Trial Outcomes & Findings for Study on the Treatment of Elderly Patients With Older and Newer Antiepileptic Drugs (NCT NCT00438451)
NCT ID: NCT00438451
Last Updated: 2013-02-28
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
361 participants
Primary outcome timeframe
58 weeks
Results posted on
2013-02-28
Participant Flow
43 study centres in three countries participated in this study (31 in Germany, 5 in Austria, 7 in Switzerland). The number of patients recruited in each country (242 Germany, 55 Austria, 29 Switzerland) and per centre (range from 1 to 53) was heterogeneous. Therefore, centre effects were explored by pooling the centres with less than 20 subjects.
In total, 361 patients were randomized. 359 patients were analysed ITT (patient 0213 did not suffer from epilepsy, patient 3604 should not have been asked for informed consent, because of his legal guardianship).
Participant milestones
| Measure |
Levetiracetam
Levetiracetam 250mg: capsules, each containing one Levetiracetam 250mg film-coated tablet.
During titration phase, subjects received 1 capsule in the evening in the first 14 days, 2 capsules (1 in the morning and 1 in the evening) in week 3 and 4, 3 capsules in week 5 (1 in the morning and 2 in the evening) and 4 capsules from week 6 onwards (2 in the morning and 2 in the evening). During maintenance phase, dose adjustments could be made according to tolerability and seizure control in steps of 1 capsule per week. Dosages between 2 to 12 capsules per day were allowed.
|
Carbamazepine
Carbamazepine 100mg: capsules, each containing half of one Carbamazepine 200mg slow release tablet.
During titration phase, subjects received 1 capsule in the evening in the first 14 days, 2 capsules (1 in the morning and 1 in the evening) in week 3 and 4, 3 capsules in week 5 (1 in the morning and 2 in the evening) and 4 capsules from week 6 onwards (2 in the morning and 2 in the evening). During maintenance phase, dose adjustments could be made according to tolerability and seizure control in steps of 1 capsule per week. Dosages between 2 to 12 capsules per day were allowed.
|
Lamotrigine
Lamotrigine 25mg: capsules, each containing one Lamotrigine 25mg tablet. During titration phase, subjects received 1 capsule in the evening in the first 14 days, 2 capsules (1 in the morning and 1 in the evening) in week 3 and 4, 3 capsules in week 5 (1 in the morning and 2 in the evening) and 4 capsules from week 6 onwards (2 in the morning and 2 in the evening). During maintenance phase, dose adjustments could be made according to tolerability and seizure control in steps of 1 capsule per week. Dosages between 2 to 12 capsules per day were allowed.
|
|---|---|---|---|
|
Overall Study
STARTED
|
122
|
121
|
118
|
|
Overall Study
Safety Population
|
122
|
121
|
117
|
|
Overall Study
ITT Population
|
122
|
120
|
117
|
|
Overall Study
Maintenance Phase (Week 7-58)
|
93
|
89
|
93
|
|
Overall Study
COMPLETED
|
75
|
55
|
65
|
|
Overall Study
NOT COMPLETED
|
47
|
66
|
53
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study on the Treatment of Elderly Patients With Older and Newer Antiepileptic Drugs
Baseline characteristics by cohort
| Measure |
Levetiracetam
n=122 Participants
Levetiracetam 250mg
|
Carbamazepine
n=120 Participants
Carbamazepine 100mg
|
Lamotrigine
n=117 Participants
Lamotrigine 25mg
|
Total
n=359 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
71.8 years
STANDARD_DEVIATION 7.49 • n=5 Participants
|
71.7 years
STANDARD_DEVIATION 6.66 • n=7 Participants
|
70.7 years
STANDARD_DEVIATION 7.43 • n=5 Participants
|
71.4 years
STANDARD_DEVIATION 7.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
144 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
81 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
215 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
122 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
359 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
95 participants
n=5 Participants
|
92 participants
n=7 Participants
|
91 participants
n=5 Participants
|
278 participants
n=4 Participants
|
|
Region of Enrollment
Austria
|
18 participants
n=5 Participants
|
18 participants
n=7 Participants
|
16 participants
n=5 Participants
|
52 participants
n=4 Participants
|
|
Region of Enrollment
Switzerland
|
9 participants
n=5 Participants
|
10 participants
n=7 Participants
|
10 participants
n=5 Participants
|
29 participants
n=4 Participants
|
|
Epilepsy history - number of seizures
|
3.8 number of seizures
STANDARD_DEVIATION 9.85 • n=5 Participants
|
4.8 number of seizures
STANDARD_DEVIATION 10.78 • n=7 Participants
|
2.7 number of seizures
STANDARD_DEVIATION 3.14 • n=5 Participants
|
3.75 number of seizures
STANDARD_DEVIATION 8.69 • n=4 Participants
|
|
Epilepsy history - Aura
Yes
|
23 participants
n=5 Participants
|
28 participants
n=7 Participants
|
21 participants
n=5 Participants
|
72 participants
n=4 Participants
|
|
Epilepsy history - Aura
No
|
99 participants
n=5 Participants
|
92 participants
n=7 Participants
|
95 participants
n=5 Participants
|
286 participants
n=4 Participants
|
|
Epilepsy history - Aura
NA
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Epilepsy history - Autonomic seizure
Yes
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Epilepsy history - Autonomic seizure
No
|
121 participants
n=5 Participants
|
118 participants
n=7 Participants
|
117 participants
n=5 Participants
|
356 participants
n=4 Participants
|
|
Epilepsy history - Dialeptic seizure
Yes
|
13 participants
n=5 Participants
|
15 participants
n=7 Participants
|
18 participants
n=5 Participants
|
46 participants
n=4 Participants
|
|
Epilepsy history - Dialeptic seizure
No
|
109 participants
n=5 Participants
|
105 participants
n=7 Participants
|
99 participants
n=5 Participants
|
313 participants
n=4 Participants
|
|
Epilepsy history - Motor seizure
Yes
|
95 participants
n=5 Participants
|
101 participants
n=7 Participants
|
95 participants
n=5 Participants
|
291 participants
n=4 Participants
|
|
Epilepsy history - Motor seizure
No
|
27 participants
n=5 Participants
|
19 participants
n=7 Participants
|
22 participants
n=5 Participants
|
68 participants
n=4 Participants
|
|
Epileptic history - Special seizure
Yes
|
8 participants
n=5 Participants
|
13 participants
n=7 Participants
|
12 participants
n=5 Participants
|
33 participants
n=4 Participants
|
|
Epileptic history - Special seizure
No
|
114 participants
n=5 Participants
|
107 participants
n=7 Participants
|
105 participants
n=5 Participants
|
326 participants
n=4 Participants
|
|
EEG (electroencephalogram) pathological
Yes
|
86 participants
n=5 Participants
|
84 participants
n=7 Participants
|
71 participants
n=5 Participants
|
241 participants
n=4 Participants
|
|
EEG (electroencephalogram) pathological
No
|
35 participants
n=5 Participants
|
36 participants
n=7 Participants
|
45 participants
n=5 Participants
|
116 participants
n=4 Participants
|
|
EEG (electroencephalogram) pathological
Missing
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
MRT (Magnetic Resonance Tomograhy) pathological
Yes
|
59 participants
n=5 Participants
|
63 participants
n=7 Participants
|
62 participants
n=5 Participants
|
184 participants
n=4 Participants
|
|
MRT (Magnetic Resonance Tomograhy) pathological
No
|
11 participants
n=5 Participants
|
10 participants
n=7 Participants
|
13 participants
n=5 Participants
|
34 participants
n=4 Participants
|
|
MRT (Magnetic Resonance Tomograhy) pathological
Missing
|
52 participants
n=5 Participants
|
47 participants
n=7 Participants
|
42 participants
n=5 Participants
|
141 participants
n=4 Participants
|
|
CCT (Cranial Computed Tomography) pathological
Yes
|
76 participants
n=5 Participants
|
82 participants
n=7 Participants
|
64 participants
n=5 Participants
|
222 participants
n=4 Participants
|
|
CCT (Cranial Computed Tomography) pathological
No
|
23 participants
n=5 Participants
|
19 participants
n=7 Participants
|
19 participants
n=5 Participants
|
61 participants
n=4 Participants
|
|
CCT (Cranial Computed Tomography) pathological
Missing
|
23 participants
n=5 Participants
|
19 participants
n=7 Participants
|
34 participants
n=5 Participants
|
76 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 58 weeksPopulation: ITT population: All randomized patients were included in the Intention-to-Treat (ITT) population except patients that were not evaluable for efficacy e.g. patients without epilepsy or patients not able to comply with the study requirements.
Outcome measures
| Measure |
Levetiracetam
n=122 Participants
Levetiracetam 250mg
|
Carbamazepine
n=120 Participants
Carbamazepine 100mg
|
Lamotrigine
n=117 Participants
Lamotrigine 25mg
|
|---|---|---|---|
|
58-week Retention Rate Measured by the Number of Drop Outs Due to Adverse Events or Seizures From Day 1 of Treatment
|
0.61 proportion of participants
Interval 0.53 to 0.7
|
0.46 proportion of participants
Interval 0.37 to 0.55
|
0.56 proportion of participants
Interval 0.47 to 0.65
|
SECONDARY outcome
Timeframe: 58 weeksPopulation: ITT population: All randomized patients were included in the Intention-to-Treat (ITT) population except patients that were not evaluable for efficacy e.g. patients without epilepsy or patients not able to comply with the study requirements.
number of days between randomization and premature discontinuation of the study
Outcome measures
| Measure |
Levetiracetam
n=122 Participants
Levetiracetam 250mg
|
Carbamazepine
n=120 Participants
Carbamazepine 100mg
|
Lamotrigine
n=117 Participants
Lamotrigine 25mg
|
|---|---|---|---|
|
Time to Drop Out
|
NA days
less than 50% of patients dropped out
|
265 days
Interval 119.0 to
not enough patients dropped out
|
NA days
Interval 270.0 to
less than 50% of patients dropped out
|
SECONDARY outcome
Timeframe: Week 30Population: ITT population: All randomized patients were included in the Intention-to-Treat (ITT) population except patients that were not evaluable for efficacy e.g. patients without epilepsy or patients not able to comply with the study requirements.
Percentage of patients experiencing no seizures until week 30 (Visit 4) and did not discontinue the study until week 30.
Outcome measures
| Measure |
Levetiracetam
n=122 Participants
Levetiracetam 250mg
|
Carbamazepine
n=120 Participants
Carbamazepine 100mg
|
Lamotrigine
n=117 Participants
Lamotrigine 25mg
|
|---|---|---|---|
|
Percentage of Patients Remaining Seizure-free at Week 30 (Visit 4)
|
48 percentage of participants
|
39 percentage of participants
|
49 percentage of participants
|
SECONDARY outcome
Timeframe: week 58Population: ITT population: All randomized patients were included in the Intention-to-Treat (ITT) population except patients that were not evaluable for efficacy e.g. patients without epilepsy or patients not able to comply with the study requirements.
Percentage of patients experiencing no seizures until week 58 (Visit 6) and did not discontinue the study until week 58.
Outcome measures
| Measure |
Levetiracetam
n=122 Participants
Levetiracetam 250mg
|
Carbamazepine
n=120 Participants
Carbamazepine 100mg
|
Lamotrigine
n=117 Participants
Lamotrigine 25mg
|
|---|---|---|---|
|
Percentage of Patients Remaining Seizure Free at Week 58 (Visit 6)
|
43 percentage of participants
|
33 percentage of participants
|
38 percentage of participants
|
SECONDARY outcome
Timeframe: over the whole duration of 58 weeksPopulation: ITT population: All randomized patients were included in the Intention-to-Treat (ITT) population except patients that were not evaluable for efficacy e.g. patients without epilepsy or patients not able to comply with the study requirements.
Outcome measures
| Measure |
Levetiracetam
n=122 Participants
Levetiracetam 250mg
|
Carbamazepine
n=120 Participants
Carbamazepine 100mg
|
Lamotrigine
n=117 Participants
Lamotrigine 25mg
|
|---|---|---|---|
|
The Time (in Days) to First Break-through Seizure (From Day 1 of Treatment)
|
NA days
could not be estimated since there were less than 50% events
|
NA days
could not be estimated since there were less than 50% events
|
NA days
Interval 308.0 to
could not be estimated since there were less than 50% events
|
SECONDARY outcome
Timeframe: over 52 weeksPopulation: Completer population: The completer population comprises all patients still being in the study at week 58 (This definition deviates minimally from the protocol. It could not be assessed from the CRF data, if patients were on treatment).
Seizure frequency was assessed by investigators in the CRF at the Visits V3, V4, V5 and V6. The absolute seizure frequency during the maintenance phase was defined as the sum of those entries.
Outcome measures
| Measure |
Levetiracetam
n=75 Participants
Levetiracetam 250mg
|
Carbamazepine
n=55 Participants
Carbamazepine 100mg
|
Lamotrigine
n=65 Participants
Lamotrigine 25mg
|
|---|---|---|---|
|
The Absolute Seizure Frequency During the Maintenance Phase (Weeks 7 - 58)
|
168 number of seizures
|
131 number of seizures
|
130 number of seizures
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Patients of ITT population who reached the maintenance phase
Outcome measures
| Measure |
Levetiracetam
n=91 Participants
Levetiracetam 250mg
|
Carbamazepine
n=87 Participants
Carbamazepine 100mg
|
Lamotrigine
n=91 Participants
Lamotrigine 25mg
|
|---|---|---|---|
|
Proportion of Seizure-free Days During the Maintenance Phase for Subjects Who Enter the Maintenance Phase
|
0.99 proportion of seizure-free days
|
0.99 proportion of seizure-free days
|
0.99 proportion of seizure-free days
|
SECONDARY outcome
Timeframe: 58 weeks, final visitPopulation: Patients of ITT population who filled out QOLIE-31 at V6
The QOLIE-31 is a 31 item score that measures the quality of life in epilepsy (each item with a range of 0 to 100). There are 7 sub-scores seizure worry (items 11,21,22,23,25), overall quality of life (items 1,14), emotional well-being (items 3,4,5,7,9), energy/fatigue (items 2,6,8,10), cognitive functioning (items 12,15,16,17,18,26), medication effects (items 24,29,30) and social functioning (13,19,20,27,28). These scores were combined to a total score by Total score = seizure worry\*0.08 + overall quality of life\*0.14 + emotional well-being\*0.15 + energy/fatigue\*0.12 + cognitive functioning\*0.27 + medication effects\*0.03 + social functioning\*0.21 For all scores, higher values indicate better quality of life. Each score has a possible range from 0 to 100.
Outcome measures
| Measure |
Levetiracetam
n=90 Participants
Levetiracetam 250mg
|
Carbamazepine
n=90 Participants
Carbamazepine 100mg
|
Lamotrigine
n=89 Participants
Lamotrigine 25mg
|
|---|---|---|---|
|
QOLIE-31 (Quality Of Life In Epilepsy) Results at V6
Seizure worry
|
85.1 units on a scale
Standard Deviation 19.89 • Interval 25.0 to 100.0
|
75.4 units on a scale
Standard Deviation 26.87 • Interval 0.0 to 100.0
|
75.0 units on a scale
Standard Deviation 26.26 • Interval 0.0 to 100.0
|
|
QOLIE-31 (Quality Of Life In Epilepsy) Results at V6
Overall quality of life
|
67.2 units on a scale
Standard Deviation 21.76 • Interval 10.0 to 100.0
|
65.0 units on a scale
Standard Deviation 20.65 • Interval 5.0 to 100.0
|
67.1 units on a scale
Standard Deviation 20.96 • Interval 10.0 to 100.0
|
|
QOLIE-31 (Quality Of Life In Epilepsy) Results at V6
Emotional well-being
|
72.0 units on a scale
Standard Deviation 19.42 • Interval 16.0 to 100.0
|
69.8 units on a scale
Standard Deviation 18.76 • Interval 20.0 to 100.0
|
67.4 units on a scale
Standard Deviation 20.25 • Interval 16.0 to 100.0
|
|
QOLIE-31 (Quality Of Life In Epilepsy) Results at V6
Energy/fatigue
|
60.8 units on a scale
Standard Deviation 21.03 • Interval 15.0 to 100.0
|
54.5 units on a scale
Standard Deviation 21.33 • Interval 5.0 to 95.0
|
59.8 units on a scale
Standard Deviation 22.07 • Interval 10.0 to 100.0
|
|
QOLIE-31 (Quality Of Life In Epilepsy) Results at V6
Cognitive functioning
|
75.1 units on a scale
Standard Deviation 19.48 • Interval 10.0 to 100.0
|
68.9 units on a scale
Standard Deviation 20.96 • Interval 18.0 to 100.0
|
68.0 units on a scale
Standard Deviation 21.11 • Interval 10.0 to 100.0
|
|
QOLIE-31 (Quality Of Life In Epilepsy) Results at V6
Medication effects
|
77.6 units on a scale
Standard Deviation 26.78 • Interval 0.0 to 100.0
|
70.6 units on a scale
Standard Deviation 28.21 • Interval 0.0 to 100.0
|
72.6 units on a scale
Standard Deviation 30.34 • Interval 0.0 to 100.0
|
|
QOLIE-31 (Quality Of Life In Epilepsy) Results at V6
Social functioning
|
81.1 units on a scale
Standard Deviation 19.23 • Interval 25.0 to 100.0
|
76.3 units on a scale
Standard Deviation 25.49 • Interval 5.0 to 100.0
|
76.7 units on a scale
Standard Deviation 24.28 • Interval 5.0 to 100.0
|
|
QOLIE-31 (Quality Of Life In Epilepsy) Results at V6
Total Score
|
73.9 units on a scale
Standard Deviation 15.89 • Interval 26.0 to 100.0
|
68.9 units on a scale
Standard Deviation 17.80 • Interval 30.0 to 96.0
|
69.1 units on a scale
Standard Deviation 17.12 • Interval 17.0 to 96.0
|
|
QOLIE-31 (Quality Of Life In Epilepsy) Results at V6
Health Scale
|
69.5 units on a scale
Standard Deviation 19.28 • Interval 20.0 to 100.0
|
65.7 units on a scale
Standard Deviation 21.21 • Interval 10.0 to 100.0
|
67.5 units on a scale
Standard Deviation 19.84 • Interval 20.0 to 100.0
|
SECONDARY outcome
Timeframe: at week 58Population: Patients of ITT population who filled out PNS at V6
The PNS is a 15-item scale. Each item can be scored from 1 to 9. There are a total score (includes all items, range:15 to 135) and two subscores: The cognitive toxicity subscore (10 items: Energy Level, Memory, Interest, Concentration, Forgetfulness, Sleepliness, Moodiness, Alertness, Attention Span, Motivation, range:10 to 90) and the somatomoto subscore (5 items: Vision, Walking, Coordination, Tremor, Speech, range:5-45). The score is calculated by taking the mean of all non-missing values times the number of items. Lower values indicate better quality of life.
Outcome measures
| Measure |
Levetiracetam
n=90 Participants
Levetiracetam 250mg
|
Carbamazepine
n=90 Participants
Carbamazepine 100mg
|
Lamotrigine
n=89 Participants
Lamotrigine 25mg
|
|---|---|---|---|
|
Portland Neurotoxicity Scale (PNS) at V6
Cognitive toxicity subscore
|
22.2 units on a scale
Standard Deviation 12.52 • Interval 10.0 to 79.0
|
27.3 units on a scale
Standard Deviation 15.71 • Interval 10.0 to 82.0
|
23.7 units on a scale
Standard Deviation 11.44 • Interval 10.0 to 66.0
|
|
Portland Neurotoxicity Scale (PNS) at V6
Somatomotor subscore
|
10.5 units on a scale
Standard Deviation 5.53 • Interval 5.0 to 28.0
|
11.4 units on a scale
Standard Deviation 6.96 • Interval 5.0 to 35.0
|
10.8 units on a scale
Standard Deviation 5.42 • Interval 5.0 to 31.0
|
|
Portland Neurotoxicity Scale (PNS) at V6
Total Score
|
32.7 units on a scale
Standard Deviation 16.81 • Interval 15.0 to 107.0
|
38.7 units on a scale
Standard Deviation 21.73 • Interval 15.0 to 110.0
|
34.5 units on a scale
Standard Deviation 15.67 • Interval 15.0 to 83.0
|
SECONDARY outcome
Timeframe: week 58Population: Patients of ITT population who had data at V6
EPITrack-Score shows the performance of attention and executive functions. Higher values indicate a better performance. The results of EPITrack Score ranges between 7 and 45.
Outcome measures
| Measure |
Levetiracetam
n=84 Participants
Levetiracetam 250mg
|
Carbamazepine
n=84 Participants
Carbamazepine 100mg
|
Lamotrigine
n=85 Participants
Lamotrigine 25mg
|
|---|---|---|---|
|
Results of Cognitive Testing (EpiTrack© by UCB) - Score at V6
|
26.0 units on a scale
Standard Deviation 7.22 • Interval 11.0 to 38.0
|
26.0 units on a scale
Standard Deviation 7.05 • Interval 8.0 to 39.0
|
25.4 units on a scale
Standard Deviation 6.82 • Interval 7.0 to 39.0
|
SECONDARY outcome
Timeframe: 58 weeksPopulation: Patients of ITT population with data at V6
Evaluation of current testing at V6: ≥29 score points: Inconspicuous; 26 to 28 score points: Borderline; ≤25 score points: Impaired
Outcome measures
| Measure |
Levetiracetam
n=84 Participants
Levetiracetam 250mg
|
Carbamazepine
n=84 Participants
Carbamazepine 100mg
|
Lamotrigine
n=85 Participants
Lamotrigine 25mg
|
|---|---|---|---|
|
Results of Cognitive Testing (EpiTrack© by UCB) - Categories at V6
Without pathological findings
|
38 participants
|
34 participants
|
31 participants
|
|
Results of Cognitive Testing (EpiTrack© by UCB) - Categories at V6
Borderline
|
10 participants
|
17 participants
|
15 participants
|
|
Results of Cognitive Testing (EpiTrack© by UCB) - Categories at V6
Impaired
|
36 participants
|
33 participants
|
39 participants
|
SECONDARY outcome
Timeframe: week 58Population: Patients of ITT population with data at V6 and V0
Evaluation of Changes Changes in the EpiTrack® Score were categorized as follows: ≥5 score points: Improved; -3 to 4 score points: Unchanged; ≤-4 score points: Worsened
Outcome measures
| Measure |
Levetiracetam
n=82 Participants
Levetiracetam 250mg
|
Carbamazepine
n=80 Participants
Carbamazepine 100mg
|
Lamotrigine
n=81 Participants
Lamotrigine 25mg
|
|---|---|---|---|
|
Results of Cognitive Testing (EpiTrack© by UCB) - Changes to Baseline (V0) at Week 58 (V6)
Improved
|
15 participants
|
16 participants
|
15 participants
|
|
Results of Cognitive Testing (EpiTrack© by UCB) - Changes to Baseline (V0) at Week 58 (V6)
Unchanged
|
61 participants
|
56 participants
|
53 participants
|
|
Results of Cognitive Testing (EpiTrack© by UCB) - Changes to Baseline (V0) at Week 58 (V6)
Worsened
|
6 participants
|
8 participants
|
13 participants
|
Adverse Events
Levetiracetam
Serious events: 33 serious events
Other events: 108 other events
Deaths: 0 deaths
Carbamazepine
Serious events: 36 serious events
Other events: 108 other events
Deaths: 0 deaths
Lamotrigine
Serious events: 32 serious events
Other events: 110 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Levetiracetam
n=122 participants at risk
Levetiracetam 250mg
|
Carbamazepine
n=121 participants at risk
Carbamazepine 100mg
|
Lamotrigine
n=117 participants at risk
Lamotrigine 25mg
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.82%
1/122 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Cardiac disorders
Acute coronary syndrome
|
0.82%
1/122 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.83%
1/121 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Cardiac disorders
Acute mycardial infarction
|
1.6%
2/122 • Number of events 2 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.85%
1/117 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.85%
1/117 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
|
Cardiac disorders
Cardiac failure acute
|
0.82%
1/122 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Cardiac disorders
Coronary artery disease
|
0.82%
1/122 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Cardiac disorders
Coronary artery occlusion
|
0.82%
1/122 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Cardiac disorders
Myocardial infarction
|
0.82%
1/122 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.85%
1/117 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.85%
1/117 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
|
Ear and labyrinth disorders
Vertigo
|
0.82%
1/122 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Eye disorders
Macular hole
|
0.82%
1/122 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Eye disorders
Visual impairment
|
0.82%
1/122 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.83%
1/121 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.83%
1/121 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.83%
1/121 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.83%
1/121 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.85%
1/117 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.82%
1/122 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.83%
1/121 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.83%
1/121 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.83%
1/121 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.82%
1/122 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.83%
1/121 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.85%
1/117 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.83%
1/121 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
General disorders
Death
|
0.82%
1/122 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.83%
1/121 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
General disorders
Facial pain
|
0.82%
1/122 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
General disorders
Gait disturbance
|
0.82%
1/122 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
General disorders
Hernia
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.85%
1/117 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
|
General disorders
Pain
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.83%
1/121 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.83%
1/121 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.83%
1/121 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.83%
1/121 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.83%
1/121 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.85%
1/117 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
|
Infections and infestations
Bronchopneumonia
|
0.82%
1/122 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.83%
1/121 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.85%
1/117 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.85%
1/117 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
|
Infections and infestations
Infection
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.83%
1/121 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Infections and infestations
Infectious peritonitis
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.83%
1/121 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Infections and infestations
Pneumonia
|
0.82%
1/122 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.83%
1/121 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.85%
1/117 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
1.7%
2/117 • Number of events 2 • Adverse events were recorded from day 1 of treatment
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.85%
1/117 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.83%
1/121 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Injury, poisoning and procedural complications
Contusion
|
0.82%
1/122 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.85%
1/117 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.85%
1/117 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.85%
1/117 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
|
Injury, poisoning and procedural complications
In-stent coronary artery restenosis
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.85%
1/117 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.82%
1/122 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.82%
1/122 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.85%
1/117 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.85%
1/117 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.85%
1/117 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
|
Investigations
Arthroscopy
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.83%
1/121 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Investigations
Blood potassium decreased
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.83%
1/121 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Investigations
Blood sodium decreased
|
0.82%
1/122 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.83%
1/121 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Investigations
Helicobacter test positive
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.85%
1/117 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.83%
1/121 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Investigations
Weight decreased
|
0.82%
1/122 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.83%
1/121 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.85%
1/117 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.83%
1/121 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.82%
1/122 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anaplastic astrocytoma
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.85%
1/117 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.85%
1/117 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.82%
1/122 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.83%
1/121 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic bronchial carcinoma
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.83%
1/121 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.83%
1/121 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Nervous system disorders
Amnestic disorder
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.85%
1/117 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
|
Nervous system disorders
Brain stem infarction
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.83%
1/121 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.85%
1/117 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.83%
1/121 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.85%
1/117 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
|
Nervous system disorders
Cerebral infarction
|
0.82%
1/122 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Nervous system disorders
Cerebral ischaemia
|
0.82%
1/122 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Nervous system disorders
Cerebrovascular accident
|
0.82%
1/122 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Nervous system disorders
Complex partial seizures
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.83%
1/121 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.85%
1/117 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
|
Nervous system disorders
Convulsion
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
1.7%
2/121 • Number of events 2 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Nervous system disorders
Dementia
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.83%
1/121 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Nervous system disorders
Dizziness
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.83%
1/121 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Nervous system disorders
Epilepsy
|
3.3%
4/122 • Number of events 4 • Adverse events were recorded from day 1 of treatment
|
0.83%
1/121 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Nervous system disorders
Grand mal convulsion
|
0.82%
1/122 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
4.3%
5/117 • Number of events 7 • Adverse events were recorded from day 1 of treatment
|
|
Nervous system disorders
Headache
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.83%
1/121 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.85%
1/117 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
|
Nervous system disorders
Hemiparesis
|
0.82%
1/122 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.83%
1/121 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Nervous system disorders
Loss of consciousness
|
1.6%
2/122 • Number of events 2 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.85%
1/117 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
|
Nervous system disorders
Partial seizures
|
1.6%
2/122 • Number of events 2 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Nervous system disorders
Partial seizures with secondary generalisation
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.83%
1/121 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Nervous system disorders
Speech disorder
|
0.82%
1/122 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Nervous system disorders
Status epilepticus
|
0.82%
1/122 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Nervous system disorders
Stupor
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.85%
1/117 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
|
Nervous system disorders
Transient ischaemic attack
|
0.82%
1/122 • Number of events 2 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.85%
1/117 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
|
Psychiatric disorders
Completed suicide
|
0.82%
1/122 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Psychiatric disorders
Confusional state
|
0.82%
1/122 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.83%
1/121 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.85%
1/117 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
|
Psychiatric disorders
Delirium
|
0.82%
1/122 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Psychiatric disorders
Depression
|
1.6%
2/122 • Number of events 2 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Psychiatric disorders
Suicidal behavior
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.85%
1/117 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
|
Renal and urinary disorders
Renal failure acute
|
0.82%
1/122 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.85%
1/117 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.82%
1/122 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.85%
1/117 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.85%
1/117 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.83%
1/121 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
1.7%
2/117 • Number of events 2 • Adverse events were recorded from day 1 of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.83%
1/121 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.83%
1/121 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.83%
1/121 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.82%
1/122 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Surgical and medical procedures
Bursa removal
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.85%
1/117 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
|
Surgical and medical procedures
Cataract operation
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.85%
1/117 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
|
Surgical and medical procedures
Meningioma surgery
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.85%
1/117 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
|
Surgical and medical procedures
Radiotherapy
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.85%
1/117 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
|
Vascular disorders
Deep vein thrombosis
|
0.82%
1/122 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.83%
1/121 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Vascular disorders
Hypertension
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.83%
1/121 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
0.83%
1/121 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
|
Vascular disorders
Temporal arteritis
|
0.82%
1/122 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/117 • Adverse events were recorded from day 1 of treatment
|
Other adverse events
| Measure |
Levetiracetam
n=122 participants at risk
Levetiracetam 250mg
|
Carbamazepine
n=121 participants at risk
Carbamazepine 100mg
|
Lamotrigine
n=117 participants at risk
Lamotrigine 25mg
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
1.6%
2/122 • Number of events 2 • Adverse events were recorded from day 1 of treatment
|
12.4%
15/121 • Number of events 16 • Adverse events were recorded from day 1 of treatment
|
4.3%
5/117 • Number of events 5 • Adverse events were recorded from day 1 of treatment
|
|
Gastrointestinal disorders
Diarrhoea
|
7.4%
9/122 • Number of events 11 • Adverse events were recorded from day 1 of treatment
|
10.7%
13/121 • Number of events 14 • Adverse events were recorded from day 1 of treatment
|
12.0%
14/117 • Number of events 17 • Adverse events were recorded from day 1 of treatment
|
|
Gastrointestinal disorders
Dry mouth
|
0.82%
1/122 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
4.1%
5/121 • Number of events 5 • Adverse events were recorded from day 1 of treatment
|
6.0%
7/117 • Number of events 8 • Adverse events were recorded from day 1 of treatment
|
|
Gastrointestinal disorders
Nausea
|
9.0%
11/122 • Number of events 15 • Adverse events were recorded from day 1 of treatment
|
14.9%
18/121 • Number of events 21 • Adverse events were recorded from day 1 of treatment
|
14.5%
17/117 • Number of events 23 • Adverse events were recorded from day 1 of treatment
|
|
Gastrointestinal disorders
Vomiting
|
4.1%
5/122 • Number of events 10 • Adverse events were recorded from day 1 of treatment
|
5.0%
6/121 • Number of events 11 • Adverse events were recorded from day 1 of treatment
|
6.0%
7/117 • Number of events 7 • Adverse events were recorded from day 1 of treatment
|
|
General disorders
Fatigue
|
25.4%
31/122 • Number of events 48 • Adverse events were recorded from day 1 of treatment
|
38.0%
46/121 • Number of events 51 • Adverse events were recorded from day 1 of treatment
|
19.7%
23/117 • Number of events 29 • Adverse events were recorded from day 1 of treatment
|
|
General disorders
Gait disturbance
|
6.6%
8/122 • Number of events 8 • Adverse events were recorded from day 1 of treatment
|
8.3%
10/121 • Number of events 11 • Adverse events were recorded from day 1 of treatment
|
4.3%
5/117 • Number of events 6 • Adverse events were recorded from day 1 of treatment
|
|
Infections and infestations
Bronchitis
|
0.00%
0/122 • Adverse events were recorded from day 1 of treatment
|
1.7%
2/121 • Number of events 2 • Adverse events were recorded from day 1 of treatment
|
6.0%
7/117 • Number of events 7 • Adverse events were recorded from day 1 of treatment
|
|
Infections and infestations
Nasopharyngitis
|
16.4%
20/122 • Number of events 26 • Adverse events were recorded from day 1 of treatment
|
10.7%
13/121 • Number of events 18 • Adverse events were recorded from day 1 of treatment
|
6.8%
8/117 • Number of events 10 • Adverse events were recorded from day 1 of treatment
|
|
Infections and infestations
Urinary tract infection
|
2.5%
3/122 • Number of events 3 • Adverse events were recorded from day 1 of treatment
|
5.0%
6/121 • Number of events 6 • Adverse events were recorded from day 1 of treatment
|
0.85%
1/117 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
|
Injury, poisoning and procedural complications
Fall
|
0.82%
1/122 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
4.1%
5/121 • Number of events 7 • Adverse events were recorded from day 1 of treatment
|
5.1%
6/117 • Number of events 6 • Adverse events were recorded from day 1 of treatment
|
|
Investigations
Gamma-glutamyltransferase increased
|
3.3%
4/122 • Number of events 4 • Adverse events were recorded from day 1 of treatment
|
14.9%
18/121 • Number of events 20 • Adverse events were recorded from day 1 of treatment
|
4.3%
5/117 • Number of events 5 • Adverse events were recorded from day 1 of treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.7%
7/122 • Number of events 7 • Adverse events were recorded from day 1 of treatment
|
5.0%
6/121 • Number of events 7 • Adverse events were recorded from day 1 of treatment
|
8.5%
10/117 • Number of events 14 • Adverse events were recorded from day 1 of treatment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.4%
9/122 • Number of events 11 • Adverse events were recorded from day 1 of treatment
|
3.3%
4/121 • Number of events 4 • Adverse events were recorded from day 1 of treatment
|
6.0%
7/117 • Number of events 8 • Adverse events were recorded from day 1 of treatment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.6%
2/122 • Number of events 2 • Adverse events were recorded from day 1 of treatment
|
2.5%
3/121 • Number of events 3 • Adverse events were recorded from day 1 of treatment
|
6.8%
8/117 • Number of events 9 • Adverse events were recorded from day 1 of treatment
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.6%
8/122 • Number of events 8 • Adverse events were recorded from day 1 of treatment
|
1.7%
2/121 • Number of events 2 • Adverse events were recorded from day 1 of treatment
|
6.0%
7/117 • Number of events 12 • Adverse events were recorded from day 1 of treatment
|
|
Nervous system disorders
Convulsion
|
4.1%
5/122 • Number of events 5 • Adverse events were recorded from day 1 of treatment
|
5.8%
7/121 • Number of events 9 • Adverse events were recorded from day 1 of treatment
|
9.4%
11/117 • Number of events 23 • Adverse events were recorded from day 1 of treatment
|
|
Nervous system disorders
Dizziness
|
28.7%
35/122 • Number of events 52 • Adverse events were recorded from day 1 of treatment
|
25.6%
31/121 • Number of events 35 • Adverse events were recorded from day 1 of treatment
|
30.8%
36/117 • Number of events 44 • Adverse events were recorded from day 1 of treatment
|
|
Nervous system disorders
Epilepsy
|
15.6%
19/122 • Number of events 35 • Adverse events were recorded from day 1 of treatment
|
9.1%
11/121 • Number of events 16 • Adverse events were recorded from day 1 of treatment
|
12.0%
14/117 • Number of events 22 • Adverse events were recorded from day 1 of treatment
|
|
Nervous system disorders
Grand mal convulsion
|
0.82%
1/122 • Number of events 1 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
6.0%
7/117 • Number of events 14 • Adverse events were recorded from day 1 of treatment
|
|
Nervous system disorders
Headache
|
25.4%
31/122 • Number of events 46 • Adverse events were recorded from day 1 of treatment
|
24.0%
29/121 • Number of events 39 • Adverse events were recorded from day 1 of treatment
|
24.8%
29/117 • Number of events 44 • Adverse events were recorded from day 1 of treatment
|
|
Nervous system disorders
Memory impairment
|
4.1%
5/122 • Number of events 6 • Adverse events were recorded from day 1 of treatment
|
5.8%
7/121 • Number of events 7 • Adverse events were recorded from day 1 of treatment
|
4.3%
5/117 • Number of events 6 • Adverse events were recorded from day 1 of treatment
|
|
Nervous system disorders
Partial seizures
|
0.82%
1/122 • Number of events 3 • Adverse events were recorded from day 1 of treatment
|
4.1%
5/121 • Number of events 19 • Adverse events were recorded from day 1 of treatment
|
6.8%
8/117 • Number of events 10 • Adverse events were recorded from day 1 of treatment
|
|
Nervous system disorders
Tremor
|
4.9%
6/122 • Number of events 6 • Adverse events were recorded from day 1 of treatment
|
4.1%
5/121 • Number of events 6 • Adverse events were recorded from day 1 of treatment
|
5.1%
6/117 • Number of events 10 • Adverse events were recorded from day 1 of treatment
|
|
Psychiatric disorders
Depression
|
3.3%
4/122 • Number of events 5 • Adverse events were recorded from day 1 of treatment
|
5.0%
6/121 • Number of events 6 • Adverse events were recorded from day 1 of treatment
|
3.4%
4/117 • Number of events 4 • Adverse events were recorded from day 1 of treatment
|
|
Nervous system disorders
Sleep disorder
|
3.3%
4/122 • Number of events 5 • Adverse events were recorded from day 1 of treatment
|
4.1%
5/121 • Number of events 5 • Adverse events were recorded from day 1 of treatment
|
7.7%
9/117 • Number of events 10 • Adverse events were recorded from day 1 of treatment
|
|
Renal and urinary disorders
Renal failure
|
7.4%
9/122 • Number of events 9 • Adverse events were recorded from day 1 of treatment
|
0.00%
0/121 • Adverse events were recorded from day 1 of treatment
|
6.8%
8/117 • Number of events 8 • Adverse events were recorded from day 1 of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.4%
9/122 • Number of events 10 • Adverse events were recorded from day 1 of treatment
|
7.4%
9/121 • Number of events 9 • Adverse events were recorded from day 1 of treatment
|
6.8%
8/117 • Number of events 8 • Adverse events were recorded from day 1 of treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.1%
5/122 • Number of events 5 • Adverse events were recorded from day 1 of treatment
|
8.3%
10/121 • Number of events 10 • Adverse events were recorded from day 1 of treatment
|
7.7%
9/117 • Number of events 9 • Adverse events were recorded from day 1 of treatment
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.7%
7/122 • Number of events 7 • Adverse events were recorded from day 1 of treatment
|
5.0%
6/121 • Number of events 8 • Adverse events were recorded from day 1 of treatment
|
1.7%
2/117 • Number of events 2 • Adverse events were recorded from day 1 of treatment
|
Additional Information
C. Ruckes
Interdisciplinary Center for Clinical Trials (IZKS Mainz)
Phone: +49 (0) 6131 17
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee This study was supported (as investigator-initated trial) by an educational grant from UCB GmbH, Germany. A disclosure restriction applies on the PI in that UCB can review results communications prior to public release and can embargo communications regarding trial results for a period of 90 days from the time submitted. As of Jan-01-2012 the study chair is an employee to UCB Biosciences GmbH working as Medical Director in the Therapeutic Area CNS within Global Projects and Development.
- Publication restrictions are in place
Restriction type: OTHER