Actively Recruiting
To Investigate the Efficacy of Treatment With Oral NA-921 (Bionetide) Versus Placebo in Females With Rett Syndrome
Led by Biomed Industries, Inc. · Updated on 2026-03-27
210
Participants Needed
18
Research Sites
65 weeks
Total Duration
On this page
Sponsors
B
Biomed Industries, Inc.
Lead Sponsor
B
Bioneurals Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
To Investigate the Efficacy of Treatment With Oral NA-921 (Bionetide) Versus Placebo in Females With Rett Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female subjects 5 to 20 years of age, inclusive, at Screening
- Body weight 6512 kg at Screening
- Can swallow the study medication provided as a liquid solution or can take it by gastrostomy tube
- Has classic/typical Rett syndrome (RTT)
- Has a documented disease-causing mutation in the MECP2 gene
- Has a stable pattern of seizures, or has had no seizures, within 8 weeks of Screening
- Subjects of childbearing potential must abstain from sexual activity for the duration of the study and for at least 30 days thereafter or must agree to use acceptable methods of contraception
- Subject must not be pregnant or breastfeeding
- The subject's caregiver is English-speaking and has sufficient language skills to complete the caregiver assessments
- Subject and caregiver(s) must reside at a location to which study drug can be delivered and have been at their present residence for at least 3 months prior to Screening
You will not qualify if you...
- Has been treated with insulin within 12 weeks of Baseline
- Has current clinically significant cardiovascular, endocrine (such as hypo- or hyperthyroidism, Type 1 diabetes mellitus, or uncontrolled Type 2 diabetes mellitus), renal, hepatic, respiratory or gastrointestinal disease (such as celiac disease or inflammatory bowel disease) or has major surgery planned during the study
- Has a history of, or current, cerebrovascular disease or brain trauma
- Has significant, uncorrected visual or uncorrected hearing impairment
- Has a history of, or current, malignancy
- Has a known history or symptoms of long QT syndrome
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 18 locations
1
Biomed Testing Facility # BIO-01-85012
Phoenix, Arizona, United States, 85012
Actively Recruiting
2
Biomed Testing Facility # BIO-05-92093
La Jolla, California, United States, 92093
Actively Recruiting
3
Biomed Testing Facility # BIO-04-90095
Los Angeles, California, United States, 90045
Actively Recruiting
4
Biomed Testing Facility # BIO-03-95817
Sacramento, California, United States, 95817
Actively Recruiting
5
Biomed Testing Facility # BIO-02-94104
San Francisco, California, United States, 94104
Actively Recruiting
6
Biomed Testing Facility #BIO-06-80042
Aurora, Colorado, United States, 80042
Actively Recruiting
7
Biomed Testing Facility #BIO-07-33606
Tampa, Florida, United States, 33606
Actively Recruiting
8
Biomed Testing Facility #BIO-08-60612
Chicago, Illinois, United States, 60612
Actively Recruiting
9
Maryland Locations Biomed Testing Facility #BIO-9-21205
Baltimore, Maryland, United States, 21205
Actively Recruiting
10
Biomed Testing Facility #BIO-10-02115
Boston, Massachusetts, United States, 02115
Actively Recruiting
11
Biomed Testing Facility #BIO-13-10467
The Bronx, New York, United States, 10467
Actively Recruiting
12
Biomed Testing Facility #BIO-17-19104
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
13
Biomed Testing Facility #BIO-19-77030
Houston, Texas, United States, 77030
Actively Recruiting
14
Biomed Testing Facility #BIO-20-98105
Seattle, Washington, United States, 98105
Actively Recruiting
15
Biomed Research Unit-BIO-23-NSW 2050
Camperdown, New South Wales, Australia, 2050
Actively Recruiting
16
Biomed Research Unit-BIO-24-NSW-4101
South Brisbane, Queensland, Australia, 4101
Actively Recruiting
17
Biomed Research Unit-BIO-21-VIC-3084
Heidelberg West, Victoria, Australia, 3084
Actively Recruiting
18
Biomed Research Unit- BIO-22-VIC 3010
Parkville, Victoria, Australia, 3010
Actively Recruiting
Research Team
D
David L Nguyen, PhD
CONTACT
J
Jennifer Thomposn, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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