A Study to Explore the Effect of Sepranolone in Tourette Syndrome

Status Completed

Clinical Trial Summary

The study was an open-label, randomized, multicenter, parallel, Phase 2a study in adolescents and adult patients with Tourette syndrome that aimed to explore the efficacy of Sepranolone as a treatment for Tourette syndrome, by reducing the severity and frequency of tics. The total study duration from the Screening Visit to the final follow-up visit was approximately 26 weeks and included the following periods: - A baseline period of 4 weeks between the screening visit (Visit 1) and randomization (4 weeks of baseline period were not needed in well-known adult subjects with stable Tourette syndrome history over the past at least 4 weeks). A school holiday/annual leave period of 2-6 weeks where no study-related activities were done. - A randomized treatment period of 12 weeks - A safety follow-up period of 4 weeks

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05434546
Study type	Interventional
Source	Asarina Pharma
Contact
Status	Completed
Phase	Phase 2
Start date	February 16, 2022
Completion date	February 1, 2023

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