Trial Outcomes & Findings for Hormonal and Lipid Levels in Male Subjects After a Switch From Carbamazepine to Lacosamide (NCT NCT01375374)
NCT ID: NCT01375374
Last Updated: 2017-08-28
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
11 participants
Primary outcome timeframe
From Day 1 (Baseline) to Day 84 (Treatment Period End)
Results posted on
2017-08-28
Participant Flow
The study was conducted at 5 sites across Austria (1 site), Germany (3 sites), and Spain (1 site).
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Hormonal and Lipid Levels in Male Subjects After a Switch From Carbamazepine to Lacosamide
Baseline characteristics by cohort
| Measure |
Lacosamide
n=11 Participants
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.
|
|---|---|
|
Age, Continuous
|
31.5 years
STANDARD_DEVIATION 5.9 • n=99 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiin or other Pacific Islander
|
0 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White
|
9 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Other/Mixed
|
1 participants
n=99 Participants
|
|
Weight
|
82.81 kilograms
STANDARD_DEVIATION 16.25 • n=99 Participants
|
|
Height
|
178.05 centimeters
STANDARD_DEVIATION 10.14 • n=99 Participants
|
|
Body Mass Index
|
25.89 kilogram per square meter
STANDARD_DEVIATION 3.01 • n=99 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Lacosamide
n=10 Participants
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.
|
|---|---|
|
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
Interval -20.3 to 4.9
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Lacosamide
n=10 Participants
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.
|
|---|---|
|
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
Interval 2.39 to 26.46
|
SECONDARY outcome
Timeframe: 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.
The change in the serum thyroid hormone free thyroxine level from Baseline to the end of the Maintenance Period was summarized descriptively by visit.
Outcome measures
| Measure |
Lacosamide
n=10 Participants
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.
|
|---|---|
|
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
Interval 1.5 to 5.5
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Lacosamide
n=10 Participants
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.
|
|---|---|
|
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
Interval -1.46 to 0.11
|
Adverse Events
Lacosamide
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lacosamide
n=11 participants at risk
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.
|
|---|---|
|
General disorders
Fatigue
|
9.1%
1/11 • Number of events 1 • Treatment Emergent Adverse Event were reported from Baseline until the Safety Follow-up Visit (two weeks after end of Treatment Period).
Only Treatment Emergent Adverse Events are presented.
|
|
Infections and infestations
Bronchitis
|
9.1%
1/11 • Number of events 1 • Treatment Emergent Adverse Event were reported from Baseline until the Safety Follow-up Visit (two weeks after end of Treatment Period).
Only Treatment Emergent Adverse Events are presented.
|
|
Infections and infestations
Influenza
|
9.1%
1/11 • Number of events 1 • Treatment Emergent Adverse Event were reported from Baseline until the Safety Follow-up Visit (two weeks after end of Treatment Period).
Only Treatment Emergent Adverse Events are presented.
|
|
Nervous system disorders
Convulsion
|
9.1%
1/11 • Number of events 1 • Treatment Emergent Adverse Event were reported from Baseline until the Safety Follow-up Visit (two weeks after end of Treatment Period).
Only Treatment Emergent Adverse Events are presented.
|
|
Nervous system disorders
Disturbance in attention
|
9.1%
1/11 • Number of events 1 • Treatment Emergent Adverse Event were reported from Baseline until the Safety Follow-up Visit (two weeks after end of Treatment Period).
Only Treatment Emergent Adverse Events are presented.
|
|
Nervous system disorders
Paraesthesia
|
9.1%
1/11 • Number of events 1 • Treatment Emergent Adverse Event were reported from Baseline until the Safety Follow-up Visit (two weeks after end of Treatment Period).
Only Treatment Emergent Adverse Events are presented.
|
|
Nervous system disorders
Partial seizures
|
9.1%
1/11 • Number of events 1 • Treatment Emergent Adverse Event were reported from Baseline until the Safety Follow-up Visit (two weeks after end of Treatment Period).
Only Treatment Emergent Adverse Events are presented.
|
|
Nervous system disorders
Tremor
|
9.1%
1/11 • Number of events 1 • Treatment Emergent Adverse Event were reported from Baseline until the Safety Follow-up Visit (two weeks after end of Treatment Period).
Only Treatment Emergent Adverse Events are presented.
|
|
Psychiatric disorders
Aggression
|
9.1%
1/11 • Number of events 1 • Treatment Emergent Adverse Event were reported from Baseline until the Safety Follow-up Visit (two weeks after end of Treatment Period).
Only Treatment Emergent Adverse Events are presented.
|
|
Vascular disorders
Hot flush
|
9.1%
1/11 • Number of events 1 • Treatment Emergent Adverse Event were reported from Baseline until the Safety Follow-up Visit (two weeks after end of Treatment Period).
Only Treatment Emergent Adverse Events are presented.
|
Additional Information
UCB Clinical Trial Call Center
UCB
Phone: +1 877 822 9493
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60