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Tests treatment safety and results for Dravet Syndrome
Official title A Double-blind Study Evaluating the Efficacy, Safety, and Tolerability of Zorevunersen in Patients With Dravet Syndrome
ClinicalTrials.gov ID: NCT06872125
What this study is testing
What is zorevunersen?
zorevunersen is an investigational medicine, being studied as a potential treatment for dravet syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of the study is to evaluate the efficacy, safety, and tolerability of zorevunersen in Patients with Dravet syndrome.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 17
You may be able to join if
- Patients must be ≥2 and \<18 years of age.
- Patients must have a clinical diagnosis of DS confirmed by the Epilepsy Study Consortium, Inc. (ESCI) and as defined by: Onset, prior to 12 months...
- Patient must have a documented pathogenic, likely pathogenic variant, or variant of uncertain significance in the sodium voltage-gated channel type 1...
- Patient must experience the required number of major motor seizures during the 6-week Observation Period. Major motor seizure types included are...
- Patient must have used at least 2 prior interventions for seizures. These can include anti-seizure medications (ASMs), ketogenic diet and/or vagus...
You likely can't join if
- Patient has documented variant in the SCN1A gene associated with gain-of-function
- Patient is currently treated with a maintenance ASM acting primarily as a sodium channel blocker, including but not limited to phenytoin...
- Patient is currently treated with neuromodulation techniques (e.g., responsive neurostimulation, deep brain stimulation, or transcranial magnetic...
- Patient has emergence of a new seizure type or reemergence of a past seizure type (seizure types that last occurred more than 12 months before...
See the full eligibility criteria
- Patients must be ≥2 and \<18 years of age.
- Patients must have a clinical diagnosis of DS confirmed by the Epilepsy Study Consortium, Inc. (ESCI) and as defined by: Onset, prior to 12 months (inclusive, \<13 months), of age, of recurrent focal with motor signs...
- Patient must have a documented pathogenic, likely pathogenic variant, or variant of uncertain significance in the sodium voltage-gated channel type 1 alpha subunit (SCN1A) gene. Patients who have SCN1A testing results...
- Patient must experience the required number of major motor seizures during the 6-week Observation Period. Major motor seizure types included are Seizure types included in counts are Hemiclonic, Focal with Motor Signs...
- Patient must have used at least 2 prior interventions for seizures. These can include anti-seizure medications (ASMs), ketogenic diet and/or vagus nerve stimulation (VNS) with either lack of adequate seizure control or...
- Patient must be taking at least one ASM. Benzodiazepines or ASMs used on a standing basis (i.e., not as needed [PRN]) for any indication will be considered an ASM.
- Patients' maintenance ASMs and interventions for seizures (i.e., ketogenic diet or VNS), as well as any marijuana- or cannabinoid-based products, must have been stable (unless adjusted for weight) during the Baseline...
- Patient has documented variant in the SCN1A gene associated with gain-of-function
- Patient is currently treated with a maintenance ASM acting primarily as a sodium channel blocker, including but not limited to phenytoin, carbamazepine, oxcarbazepine, lamotrigine, lacosamide, rufinamide, or cenobamate...
- Patient is currently treated with neuromodulation techniques (e.g., responsive neurostimulation, deep brain stimulation, or transcranial magnetic stimulation), with the exception of VNS.
- Patient has emergence of a new seizure type or reemergence of a past seizure type (seizure types that last occurred more than 12 months before Screening Visit A) during the Baseline Period, or has more than 1...
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Little Rock, Arkansas, United States
- Los Angeles, California, United States
- Orange, California, United States
- San Francisco, California, United States
- Aurora, Colorado, United States
- Washington D.C., District of Columbia, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Rochester, Minnesota, United States
- New York, New York, United States
- Rochester, New York, United States
- Chapel Hill, North Carolina, United States
- Durham, North Carolina, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
+ 33 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Little Rock, Arkansas, United States; Los Angeles, California, United States; Orange, California, United States; San Francisco, California, United States; Aurora, Colorado, United States and 47 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.