Trial Outcomes & Findings for Safety of Intravenous Lacosamide Dose Followed by Twice Daily Oral Lacosamide in Subjects With Partial-onset Seizures (NCT NCT00655551)
NCT ID: NCT00655551
Last Updated: 2018-07-17
Results Overview
An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
100 participants
Primary outcome timeframe
Treatment period (up to 7 days)
Results posted on
2018-07-17
Participant Flow
Participant milestones
| Measure |
Lacosamide (200 mg)
Single loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily
|
Lacosamide (300 mg)
Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily
|
Lacosamide (400 mg)
Single loading dose of intravenous (iv) lacosamide 400 mg followed by 6.5 days of oral lacosamide 200 mg twice daily
|
|---|---|---|---|
|
All Periods Combined
STARTED
|
25
|
50
|
25
|
|
All Periods Combined
COMPLETED
|
25
|
47
|
21
|
|
All Periods Combined
NOT COMPLETED
|
0
|
3
|
4
|
|
Period 1 (up to 7 Days)
STARTED
|
25
|
0
|
0
|
|
Period 1 (up to 7 Days)
COMPLETED
|
25
|
0
|
0
|
|
Period 1 (up to 7 Days)
NOT COMPLETED
|
0
|
0
|
0
|
|
Period 2 (up to 7 Days)
STARTED
|
0
|
25
|
0
|
|
Period 2 (up to 7 Days)
COMPLETED
|
0
|
24
|
0
|
|
Period 2 (up to 7 Days)
NOT COMPLETED
|
0
|
1
|
0
|
|
Period 3 (up to 7 Days)
STARTED
|
0
|
0
|
25
|
|
Period 3 (up to 7 Days)
COMPLETED
|
0
|
0
|
21
|
|
Period 3 (up to 7 Days)
NOT COMPLETED
|
0
|
0
|
4
|
|
Period 4 (up to 7 Days)
STARTED
|
0
|
25
|
0
|
|
Period 4 (up to 7 Days)
COMPLETED
|
0
|
23
|
0
|
|
Period 4 (up to 7 Days)
NOT COMPLETED
|
0
|
2
|
0
|
Reasons for withdrawal
| Measure |
Lacosamide (200 mg)
Single loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily
|
Lacosamide (300 mg)
Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily
|
Lacosamide (400 mg)
Single loading dose of intravenous (iv) lacosamide 400 mg followed by 6.5 days of oral lacosamide 200 mg twice daily
|
|---|---|---|---|
|
All Periods Combined
Adverse Event
|
0
|
3
|
4
|
|
Period 2 (up to 7 Days)
Adverse Event
|
0
|
1
|
0
|
|
Period 3 (up to 7 Days)
Adverse Event
|
0
|
0
|
4
|
|
Period 4 (up to 7 Days)
Adverse Event
|
0
|
2
|
0
|
Baseline Characteristics
Safety of Intravenous Lacosamide Dose Followed by Twice Daily Oral Lacosamide in Subjects With Partial-onset Seizures
Baseline characteristics by cohort
| Measure |
Lacosamide (200 mg)
n=25 Participants
Single loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily
|
Lacosamide (300 mg)
n=50 Participants
Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily
|
Lacosamide (400 mg)
n=25 Participants
Single loading dose of intravenous (iv) lacosamide 400 mg followed by 6.5 days of oral lacosamide 200 mg twice daily
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
98 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
39.1 years
STANDARD_DEVIATION 11.77 • n=5 Participants
|
38.6 years
STANDARD_DEVIATION 11.53 • n=7 Participants
|
39.6 years
STANDARD_DEVIATION 12.24 • n=5 Participants
|
39.0 years
STANDARD_DEVIATION 11.66 • n=4 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
50 participants
n=7 Participants
|
25 participants
n=5 Participants
|
100 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Treatment period (up to 7 days)An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).
Outcome measures
| Measure |
Lacosamide (200 mg)
n=25 Participants
Single loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily
|
Lacosamide (300 mg)
n=50 Participants
Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily
|
Lacosamide (400 mg)
n=25 Participants
Single loading dose of intravenous (iv) lacosamide 400 mg followed by 6.5 days of oral lacosamide 200 mg twice daily
|
|---|---|---|---|
|
Number of Subjects With at Least One Adverse Event During the Treatment Period (up to 7 Days)
|
17 subjects
|
42 subjects
|
20 subjects
|
PRIMARY outcome
Timeframe: Entire trial period (up to 6 weeks), screening through safety follow-up period (2 weeks post last medication)An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).
Outcome measures
| Measure |
Lacosamide (200 mg)
n=25 Participants
Single loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily
|
Lacosamide (300 mg)
n=50 Participants
Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily
|
Lacosamide (400 mg)
n=25 Participants
Single loading dose of intravenous (iv) lacosamide 400 mg followed by 6.5 days of oral lacosamide 200 mg twice daily
|
|---|---|---|---|
|
Number of Subjects Who Withdrew From the Trial Due to an Adverse Event
|
0 subjects
|
3 subjects
|
4 subjects
|
SECONDARY outcome
Timeframe: 0-4 hours post start of the infusionAn Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).
Outcome measures
| Measure |
Lacosamide (200 mg)
n=25 Participants
Single loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily
|
Lacosamide (300 mg)
n=50 Participants
Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily
|
Lacosamide (400 mg)
n=25 Participants
Single loading dose of intravenous (iv) lacosamide 400 mg followed by 6.5 days of oral lacosamide 200 mg twice daily
|
|---|---|---|---|
|
Number of Subjects With at Least One Adverse Event With an Onset Within 4 Hours of Start of Infusion
|
5 subjects
|
24 subjects
|
16 subjects
|
Adverse Events
Lacosamide (200 mg)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Lacosamide (300 mg)
Serious events: 0 serious events
Other events: 37 other events
Deaths: 0 deaths
Lacosamide (400 mg)
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lacosamide (200 mg)
n=25 participants at risk
Single loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily
|
Lacosamide (300 mg)
n=50 participants at risk
Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily
|
Lacosamide (400 mg)
n=25 participants at risk
Single loading dose of intravenous (iv) lacosamide 400 mg followed by 6.5 days of oral lacosamide 200 mg twice daily
|
|---|---|---|---|
|
General disorders
Chest pain
|
0.00%
0/25 • up to 7 days
|
0.00%
0/50 • up to 7 days
|
4.0%
1/25 • Number of events 1 • up to 7 days
|
Other adverse events
| Measure |
Lacosamide (200 mg)
n=25 participants at risk
Single loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily
|
Lacosamide (300 mg)
n=50 participants at risk
Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily
|
Lacosamide (400 mg)
n=25 participants at risk
Single loading dose of intravenous (iv) lacosamide 400 mg followed by 6.5 days of oral lacosamide 200 mg twice daily
|
|---|---|---|---|
|
Eye disorders
Diplopia
|
4.0%
1/25 • Number of events 1 • up to 7 days
|
6.0%
3/50 • Number of events 3 • up to 7 days
|
20.0%
5/25 • Number of events 6 • up to 7 days
|
|
Eye disorders
Vision blurred
|
0.00%
0/25 • up to 7 days
|
4.0%
2/50 • Number of events 2 • up to 7 days
|
12.0%
3/25 • Number of events 3 • up to 7 days
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/25 • up to 7 days
|
16.0%
8/50 • Number of events 8 • up to 7 days
|
24.0%
6/25 • Number of events 8 • up to 7 days
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/25 • up to 7 days
|
6.0%
3/50 • Number of events 3 • up to 7 days
|
12.0%
3/25 • Number of events 3 • up to 7 days
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/25 • up to 7 days
|
6.0%
3/50 • Number of events 5 • up to 7 days
|
8.0%
2/25 • Number of events 2 • up to 7 days
|
|
Gastrointestinal disorders
Paraesthesia oral
|
4.0%
1/25 • Number of events 1 • up to 7 days
|
4.0%
2/50 • Number of events 2 • up to 7 days
|
8.0%
2/25 • Number of events 2 • up to 7 days
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/25 • up to 7 days
|
4.0%
2/50 • Number of events 2 • up to 7 days
|
12.0%
3/25 • Number of events 3 • up to 7 days
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/25 • up to 7 days
|
8.0%
4/50 • Number of events 4 • up to 7 days
|
0.00%
0/25 • up to 7 days
|
|
General disorders
Fatigue
|
0.00%
0/25 • up to 7 days
|
18.0%
9/50 • Number of events 9 • up to 7 days
|
12.0%
3/25 • Number of events 3 • up to 7 days
|
|
General disorders
Gait disturbance
|
8.0%
2/25 • Number of events 2 • up to 7 days
|
2.0%
1/50 • Number of events 1 • up to 7 days
|
0.00%
0/25 • up to 7 days
|
|
Nervous system disorders
Dizziness
|
20.0%
5/25 • Number of events 6 • up to 7 days
|
46.0%
23/50 • Number of events 27 • up to 7 days
|
60.0%
15/25 • Number of events 19 • up to 7 days
|
|
Nervous system disorders
Somnolence
|
0.00%
0/25 • up to 7 days
|
34.0%
17/50 • Number of events 18 • up to 7 days
|
36.0%
9/25 • Number of events 9 • up to 7 days
|
|
Nervous system disorders
Headache
|
8.0%
2/25 • Number of events 2 • up to 7 days
|
4.0%
2/50 • Number of events 2 • up to 7 days
|
16.0%
4/25 • Number of events 4 • up to 7 days
|
|
Nervous system disorders
Paraesthesia
|
8.0%
2/25 • Number of events 2 • up to 7 days
|
6.0%
3/50 • Number of events 3 • up to 7 days
|
4.0%
1/25 • Number of events 4 • up to 7 days
|
|
Nervous system disorders
Tremor
|
0.00%
0/25 • up to 7 days
|
6.0%
3/50 • Number of events 3 • up to 7 days
|
4.0%
1/25 • Number of events 1 • up to 7 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/25 • up to 7 days
|
6.0%
3/50 • Number of events 3 • up to 7 days
|
4.0%
1/25 • Number of events 1 • up to 7 days
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/25 • up to 7 days
|
0.00%
0/50 • up to 7 days
|
8.0%
2/25 • Number of events 2 • up to 7 days
|
|
General disorders
Chest pain
|
0.00%
0/25 • up to 7 days
|
0.00%
0/50 • up to 7 days
|
8.0%
2/25 • Number of events 2 • up to 7 days
|
|
Nervous system disorders
Coordination abnormal
|
0.00%
0/25 • up to 7 days
|
6.0%
3/50 • Number of events 3 • up to 7 days
|
0.00%
0/25 • up to 7 days
|
Additional Information
UCB Clinical Trial Call Center
UCB, Inc
Phone: +1 877 822 9493
Results disclosure agreements
- Principal investigator is a sponsor employee UCB has \> 60 days but \<= 180 days to review results communications prior to public release and may delete information that is confidential and compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
- Publication restrictions are in place
Restriction type: OTHER