drugset / Trial / NCT07093541

Expanded Access Program for Treatment With Ecopipam for Tourette's Disorder

NCT07093541

Expanded access Available Emalex Biosciences Inc.

Summary

The goal of this expanded access study is to learn about the long-term effects of Ecopipam in participants with Tourette's Disorder (TD). The main question it aims to answer is: * Is ecopipam safe and well-tolerated in participants equal and over the age of 6 to 50 with TD? * Assess quality of life measures and to provide access to ecopipam while NDA is being prepared and submitted for review for marketing approval Eligible participants with TD will take ecopipam with guidance from their treating physician. In addition to the standard of care from the treating physician, treatment with ecopipam will continue until ecopipam becomes commercially available in the United States or the program is terminated. While in the EAP program, participants will be asked regarding how safe and tolerable ecopipam is to the participant. Several questionnaires will be collected regarding participants experiences while taking ecopipam during monthly visits for the first year and every three months thereafter until the conclusion of the study.

Timeline

Start
Primary completion
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Ecopipam Small molecule 2 mg/kg Oral

Indications