At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Efficacy and Tolerability of Low vs. Standard Daily Doses of Antiepileptic Drugs in Newly Diagnosed, Previously Untreated Epilepsy (STANDLOW). A Multicenter, Randomized, Single-blind, Parallel-group Trial
In Brief
A Phase 4 clinical trial evaluating Low dose carbamazepine, Standard dose carbamazepine, and 14 other interventions for Epilepsies, Partial. Completed, enrolled 58 participants across 1 site.
Detailed Summary
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 Details
Timeline
Interventions
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