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

PHASE3RecruitingINTERVENTIONAL
Enrollment

210

Participants

Timeline

Start Date

October 30, 2025

Primary Completion Date

August 30, 2026

Study Completion Date

November 30, 2026

Conditions
Rett Syndrome
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"

Trial Locations (24)

2050

RECRUITING

Biomed Research Unit-BIO-23-NSW 2050, Camperdown

3010

RECRUITING

Biomed Research Unit- BIO-22-VIC 3010, Parkville

3084

RECRUITING

Biomed Research Unit-BIO-21-VIC-3084, Heidelberg West

4101

RECRUITING

Biomed Research Unit-BIO-24-NSW-4101, South Brisbane

10467

RECRUITING

Biomed Testing Facility #BIO-13-10467, The Bronx

19104

RECRUITING

Biomed Testing Facility #BIO-17-19104, Philadelphia

21205

RECRUITING

Maryland Locations Biomed Testing Facility #BIO-9-21205, Baltimore

27599

RECRUITING

Biomed Testing Facility #BIO-14-27599, Chapel Hill

33606

RECRUITING

Biomed Testing Facility #BIO-07-33606, Tampa

37232

RECRUITING

Biomed Testing Facility #BIO-18-37232, Nashville

44195

RECRUITING

Biomed Testing Facility #BIO-16-44195, Cleveland

45229

RECRUITING

Biomed Testing Facility #BIO-15-45229, Cincinnati

55101

RECRUITING

Minnesota Locations Biomed Testing Facility #BIO-11-55101, Saint Paul

60612

RECRUITING

Biomed Testing Facility #BIO-08-60612, Chicago

63110

RECRUITING

Missouri Locations Biomed Testing Facility #BIO-12-63110, St Louis

77030

RECRUITING

Biomed Testing Facility #BIO-19-77030, Houston

80042

RECRUITING

Biomed Testing Facility #BIO-06-80042, Aurora

85012

RECRUITING

Biomed Testing Facility # BIO-01-85012, Phoenix

90045

RECRUITING

Biomed Testing Facility # BIO-04-90095, Los Angeles

92093

RECRUITING

Biomed Testing Facility # BIO-05-92093, La Jolla

94104

RECRUITING

Biomed Testing Facility # BIO-02-94104, San Francisco

95817

RECRUITING

Biomed Testing Facility # BIO-03-95817, Sacramento

98105

RECRUITING

Biomed Testing Facility #BIO-20-98105, Seattle

02115

RECRUITING

Biomed Testing Facility #BIO-10-02115, Boston

All Listed Sponsors
lead

Biomed Industries, Inc.

INDUSTRY

NCT06840496 - To Investigate the Efficacy of Treatment With Oral NA-921 (Bionetide) Versus Placebo in Females With Rett Syndrome | Biotech Hunter | Biotech Hunter