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Trial of Brexpiprazole Once-weekly (QW) Formulation in Patients With Acute Schizophrenia

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 6 months later Feb 2026 → Sep 2027
See other at-risk trials from Astex Pharmaceuticals

Record History

  1. Primary completion pushed from Feb 2026 to Sep 2027 Completion pushed from Mar 2026 to Oct 2027 · Interventions: OPC-34712FUM/ Brexpiprazole fumarate (Drug), Placebo (Drug) to OPC-34712FUM/ Brexpiprazole fumarate (Drug), Placebo (Drug) · Eligibility criteria expanded, about 25 words · 1 more Show 4 more changesShow less
    • Completion pushed from Mar 2026 to Oct 2027
    • Interventions: OPC-34712FUM/ Brexpiprazole fumarate (Drug), Placebo (Drug) to OPC-34712FUM/ Brexpiprazole fumarate (Drug), Placebo (Drug)
    • Eligibility criteria expanded, about 25 words
    • Collaborators: details revised at 1 of 1 entry
  2. Start date: Jun 21, 2022 to Jul 21, 2022v7
  3. Primary completion date: Apr 2025 to Feb 2026 Completion date: May 2025 to Mar 2026v6 Show 1 more changeShow less
    • Completion date: May 2025 to Mar 2026
  4. Eligibility criteria shortened, about 114 wordsv5 See this version in full on ClinicalTrials.gov ↗
  5. Eligibility criteria expanded, about 61 wordsv4 See this version in full on ClinicalTrials.gov ↗
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  1. Enrollment target: 550 to 450 Start date: Jul 21, 2022 to Jun 21, 2022 · Eligibility criteria expanded, about 29 wordsv3 Show 2 more changesShow less
    • Start date: Jul 21, 2022 to Jun 21, 2022
    • Eligibility criteria expanded, about 29 words

    See this version in full on ClinicalTrials.gov ↗

  2. Start date changed from estimate of Apr 2022 to Jul 21, 2022v2
  1. Study 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Confirm the efficacy of the brexpiprazole QW formulation versus placebo for acute symptoms of schizophrenia
Trial Details
NCT Number NCT05325645
Lead Sponsor Otsuka Pharmaceutical Co., Ltd.
Collaborators: Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions Acute Schizophrenia
Enrollment 450 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov