A Clinical Study to Evaluate the Safety and Efficacy of T92 in Pediatric Patients With Tourette Syndrome

Tourette Syndrome in Adolescence Clinical Trial

Official title: A Multicenter, Randomized, Double-blind, and Placebo-controlled Clinical Study to Evaluate the Safety and Efficacy of T92 in Pediatric Patients With Tourette Syndrome

Status Not yet recruiting

Clinical Trial Summary

A 12-week clinical study to evaluate the safety and efficacy of T92 in pediatric patients with Tourette Syndrome.

Clinical Trial Description

This is a multi-center, randomized, double-blind, placebo-controlled, outpatient clinical study designed to evaluate the efficacy and safety of T92 in Tourette Syndrome pediatric patients.

This trial consists of a screening/wash-out period of up to 6 weeks, an 8-week supportive care period and a 4-week follow-up period for all subjects who completed the study. For the first two weeks, the patients will continue to take T92 at half dose and the T92 administration will be stopped from week 3 of the follow-up period.

Subjects will be randomly assigned to receive T92 or matching placebo based on individual body weight. The calculated amount of investigational product (T92 or placebo) will be administrated orally twice daily. Morning dose and evening dose should be administrated at about the same time every day and irrelevant to meals. ;

Related Conditions & MeSH terms

• Syndrome
• Tourette Syndrome
• Tourette Syndrome in Adolescence
• Tourette Syndrome in Children

• NCT number: NCT05188274
• Study type: Interventional
• Source: Tasly Pharmaceuticals, Inc.
• Contact: Michael H Bloch, MD, PhD
• Phone: 203-974-7551
• Email: michael.bloch@yale.edu
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2022
• Completion date: October 2024