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MinorEligibility criteria expanded, about 24 words
Study sites revised (116)
MinorEnrollment increased: 292 → 367 participants
Study sites revised (116)
v21
MinorTrial status changed: Recruiting → Active, Not Recruiting
Enrollment target: estimated 320 to confirmed 292
Study sites: 114 to 116
v20
MinorTrial sites expanded: 110 → 114 locationsv19
MinorStudy sites: 109 to 110v18
MinorTrial sites expanded: 106 → 109 locationsv17
MinorStudy sites: 101 to 106v16
MinorStudy sites: 95 to 101
Eligibility criteria revised
v15
MinorRe-verified, no change to tracked fieldsv14
MinorStudy sites: 80 to 95v13
MinorStudy sites: 72 to 80v12
MinorStudy sites: 57 to 72v11
MinorStudy sites: 40 to 57v10
MinorStudy sites: 22 to 40v9
MinorStudy sites: 99 to 22
Primary completion date: Oct 2026 to Oct 31, 2026
Study completion date: Nov 2026 to Nov 30, 2026
v8
MinorSite details revised at 6 of 99 sitesv7
MinorSite details revised at 1 of 99 sitesv6
MinorSite details revised at 2 of 99 sitesv5
MinorStudy sites revised (99)v4
MinorStudy sites: 33 to 99v3
MinorStudy sites: 7 to 33v2
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This (DEEp OCEAN Study) is a double-blind, randomized, placebo-controlled, multicenter study to investigate the efficacy, safety, and tolerability of LP352 in the treatment of seizures in children and adults with DEE. The study consists of 3 main phases: Screening, Titration period, Maintenance period, followed by a Taper period and Follow-Up. The total duration of the study will be approximately 24 months.