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To Study the Efficacy & Safety of Oral NA-921 (Bionetide) in Girls and Women with Rett Syndrome

NCT06849973 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 187

Last updated 2025-02-27

No results posted yet for this study

Summary

To study the efficacy \& safety of oral Bionetide versus placebo in girls and women with Rett syndrome

Conditions

Interventions

DRUG

Drug: Bionetide

NA-921 (Bionetide) solution administered based on the subject's weight at Baseline, twice daily for 12 weeks

DRUG

Placebo

NA-921 (Bionetide) placebo solution administered based on the subject's weight at Baseline, twice daily for 12 weeks

Sponsors & Collaborators

  • Biomed Industries, Inc.

    lead INDUSTRY

Principal Investigators

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

  • David Nguyen, 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
2024-03-15
Primary Completion
2024-11-22
Completion
2025-01-28
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 NCT06849973 on ClinicalTrials.gov