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NCT06152237 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy of TSHA-102 in Pediatric Females With Rett Syndrome (REVEAL Pediatric Study)
A Phase 1 study of Rett Syndrome, sponsored by Taysha Gene Therapies.
- Active
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
- 5
- Study locations
NCT06152237: Active Phase 1 study of Rett Syndrome, sponsored by Taysha Gene Therapies.
NCT06152237 is a Phase 1 study of Rett Syndrome that is active but no longer recruiting, run by Taysha Gene Therapies. The registered enrollment target is 6 participants, below the 526-participant average among 18 other Rett Syndrome trials with a reported enrollment target (99% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06152237, a Phase 1 study of Rett Syndrome, is active but no longer recruiting, sponsored by Taysha Gene Therapies.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
- 5
- Study locations
Study Summary
The REVEAL Pediatric Study is a multi-center, Phase 1/2 open-label, dose-escalation and dose-expansion study of TSHA-102, an investigational gene therapy, in pediatric females with Rett Syndrome. The safety, tolerability, and preliminary efficacy of two dose levels will be evaluated. The study duration is up to 6 years.
Primary Outcome
The incidence of participants experiencing any treatment-emergent adverse events (AEs) and serious adverse events (SAEs)
Conditions Studied
Interventions
- GENETIC TSHA-102
Study Locations (5)
Illinois
- Rush University Medical Center & Children's Hospital - Chicago
Minnesota
- Gillette Children's Specialty Healthcare - Saint Paul
Missouri
- Washington University, St. Louis - St Louis
Quebec
- CHU Ste-Justine - Montreal
Other
- Children's Neurosciences, Evelina London Children's Hospital, Guy's and St Thomas' NHS Foundation Trust - London
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2023-12-12 |
| Est. Completion | 2031-11-02 |
| Phase | Phase 1 |
What the registry record for NCT06152237 still lists
NCT06152237 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 526-participant average among 18 other Rett Syndrome trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Rett Syndrome appearing as the primary indexed condition, and to 1 intervention - of which TSHA-102 is the first listed.
NCT06152237 lists 5 locations in 5 states (Illinois, Minnesota, Missouri).
Frequently Asked Questions
What is clinical trial NCT06152237 about?
NCT06152237 is a clinical study titled "Safety and Efficacy of TSHA-102 in Pediatric Females With Rett Syndrome (REVEAL Pediatric Study)". The REVEAL Pediatric Study is a multi-center, Phase 1/2 open-label, dose-escalation and dose-expansion study of TSHA-102, an investigational gene therapy, in pediatric females with Rett Syndrome. The safety, tolerability, and preliminary efficacy of two dose levels will be evaluated. The study dura...
What is the current status of trial NCT06152237?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2023-12-12. Estimated completion is 2031-11-02.
What conditions does trial NCT06152237 study?
This clinical trial studies the following conditions: Rett Syndrome.
What interventions are being tested in trial NCT06152237?
The interventions under investigation include: TSHA-102 (GENETIC).
Who is sponsoring clinical trial NCT06152237?
This trial is sponsored by Taysha Gene Therapies, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06152237 being conducted?
This trial has 5 study locations across Illinois, Minnesota, Missouri, Quebec. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06152237's enrollment target sits among peer trials
6 19th of 18 the lowest 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.
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