NCT03689114CompletedPhase 4
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
Source: ClinicalTrials.gov · Last updated 8 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 58 (actual)
- First submitted
- 27 Sept 2018
- Start date
- 10 May 2021
- Primary completion date
- 30 Jun 2024
- Lead sponsor
- Mario Negri Institute for Pharmacological Research
- Diseases
- Epilepsy
- NCT number
- NCT03689114
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 58
- From 10 May 2021 to the primary completion date, 30 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous exposure to AEDs;
- Previous treatment with an antiepileptic drug;
- 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.
Other illness
- Having experienced primarily or secondarily generalized tonic and/or clonic seizures, or other (non-focal) seizure types;
Age
- Age less than 18 years;
Other
- A patient will be excluded if at least one of the following criteria will be met:
- 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;
- Men unable to practice contraception for the duration of the treatment.
- Poor compliance with assigned treatments;
- Refusal to release written informed consent;
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| ASST Monza Ospedale San Gerardo Coordinator of this site? Confirm its status | Monza | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.