RecruitingPhase 3NCT06840496

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

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase 3 Study of Bionetide for the Treatment of Girls and Women With Rett Syndrome


Sponsor

Biomed Industries, Inc.

Enrollment

210 participants

Start Date

Sep 30, 2026

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Sex: FEMALEMin Age: 5 YearsMax Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Bionetide and a drug called Placebo for people with rett syndrome. The study is currently recruiting participants at 18 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBionetide

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

DRUGPlacebo

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


Locations(18)

Biomed Testing Facility # BIO-01-85012

Phoenix, Arizona, United States

Biomed Testing Facility # BIO-05-92093

La Jolla, California, United States

Biomed Testing Facility # BIO-04-90095

Los Angeles, California, United States

Biomed Testing Facility # BIO-03-95817

Sacramento, California, United States

Biomed Testing Facility # BIO-02-94104

San Francisco, California, United States

Biomed Testing Facility #BIO-06-80042

Aurora, Colorado, United States

Biomed Testing Facility #BIO-07-33606

Tampa, Florida, United States

Biomed Testing Facility #BIO-08-60612

Chicago, Illinois, United States

Maryland Locations Biomed Testing Facility #BIO-9-21205

Baltimore, Maryland, United States

Biomed Testing Facility #BIO-10-02115

Boston, Massachusetts, United States

Biomed Testing Facility #BIO-13-10467

The Bronx, New York, United States

Biomed Testing Facility #BIO-17-19104

Philadelphia, Pennsylvania, United States

Biomed Testing Facility #BIO-19-77030

Houston, Texas, United States

Biomed Testing Facility #BIO-20-98105

Seattle, Washington, United States

Biomed Research Unit-BIO-23-NSW 2050

Camperdown, New South Wales, Australia

Biomed Research Unit-BIO-24-NSW-4101

South Brisbane, Queensland, Australia

Biomed Research Unit-BIO-21-VIC-3084

Heidelberg West, Victoria, Australia

Biomed Research Unit- BIO-22-VIC 3010

Parkville, Victoria, Australia

View Full Details on ClinicalTrials.gov

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NCT06840496


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