Tourette Syndrome
Conditions
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
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in YGTSS-R total tic scores from baseline (randomization) to D85 for gemlapodect as compared to placebo | — |
Secondary
| Measure | Time 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