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Sepranolone in Tourette Syndrome
NCT05434546Phase 2
Key facts
- Status
- Completed
- Start
- Feb 2022
- Primary completion
- Feb 2023
- Countries
- 1
- Sponsor
- Asarina Pharma AB
- Modality
- Allosteric Modulators
- Drugs
- sepranolone
- Conditions
- Tourette syndrome (TS)
01
Overview
Phase 2, randomised, open-label trial of sepranolone in Tourette syndrome (TS) (2 arms), sponsored by Asarina Pharma AB. Primary endpoint: Yale Global Tic Severity Scale Total Score at 12 weeks. Started Feb 2022; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Sepranolone
Sepranolone 10 mg sc twice weekly + SoC
No Intervention
Standard of Care only
03
Who it enrols
Adolescents and adults (12-47 years) with Tourette Syndrome and a YGTSS score >= 20. Patients with OCD are included. Patients with recent clinical trial participation, neurological disease, malignancy, or unstable medical conditions are excluded.
04
Endpoints
Primary
Yale Global Tic Severity Scale Total Score
Secondary
Safety and Tolerability
Yale Global Tic Severity Scale Impairment Score
Premonitory Urge for Tics Scale
Gilles de la Tourette Syndrome-Quality of Life Activities of Daily Living subscale
Tourette Syndrome-Clinical Global Impression
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