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

NCT06840496 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2026-03-27

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

Bionetide

Bionetide solution of 20-40 mL based on the subject's weight at Baseline, administered twice daily by mouth or gastrostomy tube (G-tube)

DRUG

Placebo

Placebo • Bionetide placebo solution administered based on the subject's weight at Baseline, twice daily for 12 weeks

Sponsors & Collaborators

  • Bioneurals Ltd

    collaborator UNKNOWN

  • Biomed Industries, Inc.

    lead INDUSTRY

Principal Investigators

  • Lloyd L Tran, PhD · Biomed Industries, Inc.

  • David Nguyen, PhD · Biomed Industries, Inc.

  • Zung V Tran, PhD · Biomed Industries, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
20 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2027-09-30
Completion
2027-12-30
FDA Drug
Yes

Countries

  • United States
  • Australia

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06840496 on ClinicalTrials.gov