NCT06315751

Efficacy and Safety of Gemlapodect (NOE-105) in Adults and Adolescents With Tourette Syndrome

A Double-blind, Placebo-controlled, Phase 2b, Multi-center, Twelve-week Prospective Study to Evaluate the Efficacy and Safety of Gemlapodect in Adult and Adolescent Patients With Tourette Syndrome

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 164 (actual)
• Sponsor: Noema Pharma AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to evaluate the efficacy and safety of gemlapodect (NOE-105) on reducing tics associated with Tourette Syndrome (TS) in adults with TS. Adolescents will be enrolled after a sentinel cohort of adults is complete.

Detailed description

Gemlapodect is an investigational selective PDE10A inhibitor with a potential therapeutic effect for the treatment of tics associated with Tourette Syndrome (TS). This is a multi-center, double-blind, parallel-arm, placebo-controlled study in patients with TS. Following screening to confirm eligibility and to wash-out previous TS medication during a 14-day placebo run-in, patients will be randomized 1:1 on Day 1 to receive gemlapodect or placebo once daily for 12 weeks. See https://allevia2study.com

Conditions

• Tourette Syndrome

Interventions

Type	Name	Description
DRUG	Gemlapodect	Gemlapodect is an investigational selective PDE10A inhibitor with a potential therapeutic effect for the treatment of tics associated with TS. Administered in the form of oral capsules.
DRUG	Placebo	Administered in the form of oral capsules with inert ingredients.

Timeline

• Start date: 2024-09-10
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2024-03-18
• Last updated: 2026-03-09

Locations

46 sites across 7 countries: United States, Belgium, France, Germany, Hungary, Poland, Spain

Regulatory

• FDA-regulated drug study