Trial Outcomes & Findings for Randomized Controlled Trial to Assess Effects of Lacosamide on Sleep and Wake in Adults With Focal Epilepsy (NCT NCT01190098)
NCT ID: NCT01190098
Last Updated: 2016-12-05
Results Overview
Scale 0 - 24 Higher scores indicate more severe symptoms
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
59 participants
Primary outcome timeframe
Baseline and Visit 4 (approximately 1 - 2 months)
Results posted on
2016-12-05
Participant Flow
52 subjects randomized, 59 subjects enrolled. The 7 either were either screen failures or chose not to proceed with the study.
Participant milestones
| Measure |
Lacosamide
Lacosamide: Subjects randomized to lacosamide according to the following schedule:
Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid
|
Sugar Pill
Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
10
|
|
Overall Study
COMPLETED
|
39
|
8
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Lacosamide
Lacosamide: Subjects randomized to lacosamide according to the following schedule:
Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid
|
Sugar Pill
Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Patient coomorbidity
|
0
|
1
|
|
Overall Study
Lack of transportation
|
1
|
0
|
|
Overall Study
Other
|
0
|
1
|
Baseline Characteristics
Randomized Controlled Trial to Assess Effects of Lacosamide on Sleep and Wake in Adults With Focal Epilepsy
Baseline characteristics by cohort
| Measure |
Lacosamide
n=42 Participants
Lacosamide: Subjects randomized to lacosamide according to the following schedule:
Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid
|
Sugar Pill
n=10 Participants
Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
41 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Gender
Female
|
29 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Gender
Male
|
13 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=5 Participants
|
10 participants
n=7 Participants
|
52 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Visit 4 (approximately 1 - 2 months)Scale 0 - 24 Higher scores indicate more severe symptoms
Outcome measures
| Measure |
Lacosamide
n=39 Participants
Lacosamide: Subjects randomized to lacosamide according to the following schedule:
Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid
|
Sugar Pill
n=8 Participants
Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
|
|---|---|---|
|
Change in Epworth Sleepiness Scale Score From Baseline to Visit 4
|
-1.2 Units on a scale
Interval -2.9 to 0.53
|
-1.1 Units on a scale
Interval -5.2 to 3.0
|
SECONDARY outcome
Timeframe: Baseline to Visit 4 (approximately 1 - 2 months)Population: 6 subjects did not complete enough questions on the tool for the total score to be calculated at both time points.
Fatigue Severity Scale (FSS): Range 7- 63 where higher scores indicate more severe fatigue.
Outcome measures
| Measure |
Lacosamide
n=33 Participants
Lacosamide: Subjects randomized to lacosamide according to the following schedule:
Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid
|
Sugar Pill
n=8 Participants
Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
|
|---|---|---|
|
Change in the Fatigue Severity Scale From Baseline to Visit 4.
|
0.30 units on a scale
Interval -3.7 to 4.3
|
-5.4 units on a scale
Interval -17.1 to 6.4
|
SECONDARY outcome
Timeframe: Baseline to Visit 4 (approximately 1 - 2 months)Population: 7 subjects did not complete enough questions on the tool for the total score to be calculated at both time points.
Range 0-21, where higher scores more impairment (in terms of sleep quality).
Outcome measures
| Measure |
Lacosamide
n=34 Participants
Lacosamide: Subjects randomized to lacosamide according to the following schedule:
Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid
|
Sugar Pill
n=6 Participants
Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
|
|---|---|---|
|
Change in Pittsburgh Sleep Quality Inventory (PSQI) From Baseline to Visit 4
|
-1.6 units on a scale
Interval -2.9 to 0.0
|
-1.3 units on a scale
Interval -2.9 to 0.3
|
SECONDARY outcome
Timeframe: Baseline to visit 4 (approximately 1 - 2 months)Population: 5 subjects did not complete enough questions on the tool for the total score to be calculated at both time points.
Range 0-20 where lower scores indicate more impairment (sleep related QOL).
Outcome measures
| Measure |
Lacosamide
n=34 Participants
Lacosamide: Subjects randomized to lacosamide according to the following schedule:
Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid
|
Sugar Pill
n=8 Participants
Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
|
|---|---|---|
|
Change in Functional Outcomes of Sleep Questionnaire (FOSQ) From Baseline to Visit 4.
|
0.3 units on a scale
Interval 0.0 to 1.0
|
1.1 units on a scale
Interval -1.3 to 3.5
|
SECONDARY outcome
Timeframe: Baseline to visit 4 (approximately 1 - 2 months)Population: 3 subjects did not complete enough questions on the tool for the total score to be calculated at both time points.
Range 19-76, where higher scores indicate more severe impairment (in terms of 19 common antiepileptic drug side effects.
Outcome measures
| Measure |
Lacosamide
n=37 Participants
Lacosamide: Subjects randomized to lacosamide according to the following schedule:
Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid
|
Sugar Pill
n=7 Participants
Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
|
|---|---|---|
|
Change in Adverse Event Profile (AEP) From Baseline to Visit 4.
|
-1.2 units on a scale
Interval -5.2 to 2.9
|
-6.0 units on a scale
Interval -14.2 to 2.2
|
SECONDARY outcome
Timeframe: Baseline to visit 4 (approximately 1 - 2 months)Population: 5 subjects did not complete enough questions on the tool for the total score to be calculated at both time points.
Range 0-27, where higher scores indicate more impairment (depressive symptoms)
Outcome measures
| Measure |
Lacosamide
n=34 Participants
Lacosamide: Subjects randomized to lacosamide according to the following schedule:
Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid
|
Sugar Pill
n=8 Participants
Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
|
|---|---|---|
|
Change in Patient Health Questionnaire-9 (PHQ-9) From Baseline to Visit 4.
|
-1.1 units on a scale
Interval -2.7 to 0.6
|
-1.2 units on a scale
Interval -4.6 to 2.1
|
SECONDARY outcome
Timeframe: Baseline to visit 4 (approximately 1 - 2 months)Population: 2 subjects did not complete seizure diary at both time points.
Number of seizures per day.
Outcome measures
| Measure |
Lacosamide
n=37 Participants
Lacosamide: Subjects randomized to lacosamide according to the following schedule:
Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid
|
Sugar Pill
n=8 Participants
Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
|
|---|---|---|
|
Change in Daily Seizure Frequency From Baseline to Visit 4
|
0.0 number of seizures per day
Interval 0.0 to 0.15
|
0.0 number of seizures per day
Interval 0.0 to 0.04
|
SECONDARY outcome
Timeframe: Baseline to visit 4 (approximately 1 - 2 months)Population: 5 subjects did not complete enough questions on the tool for the total score to be calculated at both time points.
Range 0 -10 where higher scores reflect better quality of life.
Outcome measures
| Measure |
Lacosamide
n=36 Participants
Lacosamide: Subjects randomized to lacosamide according to the following schedule:
Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid
|
Sugar Pill
n=6 Participants
Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
|
|---|---|---|
|
Change in Quality of Life in Epilepsy (QOLIE-31) From Baseline to Visit 4
|
4.0 units on a scale
Interval 1.2 to 6.7
|
4.2 units on a scale
Interval -2.3 to 10.6
|
Adverse Events
Lacosamide
Serious events: 3 serious events
Other events: 37 other events
Deaths: 0 deaths
Sugar Pill
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lacosamide
n=42 participants at risk
Lacosamide: Subjects randomized to lacosamide according to the following schedule:
Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid
|
Sugar Pill
n=10 participants at risk
Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
|
|---|---|---|
|
Psychiatric disorders
Psychosis
|
2.4%
1/42 • Number of events 1 • Visit 2 - Visit 4, approximately 1 to 2 months.
|
0.00%
0/10 • Visit 2 - Visit 4, approximately 1 to 2 months.
|
|
Nervous system disorders
Increased seizures
|
2.4%
1/42 • Number of events 1 • Visit 2 - Visit 4, approximately 1 to 2 months.
|
0.00%
0/10 • Visit 2 - Visit 4, approximately 1 to 2 months.
|
|
General disorders
Accidental overdose
|
2.4%
1/42 • Number of events 1 • Visit 2 - Visit 4, approximately 1 to 2 months.
|
0.00%
0/10 • Visit 2 - Visit 4, approximately 1 to 2 months.
|
Other adverse events
| Measure |
Lacosamide
n=42 participants at risk
Lacosamide: Subjects randomized to lacosamide according to the following schedule:
Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid
|
Sugar Pill
n=10 participants at risk
Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
|
|---|---|---|
|
Cardiac disorders
Heart palpitations
|
2.4%
1/42 • Visit 2 - Visit 4, approximately 1 to 2 months.
|
20.0%
2/10 • Visit 2 - Visit 4, approximately 1 to 2 months.
|
|
Immune system disorders
Common cold/flu
|
21.4%
9/42 • Visit 2 - Visit 4, approximately 1 to 2 months.
|
10.0%
1/10 • Visit 2 - Visit 4, approximately 1 to 2 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.4%
1/42 • Visit 2 - Visit 4, approximately 1 to 2 months.
|
10.0%
1/10 • Visit 2 - Visit 4, approximately 1 to 2 months.
|
|
Infections and infestations
Infection
|
2.4%
1/42 • Visit 2 - Visit 4, approximately 1 to 2 months.
|
10.0%
1/10 • Visit 2 - Visit 4, approximately 1 to 2 months.
|
|
Injury, poisoning and procedural complications
Skin burn/abrasion/bruise
|
7.1%
3/42 • Visit 2 - Visit 4, approximately 1 to 2 months.
|
0.00%
0/10 • Visit 2 - Visit 4, approximately 1 to 2 months.
|
|
Nervous system disorders
Ataxia
|
9.5%
4/42 • Visit 2 - Visit 4, approximately 1 to 2 months.
|
10.0%
1/10 • Visit 2 - Visit 4, approximately 1 to 2 months.
|
|
Nervous system disorders
Blurred vision
|
19.0%
8/42 • Visit 2 - Visit 4, approximately 1 to 2 months.
|
10.0%
1/10 • Visit 2 - Visit 4, approximately 1 to 2 months.
|
|
Nervous system disorders
Diplopia
|
7.1%
3/42 • Visit 2 - Visit 4, approximately 1 to 2 months.
|
0.00%
0/10 • Visit 2 - Visit 4, approximately 1 to 2 months.
|
|
Nervous system disorders
Shaky hands
|
7.1%
3/42 • Visit 2 - Visit 4, approximately 1 to 2 months.
|
0.00%
0/10 • Visit 2 - Visit 4, approximately 1 to 2 months.
|
|
Injury, poisoning and procedural complications
Fall with injury
|
4.8%
2/42 • Visit 2 - Visit 4, approximately 1 to 2 months.
|
10.0%
1/10 • Visit 2 - Visit 4, approximately 1 to 2 months.
|
|
Nervous system disorders
Dizziness
|
42.9%
18/42 • Visit 2 - Visit 4, approximately 1 to 2 months.
|
30.0%
3/10 • Visit 2 - Visit 4, approximately 1 to 2 months.
|
|
Nervous system disorders
Fatigue
|
9.5%
4/42 • Visit 2 - Visit 4, approximately 1 to 2 months.
|
20.0%
2/10 • Visit 2 - Visit 4, approximately 1 to 2 months.
|
|
Nervous system disorders
Headache
|
40.5%
17/42 • Visit 2 - Visit 4, approximately 1 to 2 months.
|
40.0%
4/10 • Visit 2 - Visit 4, approximately 1 to 2 months.
|
|
Nervous system disorders
Memory impairment
|
4.8%
2/42 • Visit 2 - Visit 4, approximately 1 to 2 months.
|
10.0%
1/10 • Visit 2 - Visit 4, approximately 1 to 2 months.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
7/42 • Visit 2 - Visit 4, approximately 1 to 2 months.
|
20.0%
2/10 • Visit 2 - Visit 4, approximately 1 to 2 months.
|
|
Nervous system disorders
Somnolence
|
7.1%
3/42 • Visit 2 - Visit 4, approximately 1 to 2 months.
|
0.00%
0/10 • Visit 2 - Visit 4, approximately 1 to 2 months.
|
|
Nervous system disorders
Tremor
|
9.5%
4/42 • Visit 2 - Visit 4, approximately 1 to 2 months.
|
0.00%
0/10 • Visit 2 - Visit 4, approximately 1 to 2 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place