A Study to Explore the Effect of Sepranolone in Tourette Syndrome
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sepranolone | Small molecule | 10 mg | Subcutaneous |