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ASCEND: Safety and Tolerability of ION337 for the Treatment of Dravet Syndrome

← catalyst calendar

NCT07531745 · readout ≤ 1,595 d

Sponsored by Ionis Pharmaceuticals, Inc. (industry) · IONS — their whole pipeline →.

Phase
Phase 1/2
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
32estimated
Sites
4
Country
United States

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2026-05-21actualWhen the study began enrolling
Primary completionDec 2030estimatedThe date the last participant is measured for the primary outcome — the readout window
Study completionDec 2030estimatedThe whole study's end, after follow-up
First posted2026-04-15actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2026-08-05actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

  • Dravet Syndrome

Intervention

  • Drug: ION337

Primary outcomes

what the primary-completion date above is the date OF
Parts 1 and 2: Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
measured Part 1: up to 6 months; Part 2: up to 31 months
Number of Participants With Clinically Significant Change From Baseline in Safety Laboratory Values
measured Part 1: up to 6 months; Part 2: up to 31 months
Parts 1 and 2: Number of Participants With Clinically Significant Change From Baseline in Vital Signs
measured Part 1: up to 6 months; Part 2: up to 31 months
Parts 1 and 2: Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG)
measured Part 1: up to 6 months; Part 2: up to 31 months
Parts 1 and 2: Number of Participants With Clinically Significant Change From Baseline in Physical and Neurological Examination Findings
measured Part 1: up to 6 months; Part 2: up to 31 months
Parts 1 and 2: Number of Participants with Change in Columbia Suicidality Severity Rating Scale (C-SSRS)
measured Part 1: up to 6 months; Part 2: up to 31 months

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