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
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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

Criteria

Inclusion Criteria:

1. Age 18 years or older;

2. Newly diagnosed previously untreated epilepsy, defined according to the ILAE definition (Fisher et al, 2014);

3. Having experienced focal seizures, defined according to the ILAE criteria (Commission, 1981);

4. 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:

1. Age less than 18 years;

2. Having experienced primarily or secondarily generalized tonic and/or clonic seizures, or other (non-focal) seizure types;

3. Previous exposure to AEDs;

4. Requiring low or standard doses on account of individual needs;

5. Inability to understand the aims or modalities of the study;

6. 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;

7. Previous treatment with an antiepileptic drug;

8. Men unable to practice contraception for the duration of the treatment.

9. Poor compliance with assigned treatments;

10. Refusal to release written informed consent;

11. 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.