To Investigate the Efficacy of Treatment With Oral NA-921 (Bionetide) Versus Placebo in Females With Rett Syndrome
Biomed Industries, Inc. · with Bioneurals Ltd · NCT06840496
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 5–20 · Women only
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 3
- Target enrollment
- 210
- US sites recruiting
- 14
- Study start
- September 30, 2026
- Record last updated
- March 27, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study 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
Being studied: Bionetide; Placebo
Conditions: Rett Syndrome
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
INCLUSION CRITERIA
- Female subjects 5 to 20 years of age, inclusive, at Screening
- Body weight ≥12 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
EXCLUSION CRITERIA
- 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
Recruiting US locations
Biomed Testing Facility # BIO-01-85012
Phoenix, AZ 85012
Site contact: Jennifer Thompson, MS · 8008245135 · research@biomedind.com
Biomed Testing Facility # BIO-05-92093
La Jolla, CA 92093
Site contact: Jennifer Thompson · 8008245135 · research@biomedind.com
Biomed Testing Facility # BIO-04-90095
Los Angeles, CA 90045
Site contact: Jennifer Thompson, MS · 8008245135 · research@biomedind.com
Biomed Testing Facility # BIO-03-95817
Sacramento, CA 95817
Site contact: Jennifer Thompson, MS · 8008145135 · research@biomedind.com
Biomed Testing Facility # BIO-02-94104
San Francisco, CA 94104
Site contact: Jennifer Thompson, MS · 8008245135 · research@biomedind.com
Biomed Testing Facility #BIO-06-80042
Aurora, CO 80042
Site contact: Jennifer Thompson, MS · 8008245135 · research@biomedind.com
Biomed Testing Facility #BIO-07-33606
Tampa, FL 33606
Site contact: Jennifer Thompson, MS · 8008245135 · research@biomedind.com
Biomed Testing Facility #BIO-08-60612
Chicago, IL 60612
Site contact: Jennifer Thompson, MS · 8008245135 · research@biomedind.com
Maryland Locations Biomed Testing Facility #BIO-9-21205
Baltimore, MD 21205
Site contact: Jennifer Thompson, MS · 8008245135 · research@biomedind.com
Biomed Testing Facility #BIO-10-02115
Boston, MA 02115
Site contact: Jennifer Thompson, MS · 8008245135 · research@biomedind.com
Biomed Testing Facility #BIO-13-10467
The Bronx, NY 10467
Site contact: Jennifer Thompson, MS · 8008245135 · research@biomedind.com
Biomed Testing Facility #BIO-17-19104
Philadelphia, PA 19104
Site contact: Jennifer Thompson, MS · 8008245135 · research@biomedind.com
Biomed Testing Facility #BIO-19-77030
Houston, TX 77030
Site contact: Jennifer Thompson, MS · 8008245135 · research@biomedind.com
Biomed Testing Facility #BIO-20-98105
Seattle, WA 98105
Site contact: Jennifer Thompson, MS · 8008245135 · research@biomedind.com
Study contacts (from the official record)
- David L Nguyen, PhD · 1-800-824-5135 · research@biomedind.com
- Jennifer Thomposn, MS · 1-800-824-5135 · research@biomedind.com