Clinical trials / NCT05606614
NCT05606614Phase 3Active not recruiting

A Phase 1/2/3 Study of TSHA-102 Gene Therapy in Females With Rett Syndrome (REVEAL Pivotal Study)

Study sponsor: Taysha Gene Therapies, Inc. · TSHA

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2031-06Estimated
Enrollment · participants17Actual
Source updated2026-07-07Last update listed in the registry record
Version history

Changes to this trial

Last 12 months
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· 3 fields changed

Participant count type changed

− Before

Estimated

+ After

Actual

Enrollment · participant count changed

− Before

15 participants (planned)

+ After

17 participants (actual)

Recruitment status changed

− Before

Recruiting

+ After

Active not recruiting

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· 4 fields changed

Main study measure wording changed

Text changed; whether the study measures changed has not been verified. Saved text may be shortened.

Compare wording
− Before

Measure: Proportions of participants experiencing any treatment-emergent adverse events (AEs) and serious adverse events (SAEs) Measure: Change from baseline in participant's status after TSHA-102 administration as assessed by Clinical Global Impressions-Improvement (CGI-I) scale, adapted to Rett syndrome Measure: Change from baseline in participant's status after TSHA-102 administration as assessed by the Revised Motor Behavior Assessment (R-MBA) Measure: Change from baseline in participant's status after TSHA-102 administration as assessed by the Rett Syndrome Hand Function Scale (RSHFS)

+ After

Measure: Part A: Safety and Tolerability of TSHA-102 Measure: Part B: Efficacy of TSHA-102

Planned enrollment decreased by 3 participants

− Before

18 participants (planned)

+ After

15 participants (planned)

Primary completion date changed

− Before

2 Nov 2028

+ After

Jun 2031

Phase changed

− Before

PHASE1, PHASE2

+ After

PHASE3

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