Epilepsy, Partial
Conditions
Keywords
Vimpat, Partial seizures, Carbamazepine, Hormone levels, Lipid levels, Lacosamide
Brief summary
The purpose of the trial is to investigate whether changes in lipids and hormonal parameters can be observed in blood when Carbamazepine treatment is replaced with Lacosamide treatment, while Levetiracetam treatment remains unchanged.
Interventions
DRUGLacosamide
4-Week Titration Period: start dose Lacosamide (LCM) is 100 mg/day - up-titration of 100 mg/week LCM 8-Week Maintenance Period: dose can change first 4 weeks with 100 mg/week, must remain between 300 mg/day and 600 mg/day. Dose must remain stable last 4 weeks.
DRUGLevetiracetam
Levetiracetam (LEV) is taken at a stable dose 30 days before study entry and is ≥ 1000 mg/day at the first visit. The LEV dose may not be changed at any time.
Sponsors
UCB Pharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Male subject with diagnosis of Epilepsy with Partial-Onset Seizures * Subject only taking Levetiracetam in combination with Carbamazepine as adjunctive treatment for Epilepsy
Exclusion criteria
* Subject is taking another Anti-Epileptic Drug (AED) than Carbamazepine (CBZ) and Levetiracetam (LEV) * Subject is taking lipid lowering agents * Subject is taking enzyme inducers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Serum Sex Hormone Binding Globulin (SHBG) From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period) | From Day 1 (Baseline) to Day 84 (Treatment Period End) | Due to premature termination of enrollment prior to achieving the planned sample size (a total of 28 subjects), this primary safety variable was assessed for descriptive purposes only. A negative value indicates an improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Sex Hormone Calculated Free Androgen Index Levels From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period) | From Day 1 (Baseline) to Day 84 (Treatment Period End) | The change in sex hormone calculated free androgen index (100 x Testosterone/sex hormone binding globulin) levels from Baseline to the end of Maintenance Period was summarized descriptively by visit. A negative value indicates an improvement. |
| Change in Serum Thyroid Hormone Free Thyroxine Level From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period) | From Day 1 (Baseline) to Day 84 (Treatment Period End) | The change in the serum thyroid hormone free thyroxine level from Baseline to the end of the Maintenance Period was summarized descriptively by visit. |
| Change in Total Cholesterol Level From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period) | From Day 1 (Baseline) to Day 84 (Treatment Period End) | The change in total cholesterol levels from Baseline to the end of the Maintenance Period was summarized descriptively by visit. A negative value indicates an improvement. |
Countries
Austria, Germany, Spain
Participant flow
Recruitment details
The study was conducted at 5 sites across Austria (1 site), Germany (3 sites), and Spain (1 site).
Pre-assignment details
The study consisted of a 1-week Screening Period, a 12-week Treatment Period (comprised of a 4-week Titration Period and an 8-week Maintenance Period), and a Taper/Safety Follow-Up Period 3 to 4 weeks in duration.
Participants by arm
| Arm | Count |
|---|---|
| Lacosamide commercial 50 mg (pinkish) and 100 mg (yellow) tablets
* Lacosamide: 4-week Titration Period: start dose Lacosamide (LCM) was 100 mg/day - up-titration of 100 mg/week LCM.
8-week Maintenance Period: dose could change first 4 weeks with 100 mg/week, needed to remain between 300 mg/day and 600 mg/day. Dose needed to remain stable last 4 weeks.
* Levetiracetam: Levetiracetam (LEV) was taken at a stable dose 30 days before study entry and was ≥ 1000 mg/day at the first visit. The LEV dose could not be changed at any time. | 11 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
Baseline characteristics
| Characteristic | Lacosamide |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants |
| Age, Continuous | 31.5 years STANDARD_DEVIATION 5.9 |
| Body Mass Index | 25.89 kilogram per square meter STANDARD_DEVIATION 3.01 |
| Height | 178.05 centimeters STANDARD_DEVIATION 10.14 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 participants |
| Race/Ethnicity, Customized Asian | 0 participants |
| Race/Ethnicity, Customized Black or African American | 0 participants |
| Race/Ethnicity, Customized Native Hawaiin or other Pacific Islander | 0 participants |
| Race/Ethnicity, Customized Other/Mixed | 1 participants |
| Race/Ethnicity, Customized White | 9 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 11 Participants |
| Weight | 82.81 kilograms STANDARD_DEVIATION 16.25 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 5 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
Primary
Change in Serum Sex Hormone Binding Globulin (SHBG) From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period)
Due to premature termination of enrollment prior to achieving the planned sample size (a total of 28 subjects), this primary safety variable was assessed for descriptive purposes only. A negative value indicates an improvement.
Time frame: From Day 1 (Baseline) to Day 84 (Treatment Period End)
Population: The Analysis Population refers to the Safety Set (SS). The SS consists of all subjects who received at least 1 dose of Lacosamide.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lacosamide | Change in Serum Sex Hormone Binding Globulin (SHBG) From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period) | -12.80 nmol/L |
Secondary
Change in Serum Thyroid Hormone Free Thyroxine Level From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period)
The change in the serum thyroid hormone free thyroxine level from Baseline to the end of the Maintenance Period was summarized descriptively by visit.
Time frame: From Day 1 (Baseline) to Day 84 (Treatment Period End)
Population: The Analysis Population refers to the Safety Set (SS). The SS consists of all subjects who received at least 1 dose of Lacosamide.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lacosamide | Change in Serum Thyroid Hormone Free Thyroxine Level From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period) | 2.70 pmol/L |
Secondary
Change in Sex Hormone Calculated Free Androgen Index Levels From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period)
The change in sex hormone calculated free androgen index (100 x Testosterone/sex hormone binding globulin) levels from Baseline to the end of Maintenance Period was summarized descriptively by visit. A negative value indicates an improvement.
Time frame: From Day 1 (Baseline) to Day 84 (Treatment Period End)
Population: The Analysis Population refers to the Safety Set (SS). The SS consists of all subjects who received at least 1 dose of Lacosamide.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lacosamide | Change in Sex Hormone Calculated Free Androgen Index Levels From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period) | 9.493 Free Androgen Index |
Secondary
Change in Total Cholesterol Level From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period)
The change in total cholesterol levels from Baseline to the end of the Maintenance Period was summarized descriptively by visit. A negative value indicates an improvement.
Time frame: From Day 1 (Baseline) to Day 84 (Treatment Period End)
Population: The Analysis Population refers to the Safety Set (SS). The SS consists of all subjects who received at least 1 dose of Lacosamide.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lacosamide | Change in Total Cholesterol Level From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period) | -0.540 mmol/L |