Trial Outcomes & Findings for Low vs. Standard Daily Doses of Antiepileptic Drugs in Newly Diagnosed, Previously Untreated Epilepsy(STANDLOW) (NCT NCT03689114)
NCT ID: NCT03689114
Last Updated: 2025-07-08
Results Overview
The proportion of patients experiencing a treatment failure motivated by the need to change the assigned dose or the assigned drug for seizure relapse during the follow-up. All proportions are reported as percentages.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
58 participants
Primary outcome timeframe
12 months
Results posted on
2025-07-08
Participant Flow
The pre-planned sample size of 374 participants was not reached due to COVID-19 pandemic and difficulties of each center in satisfying the inclusion criteria. The total number of enrolled and randomized patients was 58.
Participant milestones
| Measure |
Low Dose
Dosage is in mg: low dose carbamazepine, 300 ; low dose levetiracetam, 500; low dose valproate, 300; low dose zonisamide, 150; low dose oxcarbazepine, 600; low dose topiramate, 100; low dose lamotrigine, 100; low dose gabapentin, 450. Study drugs are in form of tablets for daily administration. Study drug administration duration is 12 months. The choice of the drug is left to the caring physician's discretion but it must be limited to the AEDs marketed for monotherapy use. All the study drugs will be used according to the respective SPCs, which will be sent by the promoter to all the study investigators.
Low dose carbamazepine: Carbamazepine, 300 mg/die
Low dose levetiracetam: Levetiracetam 500 mg/die
Low dose valproate: Valproate 300 mg/die
Low dose zonisamide: Zonisamide 150 mg/die
Low dose oxcarbazepine: Oxcarbazepine 600 mg/die
Low dose topiramate: Topiramate 100 mg/die
Low dose lamotrigine: Lamotrigine 100 mg/die
Low dose gabapentin: Gabapentin 450 mg/die
|
Standard Dose
Dosage is in mg: standard dose carbamazepine 600; standard dose levetiracetam 1000; standard dose valproate, 600; standard dose zonisamide 300; standard dose oxcarbazepine 1200; standard dose topiramate, 200; standard dose lamotrigine, 200; standard dose gabapentin 900. Study drugs are in form of tablets for daily administration. Study drug administration duration is 12 months. The choice of the drug is left to the caring physician's discretion but it must be limited to the AEDs marketed for monotherapy use. All the study drugs will be used according to the respective SPCs, which will be sent by the promoter to all the study investigators.
Standard dose carbamazepine: Carbamazepine 600 mg/die
Standard dose levetiracetam: Levetiracetam 1000 mg/die
Standard dose valproate: Valproate 600 mg/die
Standard dose zonisamide: Zonisamide 300 mg/die
Standard dose oxcarbazepine: Oxcarbazepine 1200 mg/die
Standard dose topiramate: Topiramate 200 mg/die
Standard dose lamotrigine: Lamotrigine 200 mg/die
Standard dose gabapentin: Gabapentin 900 mg/die
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
29
|
|
Overall Study
COMPLETED
|
27
|
25
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Low Dose
n=29 Participants
Dosage is in mg: low dose carbamazepine, 300 ; low dose levetiracetam, 500; low dose valproate, 300; low dose zonisamide, 150; low dose oxcarbazepine, 600; low dose topiramate, 100; low dose lamotrigine, 100; low dose gabapentin, 450. Study drugs are in form of tablets for daily administration. Study drug administration duration is 12 months. The choice of the drug is left to the caring physician's discretion but it must be limited to the AEDs marketed for monotherapy use. All the study drugs will be used according to the respective SPCs, which will be sent by the promoter to all the study investigators.
Low dose carbamazepine: Carbamazepine, 300 mg/die
Low dose levetiracetam: Levetiracetam 500 mg/die
Low dose valproate: Valproate 300 mg/die
Low dose zonisamide: Zonisamide 150 mg/die
Low dose oxcarbazepine: Oxcarbazepine 600 mg/die
Low dose topiramate: Topiramate 100 mg/die
Low dose lamotrigine: Lamotrigine 100 mg/die
Low dose gabapentin: Gabapentin 450 mg/die
|
Standard Dose
n=29 Participants
Dosage is in mg: standard dose carbamazepine 600; standard dose levetiracetam 1000; standard dose valproate, 600; standard dose zonisamide 300; standard dose oxcarbazepine 1200; standard dose topiramate, 200; standard dose lamotrigine, 200; standard dose gabapentin 900. Study drugs are in form of tablets for daily administration. Study drug administration duration is 12 months. The choice of the drug is left to the caring physician's discretion but it must be limited to the AEDs marketed for monotherapy use. All the study drugs will be used according to the respective SPCs, which will be sent by the promoter to all the study investigators.
Standard dose carbamazepine: Carbamazepine 600 mg/die
Standard dose levetiracetam: Levetiracetam 1000 mg/die
Standard dose valproate: Valproate 600 mg/die
Standard dose zonisamide: Zonisamide 300 mg/die
Standard dose oxcarbazepine: Oxcarbazepine 1200 mg/die
Standard dose topiramate: Topiramate 200 mg/die
Standard dose lamotrigine: Lamotrigine 200 mg/die
Standard dose gabapentin: Gabapentin 900 mg/die
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.6 years
n=29 Participants
|
55.5 years
n=29 Participants
|
54.9 years
n=58 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=29 Participants
|
12 Participants
n=29 Participants
|
27 Participants
n=58 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=29 Participants
|
17 Participants
n=29 Participants
|
31 Participants
n=58 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Italy
|
29 participants
n=29 Participants
|
29 participants
n=29 Participants
|
58 participants
n=58 Participants
|
|
Type of seizures
aware
|
10 Participants
n=29 Participants
|
4 Participants
n=29 Participants
|
14 Participants
n=58 Participants
|
|
Type of seizures
impaired awareness
|
19 Participants
n=29 Participants
|
25 Participants
n=29 Participants
|
44 Participants
n=58 Participants
|
|
Seizure frequency
<2/month
|
20 Participants
n=29 Participants
|
21 Participants
n=29 Participants
|
41 Participants
n=58 Participants
|
|
Seizure frequency
2-5/month
|
4 Participants
n=29 Participants
|
4 Participants
n=29 Participants
|
8 Participants
n=58 Participants
|
|
Seizure frequency
6-10/month
|
2 Participants
n=29 Participants
|
1 Participants
n=29 Participants
|
3 Participants
n=58 Participants
|
|
Seizure frequency
>10/month
|
3 Participants
n=29 Participants
|
2 Participants
n=29 Participants
|
5 Participants
n=58 Participants
|
|
Seizure frequency
not specified
|
0 Participants
n=29 Participants
|
1 Participants
n=29 Participants
|
1 Participants
n=58 Participants
|
|
Etiology
Structural
|
5 Participants
n=29 Participants
|
10 Participants
n=29 Participants
|
15 Participants
n=58 Participants
|
|
Etiology
Unknown
|
24 Participants
n=29 Participants
|
19 Participants
n=29 Participants
|
43 Participants
n=58 Participants
|
|
PSQ-18
General satisfaction
|
5 units on a scale
n=29 Participants
|
4 units on a scale
n=29 Participants
|
4 units on a scale
n=58 Participants
|
|
PSQ-18
Technical quality
|
4 units on a scale
n=29 Participants
|
4 units on a scale
n=29 Participants
|
4 units on a scale
n=58 Participants
|
|
PSQ-18
Interpersonal manner
|
4 units on a scale
n=29 Participants
|
4 units on a scale
n=29 Participants
|
4 units on a scale
n=58 Participants
|
|
PSQ-18
Communication
|
4 units on a scale
n=29 Participants
|
5 units on a scale
n=29 Participants
|
4.5 units on a scale
n=58 Participants
|
|
PSQ-18
Financial aspects
|
4 units on a scale
n=29 Participants
|
4 units on a scale
n=29 Participants
|
4 units on a scale
n=58 Participants
|
|
PSQ-18
Time spent with doctors
|
4 units on a scale
n=29 Participants
|
4 units on a scale
n=29 Participants
|
4 units on a scale
n=58 Participants
|
|
PSQ-18
Accessibility and convenience
|
4 units on a scale
n=29 Participants
|
4 units on a scale
n=29 Participants
|
4 units on a scale
n=58 Participants
|
|
Qolie 31
|
69 units on a scale
n=29 Participants
|
60 units on a scale
n=29 Participants
|
64 units on a scale
n=58 Participants
|
|
Time from first symptoms to diagnosis
|
5.7 months
n=29 Participants
|
3.2 months
n=29 Participants
|
4.6 months
n=58 Participants
|
PRIMARY outcome
Timeframe: 12 monthsThe proportion of patients experiencing a treatment failure motivated by the need to change the assigned dose or the assigned drug for seizure relapse during the follow-up. All proportions are reported as percentages.
Outcome measures
| Measure |
Low Dose
n=29 Participants
Dosage is in mg: low dose carbamazepine, 300 ; low dose levetiracetam, 500; low dose valproate, 300; low dose zonisamide, 150; low dose oxcarbazepine, 600; low dose topiramate, 100; low dose lamotrigine, 100; low dose gabapentin, 450. Study drugs are in form of tablets for daily administration. Study drug administration duration is 12 months. The choice of the drug is left to the caring physician's discretion but it must be limited to the AEDs marketed for monotherapy use. All the study drugs will be used according to the respective SPCs, which will be sent by the promoter to all the study investigators.
Low dose carbamazepine: Carbamazepine, 300 mg/die
Low dose levetiracetam: Levetiracetam 500 mg/die
Low dose valproate: Valproate 300 mg/die
Low dose zonisamide: Zonisamide 150 mg/die
Low dose oxcarbazepine: Oxcarbazepine 600 mg/die
Low dose topiramate: Topiramate 100 mg/die
Low dose lamotrigine: Lamotrigine 100 mg/die
Low dose gabapentin: Gabapentin 450 mg/die
|
Standard Dose
n=29 Participants
Dosage is in mg: standard dose carbamazepine 600; standard dose levetiracetam 1000; standard dose valproate, 600; standard dose zonisamide 300; standard dose oxcarbazepine 1200; standard dose topiramate, 200; standard dose lamotrigine, 200; standard dose gabapentin 900. Study drugs are in form of tablets for daily administration. Study drug administration duration is 12 months. The choice of the drug is left to the caring physician's discretion but it must be limited to the AEDs marketed for monotherapy use. All the study drugs will be used according to the respective SPCs, which will be sent by the promoter to all the study investigators.
Standard dose carbamazepine: Carbamazepine 600 mg/die
Standard dose levetiracetam: Levetiracetam 1000 mg/die
Standard dose valproate: Valproate 600 mg/die
Standard dose zonisamide: Zonisamide 300 mg/die
Standard dose oxcarbazepine: Oxcarbazepine 1200 mg/die
Standard dose topiramate: Topiramate 200 mg/die
Standard dose lamotrigine: Lamotrigine 200 mg/die
Standard dose gabapentin: Gabapentin 900 mg/die
|
|---|---|---|
|
Treatment Failure
|
11 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 12 monthsthe proportion of patients experiencing a treatment failure motivated by intolerable drug-related adverse events during the follow-up;
Outcome measures
| Measure |
Low Dose
n=29 Participants
Dosage is in mg: low dose carbamazepine, 300 ; low dose levetiracetam, 500; low dose valproate, 300; low dose zonisamide, 150; low dose oxcarbazepine, 600; low dose topiramate, 100; low dose lamotrigine, 100; low dose gabapentin, 450. Study drugs are in form of tablets for daily administration. Study drug administration duration is 12 months. The choice of the drug is left to the caring physician's discretion but it must be limited to the AEDs marketed for monotherapy use. All the study drugs will be used according to the respective SPCs, which will be sent by the promoter to all the study investigators.
Low dose carbamazepine: Carbamazepine, 300 mg/die
Low dose levetiracetam: Levetiracetam 500 mg/die
Low dose valproate: Valproate 300 mg/die
Low dose zonisamide: Zonisamide 150 mg/die
Low dose oxcarbazepine: Oxcarbazepine 600 mg/die
Low dose topiramate: Topiramate 100 mg/die
Low dose lamotrigine: Lamotrigine 100 mg/die
Low dose gabapentin: Gabapentin 450 mg/die
|
Standard Dose
n=29 Participants
Dosage is in mg: standard dose carbamazepine 600; standard dose levetiracetam 1000; standard dose valproate, 600; standard dose zonisamide 300; standard dose oxcarbazepine 1200; standard dose topiramate, 200; standard dose lamotrigine, 200; standard dose gabapentin 900. Study drugs are in form of tablets for daily administration. Study drug administration duration is 12 months. The choice of the drug is left to the caring physician's discretion but it must be limited to the AEDs marketed for monotherapy use. All the study drugs will be used according to the respective SPCs, which will be sent by the promoter to all the study investigators.
Standard dose carbamazepine: Carbamazepine 600 mg/die
Standard dose levetiracetam: Levetiracetam 1000 mg/die
Standard dose valproate: Valproate 600 mg/die
Standard dose zonisamide: Zonisamide 300 mg/die
Standard dose oxcarbazepine: Oxcarbazepine 1200 mg/die
Standard dose topiramate: Topiramate 200 mg/die
Standard dose lamotrigine: Lamotrigine 200 mg/die
Standard dose gabapentin: Gabapentin 900 mg/die
|
|---|---|---|
|
Drug-related Adverse Events
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 12 monthsThe score of the seven Patients Satisfaction Questionnaire 18 items (PSQ-18) subscales (general satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with doctor, accessibility and convenience) at the last visit; the score of each subscale ranges from 1 (worst) to 5 (best).
Outcome measures
| Measure |
Low Dose
n=20 Participants
Dosage is in mg: low dose carbamazepine, 300 ; low dose levetiracetam, 500; low dose valproate, 300; low dose zonisamide, 150; low dose oxcarbazepine, 600; low dose topiramate, 100; low dose lamotrigine, 100; low dose gabapentin, 450. Study drugs are in form of tablets for daily administration. Study drug administration duration is 12 months. The choice of the drug is left to the caring physician's discretion but it must be limited to the AEDs marketed for monotherapy use. All the study drugs will be used according to the respective SPCs, which will be sent by the promoter to all the study investigators.
Low dose carbamazepine: Carbamazepine, 300 mg/die
Low dose levetiracetam: Levetiracetam 500 mg/die
Low dose valproate: Valproate 300 mg/die
Low dose zonisamide: Zonisamide 150 mg/die
Low dose oxcarbazepine: Oxcarbazepine 600 mg/die
Low dose topiramate: Topiramate 100 mg/die
Low dose lamotrigine: Lamotrigine 100 mg/die
Low dose gabapentin: Gabapentin 450 mg/die
|
Standard Dose
n=17 Participants
Dosage is in mg: standard dose carbamazepine 600; standard dose levetiracetam 1000; standard dose valproate, 600; standard dose zonisamide 300; standard dose oxcarbazepine 1200; standard dose topiramate, 200; standard dose lamotrigine, 200; standard dose gabapentin 900. Study drugs are in form of tablets for daily administration. Study drug administration duration is 12 months. The choice of the drug is left to the caring physician's discretion but it must be limited to the AEDs marketed for monotherapy use. All the study drugs will be used according to the respective SPCs, which will be sent by the promoter to all the study investigators.
Standard dose carbamazepine: Carbamazepine 600 mg/die
Standard dose levetiracetam: Levetiracetam 1000 mg/die
Standard dose valproate: Valproate 600 mg/die
Standard dose zonisamide: Zonisamide 300 mg/die
Standard dose oxcarbazepine: Oxcarbazepine 1200 mg/die
Standard dose topiramate: Topiramate 200 mg/die
Standard dose lamotrigine: Lamotrigine 200 mg/die
Standard dose gabapentin: Gabapentin 900 mg/die
|
|---|---|---|
|
PSQ-18, Italian Version
General satisfaction
|
4.5 units on a scale
Interval 3.0 to 5.0
|
4 units on a scale
Interval 3.0 to 4.0
|
|
PSQ-18, Italian Version
Technical quality
|
4 units on a scale
Interval 3.5 to 5.0
|
4 units on a scale
Interval 4.0 to 4.0
|
|
PSQ-18, Italian Version
Interpersonal manner
|
5 units on a scale
Interval 4.0 to 5.0
|
4 units on a scale
Interval 3.0 to 5.0
|
|
PSQ-18, Italian Version
Communication
|
5 units on a scale
Interval 3.5 to 5.0
|
4 units on a scale
Interval 4.0 to 5.0
|
|
PSQ-18, Italian Version
Financial aspects
|
4.5 units on a scale
Interval 4.0 to 5.0
|
4 units on a scale
Interval 4.0 to 5.0
|
|
PSQ-18, Italian Version
Time spent with doctors
|
4 units on a scale
Interval 3.5 to 4.0
|
4 units on a scale
Interval 3.0 to 4.0
|
|
PSQ-18, Italian Version
Accessibility and convenience
|
4 units on a scale
Interval 3.5 to 5.0
|
4 units on a scale
Interval 4.0 to 4.0
|
SECONDARY outcome
Timeframe: 12 monthsQoLIE-31 measures the quality of life of patients with epilepsy (range 0-100, where 0 corresponds to the worst quality of life and 100 corresponds to the best), at the end of study visit.
Outcome measures
| Measure |
Low Dose
n=20 Participants
Dosage is in mg: low dose carbamazepine, 300 ; low dose levetiracetam, 500; low dose valproate, 300; low dose zonisamide, 150; low dose oxcarbazepine, 600; low dose topiramate, 100; low dose lamotrigine, 100; low dose gabapentin, 450. Study drugs are in form of tablets for daily administration. Study drug administration duration is 12 months. The choice of the drug is left to the caring physician's discretion but it must be limited to the AEDs marketed for monotherapy use. All the study drugs will be used according to the respective SPCs, which will be sent by the promoter to all the study investigators.
Low dose carbamazepine: Carbamazepine, 300 mg/die
Low dose levetiracetam: Levetiracetam 500 mg/die
Low dose valproate: Valproate 300 mg/die
Low dose zonisamide: Zonisamide 150 mg/die
Low dose oxcarbazepine: Oxcarbazepine 600 mg/die
Low dose topiramate: Topiramate 100 mg/die
Low dose lamotrigine: Lamotrigine 100 mg/die
Low dose gabapentin: Gabapentin 450 mg/die
|
Standard Dose
n=18 Participants
Dosage is in mg: standard dose carbamazepine 600; standard dose levetiracetam 1000; standard dose valproate, 600; standard dose zonisamide 300; standard dose oxcarbazepine 1200; standard dose topiramate, 200; standard dose lamotrigine, 200; standard dose gabapentin 900. Study drugs are in form of tablets for daily administration. Study drug administration duration is 12 months. The choice of the drug is left to the caring physician's discretion but it must be limited to the AEDs marketed for monotherapy use. All the study drugs will be used according to the respective SPCs, which will be sent by the promoter to all the study investigators.
Standard dose carbamazepine: Carbamazepine 600 mg/die
Standard dose levetiracetam: Levetiracetam 1000 mg/die
Standard dose valproate: Valproate 600 mg/die
Standard dose zonisamide: Zonisamide 300 mg/die
Standard dose oxcarbazepine: Oxcarbazepine 1200 mg/die
Standard dose topiramate: Topiramate 200 mg/die
Standard dose lamotrigine: Lamotrigine 200 mg/die
Standard dose gabapentin: Gabapentin 900 mg/die
|
|---|---|---|
|
QoLIE-31, Italian Version
|
68 units on a scale
Interval 56.5 to 76.5
|
64.5 units on a scale
Interval 55.0 to 78.0
|
SECONDARY outcome
Timeframe: 12 monthsThe mean daily patient's cost of health care resources consumed for the management of epilepsy during the first 12 months of the study.
Outcome measures
| Measure |
Low Dose
n=29 Participants
Dosage is in mg: low dose carbamazepine, 300 ; low dose levetiracetam, 500; low dose valproate, 300; low dose zonisamide, 150; low dose oxcarbazepine, 600; low dose topiramate, 100; low dose lamotrigine, 100; low dose gabapentin, 450. Study drugs are in form of tablets for daily administration. Study drug administration duration is 12 months. The choice of the drug is left to the caring physician's discretion but it must be limited to the AEDs marketed for monotherapy use. All the study drugs will be used according to the respective SPCs, which will be sent by the promoter to all the study investigators.
Low dose carbamazepine: Carbamazepine, 300 mg/die
Low dose levetiracetam: Levetiracetam 500 mg/die
Low dose valproate: Valproate 300 mg/die
Low dose zonisamide: Zonisamide 150 mg/die
Low dose oxcarbazepine: Oxcarbazepine 600 mg/die
Low dose topiramate: Topiramate 100 mg/die
Low dose lamotrigine: Lamotrigine 100 mg/die
Low dose gabapentin: Gabapentin 450 mg/die
|
Standard Dose
n=29 Participants
Dosage is in mg: standard dose carbamazepine 600; standard dose levetiracetam 1000; standard dose valproate, 600; standard dose zonisamide 300; standard dose oxcarbazepine 1200; standard dose topiramate, 200; standard dose lamotrigine, 200; standard dose gabapentin 900. Study drugs are in form of tablets for daily administration. Study drug administration duration is 12 months. The choice of the drug is left to the caring physician's discretion but it must be limited to the AEDs marketed for monotherapy use. All the study drugs will be used according to the respective SPCs, which will be sent by the promoter to all the study investigators.
Standard dose carbamazepine: Carbamazepine 600 mg/die
Standard dose levetiracetam: Levetiracetam 1000 mg/die
Standard dose valproate: Valproate 600 mg/die
Standard dose zonisamide: Zonisamide 300 mg/die
Standard dose oxcarbazepine: Oxcarbazepine 1200 mg/die
Standard dose topiramate: Topiramate 200 mg/die
Standard dose lamotrigine: Lamotrigine 200 mg/die
Standard dose gabapentin: Gabapentin 900 mg/die
|
|---|---|---|
|
Health Care Resources Utilization.
|
252.46 euro
Interval 167.9 to 252.46
|
474.50 euro
Interval 338.92 to 677.86
|
Adverse Events
Low Dose
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Standard Dose
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Low Dose
n=29 participants at risk
Dosage is in mg: low dose carbamazepine, 300; low dose levetiracetam, 500; low dose valproate, 300; low dose zonisamide, 150; low dose oxcarbazepine, 600; low dose topiramate, 100; low dose lamotrigine, 100; low dose gabapentin, 450; low dose lacosamide 100 mg. Study drugs are in form of tablets for daily administration. Study drug administration duration is 12 months. The choice of the drug is left to the caring physician's discretion but it must be limited to the AEDs marketed for monotherapy use. All the study drugs will be used according to the respective SPCs, which will be sent by the promoter to all the study investigators.
The arm/group "low dose" includes all the interventions listed above which correspond to low dose of each antiepileptic monotherapy.
All the results were grouped by arm/group. In the adverse events tables all the single drugs were specified in each arm/group.
The aim of this study was to compare the low dose arm/group versus the standard dose arm/group independently from the specific intervention/drug prescribed by the neurologist. Randomization was done by dose and not by drug. The drug has been chosen by the treating physician.
|
Standard Dose
n=29 participants at risk
Dosage is in mg: standard dose carbamazepine 600; standard dose levetiracetam 1000; standard dose valproate, 600; standard dose zonisamide 300; standard dose oxcarbazepine 1200; standard dose topiramate, 200; standard dose lamotrigine, 200; standard dose gabapentin 900; standard dose lacosamide 200 mg. Study drugs are in form of tablets for daily administration. Study drug administration duration is 12 months. The choice of the drug is left to the caring physician's discretion but it must be limited to the AEDs marketed for monotherapy use. All the study drugs will be used according to the respective SPCs, which will be sent by the promoter to all the study investigators.
The arm/group "standard dose" includes all the interventions listed above which correspond to standard dose of each antiepileptic monotherapy.
All the results were grouped by arm/group. In the adverse events tables all the single drugs were specified in each arm/group.
The aim of this study was to compare the low dose arm/group versus the standard dose arm/group independently from the specific intervention/drug prescribed by the neurologist. Randomization was done by dose and not by drug. The drug has been chosen by the treating physician.
|
|---|---|---|
|
Cardiac disorders
HEART FAILURE
|
3.4%
1/29 • 12 months
|
0.00%
0/29 • 12 months
|
|
Nervous system disorders
DYSARTHRIA
|
3.4%
1/29 • 12 months
|
0.00%
0/29 • 12 months
|
|
Cardiac disorders
OTHER, SPECIFY
|
3.4%
1/29 • 12 months
|
0.00%
0/29 • 12 months
|
|
Nervous system disorders
status epilepticus
|
0.00%
0/29 • 12 months
|
3.4%
1/29 • 12 months
|
Other adverse events
| Measure |
Low Dose
n=29 participants at risk
Dosage is in mg: low dose carbamazepine, 300; low dose levetiracetam, 500; low dose valproate, 300; low dose zonisamide, 150; low dose oxcarbazepine, 600; low dose topiramate, 100; low dose lamotrigine, 100; low dose gabapentin, 450; low dose lacosamide 100 mg. Study drugs are in form of tablets for daily administration. Study drug administration duration is 12 months. The choice of the drug is left to the caring physician's discretion but it must be limited to the AEDs marketed for monotherapy use. All the study drugs will be used according to the respective SPCs, which will be sent by the promoter to all the study investigators.
The arm/group "low dose" includes all the interventions listed above which correspond to low dose of each antiepileptic monotherapy.
All the results were grouped by arm/group. In the adverse events tables all the single drugs were specified in each arm/group.
The aim of this study was to compare the low dose arm/group versus the standard dose arm/group independently from the specific intervention/drug prescribed by the neurologist. Randomization was done by dose and not by drug. The drug has been chosen by the treating physician.
|
Standard Dose
n=29 participants at risk
Dosage is in mg: standard dose carbamazepine 600; standard dose levetiracetam 1000; standard dose valproate, 600; standard dose zonisamide 300; standard dose oxcarbazepine 1200; standard dose topiramate, 200; standard dose lamotrigine, 200; standard dose gabapentin 900; standard dose lacosamide 200 mg. Study drugs are in form of tablets for daily administration. Study drug administration duration is 12 months. The choice of the drug is left to the caring physician's discretion but it must be limited to the AEDs marketed for monotherapy use. All the study drugs will be used according to the respective SPCs, which will be sent by the promoter to all the study investigators.
The arm/group "standard dose" includes all the interventions listed above which correspond to standard dose of each antiepileptic monotherapy.
All the results were grouped by arm/group. In the adverse events tables all the single drugs were specified in each arm/group.
The aim of this study was to compare the low dose arm/group versus the standard dose arm/group independently from the specific intervention/drug prescribed by the neurologist. Randomization was done by dose and not by drug. The drug has been chosen by the treating physician.
|
|---|---|---|
|
Psychiatric disorders
IRRITABILITY
|
3.4%
1/29 • Number of events 1 • 12 months
|
6.9%
2/29 • Number of events 2 • 12 months
|
|
Nervous system disorders
Fatigue
|
6.9%
2/29 • Number of events 2 • 12 months
|
10.3%
3/29 • Number of events 3 • 12 months
|
|
Nervous system disorders
Dizziness
|
6.9%
2/29 • Number of events 2 • 12 months
|
0.00%
0/29 • 12 months
|
|
Eye disorders
rash maculo-papular
|
0.00%
0/29 • 12 months
|
6.9%
2/29 • Number of events 2 • 12 months
|
|
Nervous system disorders
Somnolence
|
13.8%
4/29 • Number of events 4 • 12 months
|
13.8%
4/29 • Number of events 4 • 12 months
|
Additional Information
Giorgia Giussani
Istituto di Ricerche Farmacologiche Mario Negri IRCCS
Phone: 0239014604
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place