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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-505086-83-00
Acronym
NOE-TTS-201
Enrollment
130
Registered
2024-03-05
Start date
2024-07-10
Completion date
Unknown
Last updated
2025-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tourette Syndrome

Brief summary

Change in YGTSS-R total tic scores from baseline (randomization) to D85 for gemlapodect as compared to placebo

Detailed description

Change in SDS from baseline (randomization) to D85 for gemlapodect as compared to placebo, Change in TS-CGI-S scale from baseline (randomization) to D85 for gemlapodect as compared to placebo, TS-CGI-C scale at D85 for gemlapodect as compared to placebo, PGI-C scale at D85 for gemlapodect as compared to placebo, Change in PUTS from baseline (randomization) to D85 for gemlapodect as compared to placebo, Change in ADHD-RS from baseline (randomization) to D85 for gemlapodect as compared to placebo, Change in C&A-GTS-QOL subscale from baseline (randomization) to D85 for gemlapodect as compared to placebo, Change in body weight and effect on blood glucose and lipids, Incidence and severity of AEs, including SAEs and AESI, Laboratory assessments, ECG assessment, Assessment of vital signs, Suicidality assessed by C-SSRS, Plasma concentrations of gemlapodect, Assessment of bodyweight changes over time from baseline

Interventions

DRUGPlacebo

Sponsors

Noema Pharma AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change in YGTSS-R total tic scores from baseline (randomization) to D85 for gemlapodect as compared to placebo

Secondary

MeasureTime frame
Change in SDS from baseline (randomization) to D85 for gemlapodect as compared to placebo, Change in TS-CGI-S scale from baseline (randomization) to D85 for gemlapodect as compared to placebo, TS-CGI-C scale at D85 for gemlapodect as compared to placebo, PGI-C scale at D85 for gemlapodect as compared to placebo, Change in PUTS from baseline (randomization) to D85 for gemlapodect as compared to placebo, Change in ADHD-RS from baseline (randomization) to D85 for gemlapodect as compared to placebo, Change in C&A-GTS-QOL subscale from baseline (randomization) to D85 for gemlapodect as compared to placebo, Change in body weight and effect on blood glucose and lipids, Incidence and severity of AEs, including SAEs and AESI, Laboratory assessments, ECG assessment, Assessment of vital signs, Suicidality assessed by C-SSRS, Plasma concentrations of gemlapodect, Assessment of bodyweight changes over time from baseline

Countries

Belgium, France, Germany, Hungary, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026