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ZOREVUNERSEN SODIUM

Clinical trials are studying ZOREVUNERSEN SODIUM in people with Dravet syndrome. These studies aim to evaluate safety, tolerability, and whether the treatment can reduce major motor seizures. The main trial listed here includes patients with this rare seizure disorder.

Table of Contents

Clinical trial overview

The listed study is a Phase 3 clinical trial of ZOREVUNERSEN SODIUM in patients with Dravet syndrome, a rare seizure disorder.[1] The trial is designed to assess efficacy, safety, and tolerability while looking at whether the treatment can reduce major motor seizures.[1]

Study design and treatment groups

This is an interventional study, which means the researchers give a treatment and measure the results.[1] The study is described as double-blind, so the source indicates a design meant to reduce bias in the results.[1] The trial compares ZOREVUNERSEN SODIUM with sham treatment, which is an inactive comparison used to help show whether the study drug has a real effect.[1]

The trial lists two study doses: 45 mg and 70 mg, both given by intrathecal use, meaning treatment is delivered into the fluid around the spinal cord.[1]

Who can join the study

The source data says the trial is for patients with Dravet syndrome.[1] It does not provide more details about age limits, seizure history rules, or other entry criteria, so those parts cannot be confirmed from the source.[1]

What the trial measures

The main endpoint is the percent change from baseline in major motor seizure frequency.[1] Baseline means the starting point before treatment begins.[1] The study measures seizures per 28 days in patients receiving ZOREVUNERSEN SODIUM compared with sham from Week 16 to Week 28, using three 4-week periods.[1]

The trial focuses on major motor seizures, which the source defines as hemiclonic, focal with motor signs, focal to bilateral tonic-clonic, generalized tonic-clonic, tonic, tonic/atonic, and bilateral clonic seizures.[1] In simple terms, these are seizure types that involve strong body movement and may cause falls or whole-body shaking.[1]

Trial status and size

The trial status is listed as Authorised.[1] The planned enrollment is 185 participants, which means the study expects to include 185 people.[1] This size suggests the trial is meant to collect enough data to better judge how the treatment performs in a larger group.[1]

Patient-friendly terms

Efficacy means how well the treatment works.[1] Safety means whether the treatment causes harmful effects.[1] Tolerability means how well patients can receive the treatment without too much trouble or discomfort.[1]

Sham treatment is used as a comparison and does not contain the active study drug.[1] Double-blind means the people in the study and the study team do not know who is getting which treatment, which helps make the results more reliable.[1]

Trial ID Phase Condition studied Status Enrollment
NCT06872125 Phase 3 Dravet syndrome Authorised 185

FAQ

  • What condition is being studied with ZOREVUNERSEN SODIUM? The trial is studying Dravet syndrome, a rare and severe seizure disorder. It looks at whether ZOREVUNERSEN SODIUM can help reduce major motor seizures.
  • Who can take part in the trial? The listed trial is for patients with Dravet syndrome. The source data does not give more details about age or other entry rules.
  • What phase is the trial? The trial is in Phase 3. This means it is a later-stage study that usually looks at how well a treatment works and how safe it is in a larger group.
  • What is the main goal of the study? The main goal is to measure the percent change in major motor seizure frequency compared with sham treatment. The study checks this from Week 16 to Week 28.
  • What treatment is being tested? The trial tests ZOREVUNERSEN SODIUM given by intrathecal use, which means it is delivered into the fluid around the spinal cord. Two dose levels are listed: 45 mg and 70 mg.

Ongoing Clinical Trials on ZOREVUNERSEN SODIUM

  • Study of zorevunersen to reduce seizures in patients with Dravet syndrome

    Recruiting

    3 1 1
    Investigated drugs:
    France Germany Italy Poland Spain Sweden

Glossary

  • Dravet syndrome: A rare and serious seizure disorder that begins early in life and can be difficult to control.
  • Phase 3: A late stage of clinical research that checks whether a treatment works and continues to study safety in a larger group of people.
  • Interventional study: A study where researchers give a treatment and watch what happens.
  • Double-blind: A study design where neither the participants nor the study team know who is getting the active treatment or the comparison treatment.
  • Sham: A fake or inactive comparison treatment used to help show whether the study drug has a real effect.
  • Safety: How well a treatment is tolerated and whether it causes harmful effects.
  • Tolerability: How easy a treatment is for patients to take or receive without too much discomfort or trouble.
  • Efficacy: How well a treatment works to produce the expected benefit.
  • Major motor seizure: A seizure type that causes strong body movement, such as hemiclonic, focal with motor signs, focal to bilateral tonic-clonic, generalized tonic-clonic, tonic, tonic/atonic, or bilateral clonic seizures.
  • Intrathecal use: A way of giving treatment into the fluid around the spinal cord.
  • Baseline: The starting point before treatment begins, used for comparison later in the study.
  • Sham comparison: A comparison with a treatment that does not contain the active study drug, used to see if the real treatment makes a difference.

References