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NCT06840496 · ClinicalTrials.gov registry record · Phase 3
To Investigate the Efficacy of Treatment With Oral NA-921 (Bionetide) Versus Placebo in Females With Rett Syndrome
A Phase 3 study of Rett Syndrome, sponsored by Biomed Industries.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 210
- Enrollment target
- 20
- Study locations
NCT06840496: Recruiting Phase 3 study of Rett Syndrome, sponsored by Biomed Industries.
NCT06840496 is a Phase 3 study of Rett Syndrome that is actively recruiting participants, run by Biomed Industries. The registered enrollment target is 210 participants, below the 514-participant average among 18 other Rett Syndrome trials with a reported enrollment target (59% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06840496, a Phase 3 study of Rett Syndrome, is actively recruiting participants, sponsored by Biomed Industries.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 210 participants
- Enrollment target
- 20
- Study locations
Study 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
Primary Outcome
The RSBQ is a 45-item caregiver-completed rating scale that includes 45 items, 39 of them grouped into 8 subscales, whose ratings reflect the severity and frequency of symptoms. Items are rated as 0 (not true), 1 (somewhat or sometimes true), or 2 (very true). The 8 subscales are general mood, breathing problems, hand behavior, face movements, body rocking/expressionless face, night-time behaviors, fear/anxiety, and walking/standing. Scores for item 31 are reversed in the calculation of the tota
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Bionetide
Study Locations (20)
California
- Biomed Testing Facility # BIO-05-92093 - La Jolla
- Biomed Testing Facility # BIO-04-90095 - Los Angeles
- Biomed Testing Facility # BIO-03-95817 - Sacramento
- Biomed Testing Facility # BIO-02-94104 - San Francisco
Ohio
- Biomed Testing Facility #BIO-15-45229 - Cincinnati
- Biomed Testing Facility #BIO-16-44195 - Cleveland
Arizona
- Biomed Testing Facility # BIO-01-85012 - Phoenix
Colorado
- Biomed Testing Facility #BIO-06-80042 - Aurora
Florida
- Biomed Testing Facility #BIO-07-33606 - Tampa
Illinois
- Biomed Testing Facility #BIO-08-60612 - Chicago
Maryland
- Maryland Locations Biomed Testing Facility #BIO-9-21205 - Baltimore
Massachusetts
- Biomed Testing Facility #BIO-10-02115 - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 210 participants |
| Start Date | 2025-10-30 |
| Est. Completion | 2026-11-30 |
| Phase | Phase 3 |
What NCT06840496 shows while recruiting
NCT06840496 is an interventional study that assigns participants to a tested intervention. The registered 210 participants enrollment target is mid-sized for trials with a published cap, below the 514-participant average among 18 other Rett Syndrome trials with a reported enrollment target (59% lower).
The record links to 1 condition, with Rett Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06840496 names 20 study sites across 16 states, led by California, Ohio, Arizona.
Frequently Asked Questions
What is clinical trial NCT06840496 about?
NCT06840496 is a clinical study titled "To Investigate the Efficacy of Treatment With Oral NA-921 (Bionetide) Versus Placebo in Females With Rett Syndrome". 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 syndrom...
What is the current status of trial NCT06840496?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 210 participants. The study started on 2025-10-30. Estimated completion is 2026-11-30.
What conditions does trial NCT06840496 study?
This clinical trial studies the following conditions: Rett Syndrome.
What interventions are being tested in trial NCT06840496?
The interventions under investigation include: Placebo (DRUG), Bionetide (DRUG).
Who is sponsoring clinical trial NCT06840496?
This trial is sponsored by Biomed Industries, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06840496 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06840496's enrollment target sits among peer trials
210 4th of 18 higher than 15 of 18 other Rett Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Rett Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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