed to ESL at the time of blood draw
|
|---|---|---|
|
Overall Study
STARTED
|
37
|
34
|
|
Overall Study
COMPLETED
|
36
|
34
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Eslicarbazepine Acetate Exposed Subjects
Adult male and female subjects (greater than or equal to 18 years)who had received at least 1200 mg QD eslicarbazapine acetate (ESL) for at least 6 weeks and had not experienced any rash or other allergic reaction at the time of the blood draw
|
Healthy Volunteers
Adult male and female healthy volunteer (greater than or equal to 18 years) not exposed to ESL at the time of blood draw
|
|---|---|---|
|
Overall Study
screen failure
|
1
|
0
|
Baseline Characteristics
Study to Evaluate Serum Free Thyroxine (FT4) and Free Triiodothyronine (FT3) Measurements for Subjects Treated With Eslicarbazeine Acetate (ESL)
Baseline characteristics by cohort
| Measure |
Eslicarbazepine Acetate Treated
n=31 Participants
blood draw: 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.
|
Non-Eslicarbazepine Acetate Treated
n=31 Participants
blood draw: 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.
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=39 Participants
|
28 Participants
n=41 Participants
|
56 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
|
Age, Continuous
|
41.8 years
STANDARD_DEVIATION 14.95 • n=39 Participants
|
41.7 years
STANDARD_DEVIATION 14.64 • n=41 Participants
|
41.8 years
STANDARD_DEVIATION 14.68 • n=35 Participants
|
|
Age, Customized
<18 years of age
|
0 participants
n=39 Participants
|
0 participants
n=41 Participants
|
0 participants
n=35 Participants
|
|
Age, Customized
18-39 Years
|
16 participants
n=39 Participants
|
16 participants
n=41 Participants
|
32 participants
n=35 Participants
|
|
Age, Customized
40-65 Years
|
13 participants
n=39 Participants
|
13 participants
n=41 Participants
|
26 participants
n=35 Participants
|
|
Age, Customized
>65 Years
|
2 participants
n=39 Participants
|
2 participants
n=41 Participants
|
4 participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=39 Participants
|
16 Participants
n=41 Participants
|
32 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=39 Participants
|
15 Participants
n=41 Participants
|
30 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=39 Participants
|
27 Participants
n=41 Participants
|
56 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=39 Participants
|
20 Participants
n=41 Participants
|
23 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
32 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=39 Participants
|
31 participants
n=41 Participants
|
62 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 1 dayPopulation: Safety Population: The safety population consisted of all subjects who were enrolled in the study, did not test positive for serum pregnancy (female subjects of childbearing potential only) or TPO antibodies, and provided valid serum samples for evaluating the thyroid hormone assays
Outcome measures
| Measure |
Automated Kit Assay (AK) - ESL-exposed Subjects
n=31 Participants
Free thyroid hormone level in the serum sample of ESL-exposed subjects as measured by the automated kit assay
|
Optimized Equilibrium Dialysis Method (ED)ESL-exposed Subjects
n=31 Participants
Free thyroid hormone level in the serum sample of ESL-exposed subjects as measured by the optimized equilibrium dialysis method
|
Mid-spiked Serum(MS)Healthy Volunteers
Free thyroid hormone level in the serum sample of healthy volunteers which was spiked with medium level of ESL metabolites
|
High-spiked Serum(HS)Healthy Volunteers
Free thyroid hormone level in the serum sample of healthy volunteers which was spiked with high level of ESL metabolites
|
Automated Kit Assay(AK)Med-spikedSerum(MS)Healthy Volunteers
Free thyroid hormone level as measured by the automated kit assay in the serum sample of healthy volunteers which was spiked with medium level of ESL metabolites
|
Optimized Equilibrium Dialysis Method(ED)(MS)Healthyvolunteer
Free thyroid hormone level as measured by the optimized equilibrium dialysis method in the serum sample of healthy volunteers which was spiked with medium level of ESL metabolites
|
Automated Kit Assay(AK)High-spikedSerum(HS)Healthy Volunteers
Free thyroid hormone level as measured by the automated kit assay in the serum sample of healthy volunteers which was spiked with high level of ESL metabolites
|
Optimized Equilibrium Dialysis Method(ED)(HS)Healthyvolunteer
Free thyroid hormone level as measured by the optimized equilibrium dialysis method in the serum sample of healthy volunteers which was spiked with high level of ESL metabolites
|
|---|---|---|---|---|---|---|---|---|
|
Comparison of Concentrations of Free Thyroid Hormones (FT4 and FT3) as Measured by ED and Automated Kit Assay Method in ESL-exposed Subjects
FT4: pmol/L
|
12.29 pmol/L
Geometric Coefficient of Variation 0.139
|
11.74 pmol/L
Geometric Coefficient of Variation 0.244
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Comparison of Concentrations of Free Thyroid Hormones (FT4 and FT3) as Measured by ED and Automated Kit Assay Method in ESL-exposed Subjects
FT3: pmol/L
|
4.20 pmol/L
Geometric Coefficient of Variation 0.112
|
3.65 pmol/L
Geometric Coefficient of Variation 0.183
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 dayPopulation: Safety Population: The safety population consisted of all subjects who were enrolled in the study, did not test positive for serum pregnancy (female subjects of childbearing potential only) or TPO antibodies, and provided valid serum samples for evaluating the thyroid hormone assays
Outcome measures
| Measure |
Automated Kit Assay (AK) - ESL-exposed Subjects
n=31 Participants
Free thyroid hormone level in the serum sample of ESL-exposed subjects as measured by the automated kit assay
|
Optimized Equilibrium Dialysis Method (ED)ESL-exposed Subjects
n=31 Participants
Free thyroid hormone level in the serum sample of ESL-exposed subjects as measured by the optimized equilibrium dialysis method
|
Mid-spiked Serum(MS)Healthy Volunteers
n=31 Participants
Free thyroid hormone level in the serum sample of healthy volunteers which was spiked with medium level of ESL metabolites
|
High-spiked Serum(HS)Healthy Volunteers
n=31 Participants
Free thyroid hormone level in the serum sample of healthy volunteers which was spiked with high level of ESL metabolites
|
Automated Kit Assay(AK)Med-spikedSerum(MS)Healthy Volunteers
Free thyroid hormone level as measured by the automated kit assay in the serum sample of healthy volunteers which was spiked with medium level of ESL metabolites
|
Optimized Equilibrium Dialysis Method(ED)(MS)Healthyvolunteer
Free thyroid hormone level as measured by the optimized equilibrium dialysis method in the serum sample of healthy volunteers which was spiked with medium level of ESL metabolites
|
Automated Kit Assay(AK)High-spikedSerum(HS)Healthy Volunteers
Free thyroid hormone level as measured by the automated kit assay in the serum sample of healthy volunteers which was spiked with high level of ESL metabolites
|
Optimized Equilibrium Dialysis Method(ED)(HS)Healthyvolunteer
Free thyroid hormone level as measured by the optimized equilibrium dialysis method in the serum sample of healthy volunteers which was spiked with high level of ESL metabolites
|
|---|---|---|---|---|---|---|---|---|
|
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.
FT4: pmo/L
|
15.64 pmol/L
Geometric Coefficient of Variation 0.146
|
15.84 pmol/L
Geometric Coefficient of Variation 0.147
|
16.15 pmol/L
Geometric Coefficient of Variation 0.146
|
16.49 pmol/L
Geometric Coefficient of Variation 0.145
|
—
|
—
|
—
|
—
|
|
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.
FT3: pmo/L
|
4.92 pmol/L
Geometric Coefficient of Variation 0.125
|
4.95 pmol/L
Geometric Coefficient of Variation 0.128
|
5.00 pmol/L
Geometric Coefficient of Variation 0.133
|
5.06 pmol/L
Geometric Coefficient of Variation 0.122
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 dayPopulation: Safety Population: The safety population consisted of all subjects who were enrolled in the study, did not test positive for serum pregnancy (female subjects of childbearing potential only) or TPO antibodies, and provided valid serum samples for evaluating the thyroid hormone assays
Outcome measures
| Measure |
Automated Kit Assay (AK) - ESL-exposed Subjects
n=31 Participants
Free thyroid hormone level in the serum sample of ESL-exposed subjects as measured by the automated kit assay
|
Optimized Equilibrium Dialysis Method (ED)ESL-exposed Subjects
n=31 Participants
Free thyroid hormone level in the serum sample of ESL-exposed subjects as measured by the optimized equilibrium dialysis method
|
Mid-spiked Serum(MS)Healthy Volunteers
n=31 Participants
Free thyroid hormone level in the serum sample of healthy volunteers which was spiked with medium level of ESL metabolites
|
High-spiked Serum(HS)Healthy Volunteers
n=31 Participants
Free thyroid hormone level in the serum sample of healthy volunteers which was spiked with high level of ESL metabolites
|
Automated Kit Assay(AK)Med-spikedSerum(MS)Healthy Volunteers
Free thyroid hormone level as measured by the automated kit assay in the serum sample of healthy volunteers which was spiked with medium level of ESL metabolites
|
Optimized Equilibrium Dialysis Method(ED)(MS)Healthyvolunteer
Free thyroid hormone level as measured by the optimized equilibrium dialysis method in the serum sample of healthy volunteers which was spiked with medium level of ESL metabolites
|
Automated Kit Assay(AK)High-spikedSerum(HS)Healthy Volunteers
Free thyroid hormone level as measured by the automated kit assay in the serum sample of healthy volunteers which was spiked with high level of ESL metabolites
|
Optimized Equilibrium Dialysis Method(ED)(HS)Healthyvolunteer
Free thyroid hormone level as measured by the optimized equilibrium dialysis method in the serum sample of healthy volunteers which was spiked with high level of ESL metabolites
|
|---|---|---|---|---|---|---|---|---|
|
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.
TT4: nmo/L
|
94.82 nmo/L
Geometric Coefficient of Variation 0.177
|
95.10 nmo/L
Geometric Coefficient of Variation 0.173
|
96.06 nmo/L
Geometric Coefficient of Variation 0.169
|
94.82 nmo/L
Geometric Coefficient of Variation 0.165
|
—
|
—
|
—
|
—
|
|
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.
TT#: nmo/L
|
1.69 nmo/L
Geometric Coefficient of Variation 0.158
|
1.68 nmo/L
Geometric Coefficient of Variation 0.158
|
1.68 nmo/L
Geometric Coefficient of Variation 0.160
|
1.67 nmo/L
Geometric Coefficient of Variation 0.161
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 dayPopulation: Safety Population: The safety population consisted of all subjects who were enrolled in the study, did not test positive for serum pregnancy (female subjects of childbearing potential only) or TPO antibodies, and provided valid serum samples for evaluating the thyroid hormone assays
Outcome measures
| Measure |
Automated Kit Assay (AK) - ESL-exposed Subjects
n=31 Participants
Free thyroid hormone level in the serum sample of ESL-exposed subjects as measured by the automated kit assay
|
Optimized Equilibrium Dialysis Method (ED)ESL-exposed Subjects
n=31 Participants
Free thyroid hormone level in the serum sample of ESL-exposed subjects as measured by the optimized equilibrium dialysis method
|
Mid-spiked Serum(MS)Healthy Volunteers
n=31 Participants
Free thyroid hormone level in the serum sample of healthy volunteers which was spiked with medium level of ESL metabolites
|
High-spiked Serum(HS)Healthy Volunteers
n=31 Participants
Free thyroid hormone level in the serum sample of healthy volunteers which was spiked with high level of ESL metabolites
|
Automated Kit Assay(AK)Med-spikedSerum(MS)Healthy Volunteers
n=31 Participants
Free thyroid hormone level as measured by the automated kit assay in the serum sample of healthy volunteers which was spiked with medium level of ESL metabolites
|
Optimized Equilibrium Dialysis Method(ED)(MS)Healthyvolunteer
n=31 Participants
Free thyroid hormone level as measured by the optimized equilibrium dialysis method in the serum sample of healthy volunteers which was spiked with medium level of ESL metabolites
|
Automated Kit Assay(AK)High-spikedSerum(HS)Healthy Volunteers
n=31 Participants
Free thyroid hormone level as measured by the automated kit assay in the serum sample of healthy volunteers which was spiked with high level of ESL metabolites
|
Optimized Equilibrium Dialysis Method(ED)(HS)Healthyvolunteer
n=31 Participants
Free thyroid hormone level as measured by the optimized equilibrium dialysis method in the serum sample of healthy volunteers which was spiked with high level of ESL metabolites
|
|---|---|---|---|---|---|---|---|---|
|
Comparison of Concentrations of Free Thyroid Hormones (FT4 and FT3) in Spiked and Unspiked Volunteer Samples Using ED and Automated Kit Assay.
FT4 pmol/L
|
15.64 pmol/L
Geometric Coefficient of Variation 0.146
|
14.08 pmol/L
Geometric Coefficient of Variation 0.193
|
15.84 pmol/L
Geometric Coefficient of Variation 0.147
|
13.99 pmol/L
Geometric Coefficient of Variation 0.204
|
16.15 pmol/L
Geometric Coefficient of Variation 0.146
|
14.57 pmol/L
Geometric Coefficient of Variation 0.254
|
16.49 pmol/L
Geometric Coefficient of Variation 0.145
|
15.80 pmol/L
Geometric Coefficient of Variation 0.232
|
|
Comparison of Concentrations of Free Thyroid Hormones (FT4 and FT3) in Spiked and Unspiked Volunteer Samples Using ED and Automated Kit Assay.
FT3 pmol/L
|
4.92 pmol/L
Geometric Coefficient of Variation 0.125
|
4.06 pmol/L
Geometric Coefficient of Variation 0.192
|
4.95 pmol/L
Geometric Coefficient of Variation 0.128
|
3.47 pmol/L
Geometric Coefficient of Variation 0.273
|
5.00 pmol/L
Geometric Coefficient of Variation 0.133
|
4.20 pmol/L
Geometric Coefficient of Variation 0.208
|
5.06 pmol/L
Geometric Coefficient of Variation 0.122
|
4.27 pmol/L
Geometric Coefficient of Variation 0.246
|
SECONDARY outcome
Timeframe: 1 dayPopulation: Safety Population: The safety population consisted of all subjects who were enrolled in the study, did not test positive for serum pregnancy (female subjects of childbearing potential only) or TPO antibodies, and provided valid serum samples for evaluating the thyroid hormone assays
Outcome measures
| Measure |
Automated Kit Assay (AK) - ESL-exposed Subjects
n=31 Participants
Free thyroid hormone level in the serum sample of ESL-exposed subjects as measured by the automated kit assay
|
Optimized Equilibrium Dialysis Method (ED)ESL-exposed Subjects
n=31 Participants
Free thyroid hormone level in the serum sample of ESL-exposed subjects as measured by the optimized equilibrium dialysis method
|
Mid-spiked Serum(MS)Healthy Volunteers
n=31 Participants
Free thyroid hormone level in the serum sample of healthy volunteers which was spiked with medium level of ESL metabolites
|
High-spiked Serum(HS)Healthy Volunteers
n=31 Participants
Free thyroid hormone level in the serum sample of healthy volunteers which was spiked with high level of ESL metabolites
|
Automated Kit Assay(AK)Med-spikedSerum(MS)Healthy Volunteers
Free thyroid hormone level as measured by the automated kit assay in the serum sample of healthy volunteers which was spiked with medium level of ESL metabolites
|
Optimized Equilibrium Dialysis Method(ED)(MS)Healthyvolunteer
Free thyroid hormone level as measured by the optimized equilibrium dialysis method in the serum sample of healthy volunteers which was spiked with medium level of ESL metabolites
|
Automated Kit Assay(AK)High-spikedSerum(HS)Healthy Volunteers
Free thyroid hormone level as measured by the automated kit assay in the serum sample of healthy volunteers which was spiked with high level of ESL metabolites
|
Optimized Equilibrium Dialysis Method(ED)(HS)Healthyvolunteer
Free thyroid hormone level as measured by the optimized equilibrium dialysis method in the serum sample of healthy volunteers which was spiked with high level of ESL metabolites
|
|---|---|---|---|---|---|---|---|---|
|
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 mU/L
Geometric Coefficient of Variation 0.566
|
1.33 mU/L
Geometric Coefficient of Variation 0.563
|
1.32 mU/L
Geometric Coefficient of Variation 0.569
|
1.33 mU/L
Geometric Coefficient of Variation 0.565
|
—
|
—
|
—
|
—
|
Adverse Events
Eslicarbazepine Acetate Exposed Subjects
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Healthy Volunteers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Eslicarbazepine Acetate Exposed Subjects
n=37 participants at risk
Adult male and female subjects (greater than or equal to 18 years)who had received at least 1200 mg QD eslicarbazapine acetate (ESL) for at least 6 weeks and had not experienced any rash or other allergic reaction at the time of the blood draw
|
Healthy Volunteers
n=34 participants at risk
Adult male and female healthy volunteer (greater than or equal to 18 years) not exposed to ESL at the time of blood draw
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
2.7%
1/37 • Number of events 1 • One day
Adverse events were collected on the same day as the study visit
|
0.00%
0/34 • One day
Adverse events were collected on the same day as the study visit
|
Additional Information
CNS Medical Director
Sunovion Pharmaceuticals Inc.
Phone: 1-866-503-6351
Results disclosure agreements
- Principal investigator is a sponsor employee In the event the study is part of a multi-center study, the first publication of the results of the study shall be made in conjunction with the results of other participating study sites as a multi-center publication; provided however, if a multi-center publication is not forthcoming within twenty-four (24) months following completion of the study at all sites, institution and investigator shall be free to publish
- Publication restrictions are in place
Restriction type: OTHER