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A Phase 1/2/3 Study of TSHA-102 Gene Therapy in Females With Rett Syndrome (REVEAL Pivotal Study)
NCT05606614 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05606614
The ClinicalTrials.gov registry entry for NCT05606614 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Taysha Gene Therapies, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05606614 reports 6 study locations spanning 6 distinct geographic areas — top geographies include California, Illinois, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05606614?
The interventions under investigation include: TSHA-102 (GENETIC). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05606614?
This trial is sponsored by Taysha Gene Therapies, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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