NCT05434546

A Study to Explore the Effect of Sepranolone in Tourette Syndrome

A Randomized, Open-label, Multicenter, Phase 2 Clinical Trial to Explore the Safety and Efficacy of Sepranolone in Pediatric and Adult Patients With Tourette Syndrome

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Asarina Pharma · Industry
• Sex: All
• Age: 12 Years – 55 Years
• Healthy volunteers: Not accepted

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

Conditions

• Tourette Syndrome
• Tourette Syndrome in Adolescence

Interventions

Type	Name	Description
DRUG	Sepranolone	Treatment with 10 mg Sepranolone s.c. twice weekly for 12 weeks alongside patient's standard of care Tourette treatment.

Timeline

• Start date: 2022-02-16
• Primary completion: 2023-02-01
• Completion: 2023-02-01
• First posted: 2022-06-28
• Last updated: 2023-06-09

Locations

2 sites across 1 country: Denmark