Status:
COMPLETED
A Study to Explore the Effect of Sepranolone in Tourette Syndrome
Lead Sponsor:
Asarina Pharma
Conditions:
Tourette Syndrome
Tourette Syndrome in Adolescence
Eligibility:
All Genders
12-55 years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- Tic severity score ≥ 20 Yale Global Tic Severity Scale (YGTSS) Total Score at baseline
- The patient may have Obsessive-Compulsive Disease (OCD) as a comorbidity
Exclusion
- Patient has participated in a clinical study over the past 30 days
- Evidence or history of neurological disease that may interfere with the study
- Malignant disease
- Unstable or clinical significant medical condition that could pose a risk
- HIV/ongoing hepatitis
- Clinical significant findings in vital signs
- History of anaphylactic reactions
Key Trial Info
Start Date :
February 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2023
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT05434546
Start Date
February 16 2022
End Date
February 1 2023
Last Update
June 9 2023
Active Locations (2)
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1
Herlev Hospital
Copenhagen, Herlev, Denmark, 2730
2
Bispebjerg Hospital
Copenhagen, Denmark, 2400