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Completed

NCT Number: NCT03689114

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

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.

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Key information

Conditions

Epilepsies, Partial Brain Diseases Central Nervous System Diseases Epilepsy Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

ASST Monza Ospedale San Gerardo

Monza, 20900, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years or older;
  • Newly diagnosed previously untreated epilepsy, defined according to the ILAE definition (Fisher et al, 2014);
  • Having experienced focal seizures, defined according to the ILAE criteria (Commission, 1981);
  • Able to understand and comply with the study requirements and release a written informed consent.

Exclusion criteria

A patient will be excluded if at least one of the following criteria will be met:

  • Age less than 18 years;
  • Having experienced primarily or secondarily generalized tonic and/or clonic seizures, or other (non-focal) seizure types;
  • Previous exposure to AEDs;
  • Requiring low or standard doses on account of individual needs;
  • Inability to understand the aims or modalities of the study;
  • Current pregnancy or planning to become pregnant during the study period (e.g. who are not post-menopausal, surgically sterile, or using inadequate birth control). A postmenopausal state is defined as no menses for 12 months without an alternative medical cause;
  • Previous treatment with an antiepileptic drug;
  • Men unable to practice contraception for the duration of the treatment.
  • Poor compliance with assigned treatments;
  • Refusal to release written informed consent;
  • The study investigators will receive the summary of product characteristics (SPC) available for each study drug. Patients cannot be enrolled in the study if the contraindications/warnings described in the SPC are met.

Treatment and study plan

Low dose carbamazepine

Drug

Carbamazepine, 300 mg/die

Other names: low carbamazepine

Standard dose carbamazepine

Drug

Carbamazepine 600 mg/die

Other names: Standard carbamazepine

Low dose levetiracetam

Drug

Levetiracetam 500 mg/die

Other names: Low levetiracetam

Standard dose levetiracetam

Drug

Levetiracetam 1000 mg/die

Other names: Standard levetiracetam

Low dose valproate

Drug

Valproate 300 mg/die

Other names: Low valproate

Standard dose valproate

Drug

Valproate 600 mg/die

Other names: Standard valproate

Low dose zonisamide

Drug

Zonisamide 150 mg/die

Other names: Low zonisamide

Standard dose zonisamide

Drug

Zonisamide 300 mg/die

Other names: Standard zonisamide

Low dose oxcarbazepine

Drug

Oxcarbazepine 600 mg/die

Other names: Low oxcarbazepine

Standard dose oxcarbazepine

Drug

Oxcarbazepine 1200 mg/die

Other names: Standard oxcarbazepine

Low dose topiramate

Drug

Topiramate 100 mg/die

Other names: Low topiramate

Standard dose topiramate

Drug

Topiramate 200 mg/die

Other names: Standard topiramate

Low dose lamotrigine

Drug

Lamotrigine 100 mg/die

Other names: Low lamotrigine

Standard dose lamotrigine

Drug

Lamotrigine 200 mg/die

Other names: Standard lamotrigine

Low dose gabapentin

Drug

Gabapentin 450 mg/die

Other names: Low gabapentin

Standard dose gabapentin

Drug

Gabapentin 900 mg/die

Other names: Standard gabapentin

Primary outcomes

  1. Treatment Failure

    Time frame: 12 months

    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.

Secondary outcomes

  1. Drug-related Adverse Events

    Time frame: 12 months

    the proportion of patients experiencing a treatment failure motivated by intolerable drug-related adverse events during the follow-up;

  2. PSQ-18, Italian Version

    Time frame: 12 months

    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).

  3. QoLIE-31, Italian Version

    Time frame: 12 months

    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.

  4. Health Care Resources Utilization.

    Time frame: 12 months

    The mean daily patient's cost of health care resources consumed for the management of epilepsy during the first 12 months of the study.

Sponsors and collaborators

Lead sponsor

Mario Negri Institute for Pharmacological Research

Other

Collaborators

  • Azienda Ospedaliera San Gerardo di Monza
  • Ministry of Health, Italy

Registry information

Official study title

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

Acronym: STANDLOW

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Sep 28, 2018
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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