NCT05188274

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

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: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Tasly Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Tourette Syndrome in Children
• Tourette Syndrome in Adolescence

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	T92	T92 granules (5g/sachet) will be taken BID for 8 weeks, the dosage will be calculated by individual's body weight.
DIETARY_SUPPLEMENT	Placebo	The placebo matched to T92 granules will be taken BID for 8 weeks.

Timeline

• Start date: 2022-05-01
• Primary completion: 2024-02-01
• Completion: 2024-10-01
• First posted: 2022-01-12
• Last updated: 2022-01-12

Locations

1 site across 1 country: United States