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NCT05606614 · ClinicalTrials.gov registry record · Phase 3
A Phase 1/2/3 Study of TSHA-102 Gene Therapy in Females With Rett Syndrome (REVEAL Pivotal Study)
A Phase 3 study of Rett Syndrome, sponsored by Taysha Gene Therapies.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 15
- Enrollment target
- 6
- Study locations
NCT05606614: Recruiting Phase 3 study of Rett Syndrome, sponsored by Taysha Gene Therapies.
NCT05606614 is a Phase 3 study of Rett Syndrome that is actively recruiting participants, run by Taysha Gene Therapies. The registered enrollment target is 15 participants, below the 525-participant average among 18 other Rett Syndrome trials with a reported enrollment target (97% lower). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05606614, a Phase 3 study of Rett Syndrome, is actively recruiting participants, sponsored by Taysha Gene Therapies.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 15 participants
- Enrollment target
- 6
- Study locations
Study Summary
The primary objectives of this study are to evaluate the safety of a single intrathecal (IT) dose of TSHA-102 in females with typical Rett syndrome, to select the TSHA-102 dose with the best benefit/risk profile based on the totality of safety and efficacy data and to evaluate the efficacy and safety of TSHA-102 at the selected dose.
Primary Outcome
Proportions of participants experiencing any treatment-emergent adverse events (AEs) and serious adverse events (SAEs)
Conditions Studied
Interventions
- GENETIC TSHA-102
Study Locations (6)
California
- UC San Diego - La Jolla
Illinois
- Rush University Medical Center - Chicago
Massachusetts
- Boston Children's Hospital - Boston
Missouri
- Washington University, St. Louis - St Louis
Texas
- UT Southwestern Children's Medical Center - Dallas
Quebec
- CHU St. Justine - Montreal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2023-03-06 |
| Est. Completion | 2031-06 |
| Phase | Phase 3 |
What NCT05606614 shows while recruiting
NCT05606614 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 525-participant average among 18 other Rett Syndrome trials with a reported enrollment target (97% 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.
NCT05606614 lists 6 locations in 6 states (California, Illinois, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT05606614 about?
NCT05606614 is a clinical study titled "A Phase 1/2/3 Study of TSHA-102 Gene Therapy in Females With Rett Syndrome (REVEAL Pivotal Study)". The primary objectives of this study are to evaluate the safety of a single intrathecal (IT) dose of TSHA-102 in females with typical Rett syndrome, to select the TSHA-102 dose with the best benefit/risk profile based on the totality of safety and efficacy data and to evaluate the efficacy and safet...
What is the current status of trial NCT05606614?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 15 participants. The study started on 2023-03-06. Estimated completion is 2031-06.
What conditions does trial NCT05606614 study?
This clinical trial studies the following conditions: Rett Syndrome.
What interventions are being tested in trial NCT05606614?
The interventions under investigation include: TSHA-102 (GENETIC).
Who is sponsoring clinical trial NCT05606614?
This trial is sponsored by Taysha Gene Therapies, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05606614 being conducted?
This trial has 6 study locations across California, Illinois, Massachusetts, Missouri, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05606614's enrollment target sits among peer trials
15 15th of 18 higher than 4 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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