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โ† Trials
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A Clinical Trial of Elsunersen in Pediatric SCN2A-DEE to Assess Efficacy and Safety

RecruitingPhase 3Ages 1 Day - 18 YearsAllPraxis Precision Medicines
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In plain words

What the trial is, and whether it could suit you

A Multi-Center, Single-Arm Clinical Trial to Investigate the Efficacy and Safety of Elsunersen in Pediatric Participants with Early Onset SCN2A Developmental and Epileptic Encephalopathy

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Has a documented Gain of Function SCN2A variant confirmed through genetic testing. * Has onset of seizures prior to 3 months of age. * Seizure frequency of 4 or more countable motor seizures per 28-day during the Baseline Observation Period. Exclusion Criteria: * Has any clinically significant or known pathogenic genetic variant other than in the SCN2A gene, or a genetic variant that may explain or contribute to the participant's epilepsy and/or developmental disorder. * Has bone, spine (eg, kyphosis, scoliosis), bleeding, or other disorder. * Has received any experimental or investigational drug, device, or other therapy within 30 days or 5 half-lives (whichever is longer) prior to Screening, including any prior use of gene therapy. * Is currently pregnant or breastfeeding or is planning to become pregnant during the clinical trial.
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What it tests

  • 1mg elsunersen
  • 0.5mg elsunersen
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Where

10 sites
Praxis Research Site
San Diego, United States
Praxis Research Site
Aurora, United States
Praxis Research Site
Chicago, United States
Praxis Research Site
Cincinnati, United States
Praxis Research Site
Philadelphia, United States
Praxis Research Site
Memphis, United States
Praxis Research Site
Porto Alegre, Brazil
Praxis Research Site
Sรฃo Paulo, Brazil

โ€ฆand 2 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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