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A Study to Explore the Effect of Sepranolone in Tourette Syndrome

NCT05434546 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2023-06-09

No results posted yet for this study

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 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

Conditions

  • Tourette Syndrome
  • Tourette Syndrome in Adolescence

Interventions

DRUG

Sepranolone

Treatment with 10 mg Sepranolone s.c. twice weekly for 12 weeks alongside patient's standard of care Tourette treatment.

Sponsors & Collaborators

  • Asarina Pharma

    lead INDUSTRY

Principal Investigators

  • Nanette Debes, MD · Copenhagen University Hospital at Herlev

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-16
Primary Completion
2023-02-01
Completion
2023-02-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05434546 on ClinicalTrials.gov