A Study to Explore the Effect of Sepranolone in Tourette Syndrome

• Status: Recruiting
• Trial end date: 2023-03-31
• Target enrollment: 0
• Participant gender: All

Summary

30 subjects aged 12 to 45 years of age diagnosed with Tourette Syndrome with a YGTSS score > 20 during 30 days of baseline observation to be randomized to

1. continued present stable treatment (10 subjects) or

2. continued present stable treatment plus 10 mg of Sepranolone injected s.c. twice weekly for 12 weeks (20 patients) followed by one month of observation

Primary objective: to investigate the efficacy of Sepranolone to reduce tic severity in patients with Tourette syndrome after 12 weeks

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asarina Pharma
• Collaborator: Herlev Hospital
• Treatments: Pregnanolone

Criteria

Inclusion Criteria:

• Tic severity score > 20 (YGTSS) at baseline

• The patient may have OCD as a comorbidity

• All patients to continue stable cognitive or medical treatment (> 3 months)

Exclusion Criteria:

• 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