Trial Outcomes & Findings for Study to Assess the Long-term Safety of Oral Lacosamide in Subjects With Partial-onset Seizures (NCT NCT00655486)
NCT ID: NCT00655486
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).
COMPLETED
PHASE3
97 participants
2 years
2018-07-17
Participant Flow
The study started in April 2008 with enrollment occuring in the United States only. The study completed June 2010
Participant milestones
| Measure |
Lacosamide
Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years)
|
|---|---|
|
Overall Study
STARTED
|
97
|
|
Overall Study
COMPLETED
|
69
|
|
Overall Study
NOT COMPLETED
|
28
|
Reasons for withdrawal
| Measure |
Lacosamide
Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years)
|
|---|---|
|
Overall Study
Adverse Event
|
10
|
|
Overall Study
Lack of Efficacy
|
8
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Unsatisfactory compliance
|
2
|
|
Overall Study
Other: Pregnancy
|
1
|
|
Overall Study
Other: Could not tolerate BID dosing
|
1
|
|
Overall Study
Other: Abnormal electrocardiogram (ECG)
|
1
|
Baseline Characteristics
Study to Assess the Long-term Safety of Oral Lacosamide in Subjects With Partial-onset Seizures
Baseline characteristics by cohort
| Measure |
Lacosamide
n=97 Participants
Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years)
|
|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
95 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Age, Continuous
|
38.8 years
STANDARD_DEVIATION 11.71 • n=93 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
97 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: All 97 subjects enrolled are in the Safety Set (SS) and are included in this analysis
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
n=97 Participants
Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years)
|
|---|---|
|
Number of Subjects With at Least One Adverse Event During This Open-label Extension Study (Maximum Study Duration 2 Years)
|
93 subjects
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: All 97 subjects enrolled are in the Safety Set (SS) and are included in this analysis
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
n=97 Participants
Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years)
|
|---|---|
|
Number of Subjects Who Withdrew From the Study Due to an Adverse Event (Maximum Study Duration 2 Years)
|
10 subjects
|
Adverse Events
Lacosamide
Serious adverse events
| Measure |
Lacosamide
n=97 participants at risk
Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years)
|
|---|---|
|
Cardiac disorders
Arrhythmia supraventricular
|
1.0%
1/97 • Number of events 1 • 2 years
|
|
Cardiac disorders
Atrial fibrillation
|
1.0%
1/97 • Number of events 1 • 2 years
|
|
General disorders
Chest pain
|
1.0%
1/97 • Number of events 1 • 2 years
|
|
General disorders
Drug interaction
|
1.0%
1/97 • Number of events 1 • 2 years
|
|
Infections and infestations
Giardiasis
|
1.0%
1/97 • Number of events 1 • 2 years
|
|
Infections and infestations
Pneumonia
|
1.0%
1/97 • Number of events 1 • 2 years
|
|
Infections and infestations
Sepsis
|
1.0%
1/97 • Number of events 1 • 2 years
|
|
Injury, poisoning and procedural complications
Post procedural bile leak
|
1.0%
1/97 • Number of events 1 • 2 years
|
|
Nervous system disorders
Convulsion
|
2.1%
2/97 • Number of events 2 • 2 years
|
|
Nervous system disorders
Lethargy
|
1.0%
1/97 • Number of events 1 • 2 years
|
|
Psychiatric disorders
Hallucination
|
1.0%
1/97 • Number of events 1 • 2 years
|
|
Psychiatric disorders
Homicidal ideation
|
1.0%
1/97 • Number of events 1 • 2 years
|
|
Psychiatric disorders
Paranoia
|
1.0%
1/97 • Number of events 1 • 2 years
|
|
Psychiatric disorders
Depression suicidal
|
1.0%
1/97 • Number of events 1 • 2 years
|
Other adverse events
| Measure |
Lacosamide
n=97 participants at risk
Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years)
|
|---|---|
|
Ear and labyrinth disorders
Tinnitus
|
5.2%
5/97 • Number of events 5 • 2 years
|
|
Eye disorders
Diplopia
|
17.5%
17/97 • Number of events 18 • 2 years
|
|
Eye disorders
Vision blurred
|
10.3%
10/97 • Number of events 10 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
16.5%
16/97 • Number of events 18 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
13.4%
13/97 • Number of events 14 • 2 years
|
|
Gastrointestinal disorders
Diarrhoea
|
12.4%
12/97 • Number of events 13 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
5.2%
5/97 • Number of events 6 • 2 years
|
|
General disorders
Fatigue
|
12.4%
12/97 • Number of events 12 • 2 years
|
|
General disorders
Chest pain
|
8.2%
8/97 • Number of events 9 • 2 years
|
|
General disorders
Irritability
|
5.2%
5/97 • Number of events 6 • 2 years
|
|
Infections and infestations
Upper respiratory tract infection
|
14.4%
14/97 • Number of events 17 • 2 years
|
|
Infections and infestations
Sinusitis
|
8.2%
8/97 • Number of events 11 • 2 years
|
|
Infections and infestations
Urinary tract infection
|
7.2%
7/97 • Number of events 8 • 2 years
|
|
Infections and infestations
Nasopharyngitis
|
6.2%
6/97 • Number of events 7 • 2 years
|
|
Injury, poisoning and procedural complications
Contusion
|
5.2%
5/97 • Number of events 5 • 2 years
|
|
Investigations
Weight increased
|
6.2%
6/97 • Number of events 6 • 2 years
|
|
Nervous system disorders
Dizziness
|
44.3%
43/97 • Number of events 50 • 2 years
|
|
Nervous system disorders
Somnolence
|
12.4%
12/97 • Number of events 13 • 2 years
|
|
Nervous system disorders
Coordination abnormal
|
11.3%
11/97 • Number of events 13 • 2 years
|
|
Nervous system disorders
Headache
|
11.3%
11/97 • Number of events 11 • 2 years
|
|
Nervous system disorders
Balance disorder
|
11.3%
11/97 • Number of events 13 • 2 years
|
|
Nervous system disorders
Tremor
|
8.2%
8/97 • Number of events 10 • 2 years
|
|
Nervous system disorders
Memory impairment
|
5.2%
5/97 • Number of events 5 • 2 years
|
|
Nervous system disorders
Hypoaesthesia
|
5.2%
5/97 • Number of events 7 • 2 years
|
|
Psychiatric disorders
Insomnia
|
9.3%
9/97 • Number of events 9 • 2 years
|
|
Psychiatric disorders
Confusional state
|
8.2%
8/97 • Number of events 8 • 2 years
|
|
Psychiatric disorders
Depression
|
7.2%
7/97 • Number of events 7 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.2%
5/97 • Number of events 5 • 2 years
|
Additional Information
UCB Clinical Trial Call Center
UCB, Inc
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