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Hope for rett syndrome: new drug trial targets behavior and communication

NCT ID NCT06840496

Symptom relief Sponsor: Biomed Industries, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests an oral medicine called bionetide in 210 girls and women with Rett syndrome, a rare genetic disorder. The goal is to see if bionetide improves behavior and communication compared to a placebo over 12 weeks. Participants must be 5 to 20 years old and have a confirmed MECP2 gene mutation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 210 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

5 to 20 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

INCLUSION CRITERIA 1. Female subjects 5 to 20 years of age, inclusive, at Screening 2. Body weight ≥12 kg at Screening 3. Can swallow the study medication provided as a liquid solution or can take it by gastrostomy tube 4. Has classic/typical Rett syndrome (RTT) 5. Has a documented disease-causing mutation in the MECP2 gene 6. Has a stable pattern of seizures, or has had no seizures, within 8 weeks of Screening 7. 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. 8. The subject's caregiver is English-speaking and has sufficient language skills to complete the caregiver assessments 9. 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 1. Has been treated with insulin within 12 weeks of Baseline 2. 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 3. Has a history of, or current, cerebrovascular disease or brain trauma 4. Has significant, uncorrected visual or uncorrected hearing impairment 5. Has a history of, or current, malignancy 6. Has a known history or symptoms of long QT syndrome

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Conditions

The condition(s) this trial relates to.

Rett syndrome X-linked disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Rett syndrome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    18 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

  • Contact

    Email: •••••@•••••

Locations

  • Biomed Research Unit- BIO-22-VIC 3010

    RECRUITING

    Parkville, Victoria, 3010, Australia

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

  • Biomed Research Unit-BIO-21-VIC-3084

    RECRUITING

    Heidelberg West, Victoria, 3084, Australia

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

  • Biomed Research Unit-BIO-23-NSW 2050

    RECRUITING

    Camperdown, New South Wales, 2050, Australia

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

  • Biomed Research Unit-BIO-24-NSW-4101

    RECRUITING

    South Brisbane, Queensland, 4101, Australia

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

  • Biomed Testing Facility # BIO-01-85012

    RECRUITING

    Phoenix, Arizona, 85012, United States

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

  • Biomed Testing Facility # BIO-02-94104

    RECRUITING

    San Francisco, California, 94104, United States

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

  • Biomed Testing Facility # BIO-03-95817

    RECRUITING

    Sacramento, California, 95817, United States

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

  • Biomed Testing Facility # BIO-04-90095

    RECRUITING

    Los Angeles, California, 90045, United States

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

  • Biomed Testing Facility # BIO-05-92093

    RECRUITING

    La Jolla, California, 92093, United States

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

  • Biomed Testing Facility #BIO-06-80042

    RECRUITING

    Aurora, Colorado, 80042, United States

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

  • Biomed Testing Facility #BIO-07-33606

    RECRUITING

    Tampa, Florida, 33606, United States

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

  • Biomed Testing Facility #BIO-08-60612

    RECRUITING

    Chicago, Illinois, 60612, United States

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

  • Biomed Testing Facility #BIO-10-02115

    RECRUITING

    Boston, Massachusetts, 02115, United States

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

  • Biomed Testing Facility #BIO-13-10467

    RECRUITING

    The Bronx, New York, 10467, United States

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

  • Biomed Testing Facility #BIO-17-19104

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

  • Biomed Testing Facility #BIO-19-77030

    RECRUITING

    Houston, Texas, 77030, United States

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

  • Biomed Testing Facility #BIO-20-98105

    RECRUITING

    Seattle, Washington, 98105, United States

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

  • Maryland Locations Biomed Testing Facility #BIO-9-21205

    RECRUITING

    Baltimore, Maryland, 21205, United States

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

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