Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06315751
Status:
RECRUITING
Last Update Posted:
2024-03-18
First Post:
2023-12-06
Brief Title:
Efficacy and Safety of Gemlapodect NOE-105 in Adults and Adolescents With Tourette Syndrome
Sponsor:
Noema Pharma AG
Organization:
Noema Pharma AG
Study Overview
Official Title:
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:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Allevia2
Brief 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 11 on Day 1 to receive gemlapodect or placebo once daily for 12 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None