Low vs. Standard Daily Doses of Antiepileptic Drugs in Newly Diagnosed, Previously Untreated Epilepsy(STANDLOW)

• Status: Not yet recruiting
• Trial end date: 2021-12-01

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.

• Phase: Phase 4

Details

• Lead Sponsor: Mario Negri Institute for Pharmacological Research
• Collaborators: Azienda Ospedaliera San Gerardo di Monza; Ministry of Health, Italy
• Treatments: Anticonvulsants; Carbamazepine; Gabapentin; Lamotrigine; Levetiracetam; Oxcarbazepine; Topiramate; Valproic Acid; Zonisamide