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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 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.

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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.

Conditions Studied

Rett Syndrome

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

FieldValue
Enrollment Target 15 participants
Start Date 2023-03-06
Est. Completion 2031-06
Phase Phase 3

Sponsor

Taysha Gene Therapies

3 total trials

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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, categorized as Phase 3. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 525-participant average among 18 other Rett Syndrome trials with a reported enrollment target (97% lower). The listed sponsor is Taysha Gene Therapies, which has 3 total studies on file at ClinicalTrials.gov.

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 reports 6 study locations spanning 6 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.