drugset / Trial / NCT05434546

A Study to Explore the Effect of Sepranolone in Tourette Syndrome

NCT05434546 ↗

Phase 2 Completed 26 enrolled Asarina Pharma
RandomizedParallel-groupOpen-labelTreatment

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

Timeline

Start
2022-02-16
Primary completion
2023-02-01
Completion
2023-02-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Sepranolone Small molecule 10 mg Subcutaneous

Indications