There are no guidelines on the first maintenance daily dose of antiepileptic drugs (AEDs) in newly diagnosed, previously untreated epilepsy. Original trials and Cochrane reviews show that seizure remission can be achieved with differing daily doses. In clinical practice, the first maintenance dose varies significantly. In contrast, the risk of adverse treatment effects increases with dosage. There is thus the need to identify the lowest effective dose for treatment start. This background prompted us to undertake a randomized multicenter pragmatic non-inferiority trial comparing standard to low daily doses of AEDs to demonstrate that low doses are at least as effective as standard doses (as indicated by the national formulary) but are better tolerated and are associated with a better quality of life. If proven as effective as the standard dose, a low daily dose of AEDs is a benefit to the patient in terms of tolerability and safety and a source of savings for the National Health System.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
58
Carbamazepine, 300 mg/die
Carbamazepine 600 mg/die
Levetiracetam 500 mg/die
Levetiracetam 1000 mg/die
Valproate 300 mg/die
Valproate 600 mg/die
Zonisamide 150 mg/die
Zonisamide 300 mg/die
Oxcarbazepine 600 mg/die
Oxcarbazepine 1200 mg/die
Topiramate 100 mg/die
Topiramate 200 mg/die
Lamotrigine 100 mg/die
Lamotrigine 200 mg/die
Gabapentin 450 mg/die
Gabapentin 900 mg/die
ASST Monza Ospedale San Gerardo
Monza, Italy
Treatment Failure
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.
Time frame: 12 months
Drug-related Adverse Events
the proportion of patients experiencing a treatment failure motivated by intolerable drug-related adverse events during the follow-up;
Time frame: 12 months
PSQ-18, Italian Version
The 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).
Time frame: 12 months
QoLIE-31, Italian Version
QoLIE-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.
Time frame: 12 months
Health Care Resources Utilization.
The mean daily patient's cost of health care resources consumed for the management of epilepsy during the first 12 months of the study.
Time frame: 12 months
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