TrialA Phase 1/2/3 Study of TSHA-102 Gene Therapy in Females With Rett Syndrome (REVEAL Pivotal Study)
Trial details
- Registry ID
- NCT05606614
- Phase
- Phase 3
TSHA
Taysha Gene Therapies, Inc.
Company identity checked against sources
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2Trials in this database
11Recorded changes · last 12 months
Partial coverageOnly the trials and history collected so far
Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.
Completion dates · Pro
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Included trials
Check company identity source| Trial | Sponsor | Phase | Status | Primary completion |
|---|---|---|---|---|
| A Phase 1/2/3 Study of TSHA-102 Gene Therapy in Females With Rett Syndrome (REVEAL Pivotal Study)NCT05606614 | TSHA | Phase 3 | Active not recruiting | 2031-06Estimated |
| Safety and Preliminary Efficacy of TSHA-102 Gene Therapy in Pediatric Females Aged >2 to <4 Years With Rett SyndromeNCT07480564 | TSHA | Phase 3 | Active not recruiting | 2031-06Estimated |
Safety and Preliminary Efficacy of TSHA-102 Gene Therapy in Pediatric Females Aged >2 to <4 Years With Rett Syndrome
Trial details
- Registry ID
- NCT07480564
- Phase
- Phase 3
Latest recorded trial changes
Safety and Preliminary Efficacy of TSHA-102 Gene Therapy in Pediatric Females Aged >2 to <4 Years With Rett Syndrome
NCT07480564 · Taysha Gene Therapies, Inc.
Participant count type changed
− Before
Estimated
+ After
Actual
Enrollment · participant count changed
− Before
3 participants (planned)
+ After
4 participants (actual)
Recruitment status changed
− Before
Recruiting
+ After
Active not recruiting
A Phase 1/2/3 Study of TSHA-102 Gene Therapy in Females With Rett Syndrome (REVEAL Pivotal Study)
NCT05606614 · Taysha Gene Therapies, Inc.
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
Safety and Preliminary Efficacy of TSHA-102 Gene Therapy in Pediatric Females Aged >2 to <4 Years With Rett Syndrome
NCT07480564 · Taysha Gene Therapies, Inc.
Recruitment status changed
− Before
Not yet recruiting
+ After
Recruiting
A Phase 1/2/3 Study of TSHA-102 Gene Therapy in Females With Rett Syndrome (REVEAL Pivotal Study)
NCT05606614 · Taysha Gene Therapies, Inc.
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