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A Study to Explore the Effect of Sepranolone in Tourette Syndrome

A

Asarina Pharma

Status and phase

Completed
Phase 2

Conditions

Tourette Syndrome
Tourette Syndrome in Adolescence

Treatments

Drug: Sepranolone

Study type

Interventional

Funder types

Other
Industry

Identifiers

Details and patient eligibility

About

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

Enrollment

26 patients

Sex

All

Ages

12 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

26 participants in 2 patient groups

Sepranolone
Experimental group
Description:
Sepranolone 10 mg sc twice weekly for 12 weeks alongside the patient's standard of care Tourette treatment.
Treatment:
Drug: Sepranolone
No Intervention
No Intervention group
Description:
Continuation of the patient's standard of care Tourette treatment for 12 weeks.

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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