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EMPEROR: A Multicenter, Randomized, Double-blind, Sham-controlled, Parallel Group, Phase 3 Study Evaluating the Efficacy, Safety, and Tolerability of Zorevunersen (STK-001) in Patients with Dravet Syndrome

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-519555-28-00
Acronym
STK-001-DS-301
Enrollment
56
Registered
2025-06-30
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-08

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

Conditions

Dravet syndrome

Brief summary

Percent change from baseline in major motor seizure frequency (number per 28 days) in patients receiving zorevunersen as compared with sham from Week 16 to Week 28.

Detailed description

Percent change from baseline in major motor seizure frequency (number per 28 days) in patients receiving zorevunersen as compared with sham from Week 16 to Week 52., Change from baseline on a multi-component Vineland-3 Outcome Score in patients receiving zorevunersen as compared with sham at Week 52., Change from baseline in subdomain scores on the Vineland-3 in patients receiving zorevunersen as compared with sham at Week 52.

Interventions

DRUGSTK-001

Sponsors

Stoke Therapeutics Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
Percent change from baseline in major motor seizure frequency (number per 28 days) in patients receiving zorevunersen as compared with sham from Week 16 to Week 28.

Secondary

MeasureTime frame
Percent change from baseline in major motor seizure frequency (number per 28 days) in patients receiving zorevunersen as compared with sham from Week 16 to Week 52., Change from baseline on a multi-component Vineland-3 Outcome Score in patients receiving zorevunersen as compared with sham at Week 52., Change from baseline in subdomain scores on the Vineland-3 in patients receiving zorevunersen as compared with sham at Week 52.

Countries

France, Germany, Italy, Poland, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026