Effect of mirtazapine on seizure frequency in epileptic patients with vagal nerve stimulation device

Effect of mirtazapine on seizure frequency in medically refractory epileptic patients with vagal nerve stimulation

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-003464-32-HU

Enrollment

Registered

2019-11-08

Start date

2019-11-05

Completion date

Unknown

Last updated

2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

epilepsy

Interventions

Trade Name: MIRZATEN 30 mg filmtabletta Product Name: MIRZATEN 30 mg filmtabletta Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral us

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subject meets the 2009 ILAE definition of drug resistant epilepsy with focal seizures with or without loss of consciousness Vagal nerve stimulation device implanted and activated > 6 month prior to enrollment At least 5 seizure per month Both gendre, subject between 18-65 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Change in AED regimen in the last 6 weeks Active suicidal plan/intent in the past 6 months, or a history of suicide attempt in the last 2 years, or more than 1 lifetime suicide attempt Psychiatric disorder (includin derpession, bipolar disorder, schizophrenia and sever demetia) diagnosed < 1 year prior the enrollment Any condition that may impact a subject’s ability to follow study procedures or subject’s safety, based on what is known about the pharmacology/toxicology profile of the trial agent

Design outcomes

Primary

Measure	Time frame
Main Objective: Study the effect of mirtazapine on seizure frequency in refractory epileptic patients implanted with vagal nerve stimulator;Secondary Objective: Not applicible;Primary end point(s): Changes in seizure frequency;Timepoint(s) of evaluation of this end point: Data from seizure diaries summarized at weeks 12 and 27	—

Secondary

Measure	Time frame
Secondary end point(s): Quality of Life: using the self-administered Quality of Life in Epilepsy 89 (QOLIE-89) Depression: using Beck Depression Inventory (BDI) and Hamilton Depression Rating Scale (HAM-D);Timepoint(s) of evaluation of this end point: At baseline and weeks 12, 15, 27	—

Countries

Hungary

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026