NCT03689114

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Mario Negri Institute for Pharmacological Research · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Epilepsies, Partial

Interventions

Type	Name	Description
DRUG	Low dose carbamazepine	Carbamazepine, 300 mg/die
DRUG	Standard dose carbamazepine	Carbamazepine 600 mg/die
DRUG	Low dose levetiracetam	Levetiracetam 500 mg/die
DRUG	Standard dose levetiracetam	Levetiracetam 1000 mg/die
DRUG	Low dose valproate	Valproate 300 mg/die
DRUG	Standard dose valproate	Valproate 600 mg/die
DRUG	Low dose zonisamide	Zonisamide 150 mg/die
DRUG	Standard dose zonisamide	Zonisamide 300 mg/die
DRUG	Low dose oxcarbazepine	Oxcarbazepine 600 mg/die
DRUG	Standard dose oxcarbazepine	Oxcarbazepine 1200 mg/die
DRUG	Low dose topiramate	Topiramate 100 mg/die
DRUG	Standard dose topiramate	Topiramate 200 mg/die
DRUG	Low dose lamotrigine	Lamotrigine 100 mg/die
DRUG	Standard dose lamotrigine	Lamotrigine 200 mg/die
DRUG	Low dose gabapentin	Gabapentin 450 mg/die
DRUG	Standard dose gabapentin	Gabapentin 900 mg/die

Timeline

• Start date: 2021-05-10
• Primary completion: 2024-06-30
• Completion: 2024-06-30
• First posted: 2018-09-28
• Last updated: 2025-07-08
• Results posted: 2025-07-08

Locations

1 site across 1 country: Italy