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To Investigate the Efficacy of Treatment With Oral NA-921 (Bionetide) Versus Placebo in Females With Rett Syndrome

StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Primary completion date: Aug 30, 2026 to Sep 30, 2027v3 Show 4 more changesShow less
    • Start date: Oct 30, 2025 to Sep 30, 2026
    • Study sites: 24 to 18
    • Study completion date: Nov 30, 2026 to Dec 30, 2027
    • Collaborators expanded, about 2 words
  2. Primary completion date: Nov 15, 2025 to Aug 30, 2026
    • Start date: Jun 15, 2025 to Oct 30, 2025
    • Study completion date: Mar 15, 2026 to Nov 30, 2026
    v2
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Primary Objective • To investigate the efficacy of treatment with oral Bionetide versus placebo in girls and women with Rett syndrome Key Secondary Objective • To investigate the efficacy of treatment with oral Bionetide versus placebo on ability to communicate in girls and women with Rett syndrome
Trial Details
NCT Number NCT06840496
Lead Sponsor Biomed Industries, Inc.
Collaborators: Bioneurals Ltd
Conditions
(from sponsor)		 Rett Syndrome
Related terms Genetic Diseases, X-Linked, Rett Syndrome
Enrollment 210 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov