3 Participants NeededMy employer runs this trial

TSHA-102 Gene Therapy for Rett Syndrome

(ASPIRE Trial)

TG
Overseen ByTaysha Gene Therapies Medical Information
Age: < 18
Sex: Female
Trial Phase: Phase 3
Sponsor: Taysha Gene Therapies, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The primary objectives of this study are to evaluate the safety, tolerability and preliminary efficacy of a single intrathecal (IT) dose of TSHA-102 in pediatric females with typical Rett syndrome.

Who Is on the Research Team?

MM

Medical Monitor, M.D.

Principal Investigator

Taysha Gene Therapies

Are You a Good Fit for This Trial?

This trial is for girls aged 2 to under 4 years old who have been diagnosed with classic Rett syndrome caused by a specific gene mutation. Participants must be able to stay near the study site and agree to receive blood products if needed.

Inclusion Criteria

I have classic Rett syndrome with a confirmed MECP2 gene mutation causing loss of function.
I am willing to receive blood transfusions if needed.
* Participants and parent/caregiver must agree to reside within easy access to the study site prior to the baseline visit and at least 3 months after TSHA-102 treatment.
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What Are the Treatments Tested in This Trial?

Interventions

  • TSHA-102

Trial Overview

The study is testing a single dose of TSHA-102, a gene therapy given directly into the spinal fluid, to see if it is safe and shows early signs of helping young girls with Rett syndrome.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Taysha Gene Therapies, Inc.

Lead Sponsor

Trials
5
Recruited
60+