NCT05434546

A Study to Explore the Effect of Sepranolone in Tourette Syndrome

Completed Phase 2 Last updated 9 June 2023

What this trial tests

Phase 2 trial testing Sepranolone in Tourette Syndrome in 26 participants. Completed in 1 February 2023.

Timeline

16 February 2022

Primary endpoint
1 February 2023

1 February 2023

Quick facts

Lead sponsor	Asarina Pharma
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	26
Start date	16 February 2022
Primary completion	1 February 2023
Estimated completion	1 February 2023
Sites	2 locations across Denmark

Drugs / interventions tested

• Sepranolone — full drug profile →

Conditions studied

• Tourette Syndrome — all drugs for Tourette Syndrome →
• Tourette Syndrome in Adolescence — all drugs for Tourette Syndrome in Adolescence →

Sponsor

Asarina Pharma — full company profile →

Who can join

Adults 12 to 55, any sex, with Tourette Syndrome or Tourette Syndrome in Adolescence. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Prefrontal allopregnanolone mediates the adverse effects of acute stress in a mouse model of tic pathophysiology.
   Cadeddu R, Van Zandt M, Santovito LS, Odeh K, et al · · 2023 · cited 20× · PMID 37198434 · DOI 10.1038/s41386-023-01603-6