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

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

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

Sponsors & Collaborators

• Azienda Ospedaliera San Gerardo di Monza

  collaborator OTHER

• Ministry of Health, Italy

  collaborator OTHER_GOV

• Mario Negri Institute for Pharmacological Research

  lead OTHER

Principal Investigators

• Ettore Beghi, MD · Istituto Di Ricerche Farmacologiche Mario Negri

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-05-10

Primary Completion

2024-06-30

Completion

2024-06-30

Countries

• Italy

Study Locations