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NCT06315751 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of Gemlapodect (NOE-105) in Adults and Adolescents With Tourette Syndrome
A Phase 2 study of Tourette Syndrome, sponsored by Noema Pharma.
- Active
- Registry status
- Phase 2
- Development phase
- 164
- Enrollment target
- 20
- Study locations
NCT06315751: Active Phase 2 study of Tourette Syndrome, sponsored by Noema Pharma.
NCT06315751 is a Phase 2 study of Tourette Syndrome that is active but no longer recruiting, run by Noema Pharma. The registered enrollment target is 164 participants, above the 82-participant average among 33 other Tourette Syndrome trials with a reported enrollment target (100% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06315751, a Phase 2 study of Tourette Syndrome, is active but no longer recruiting, sponsored by Noema Pharma.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 164 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
YGTSS-R is a clinician rated score that evaluates number, frequency, intensity, complexity and interference of motor and phonic tics with a total score ranging from 0 to 50, with 50 being the most severe and 0 being no tics. Change in YGTSS-R total tic scores from baseline (randomization) to D85 for gemlapodect as compared to placebo. The primary estimand is the difference in means between gemlapodect and placebo for the change in the TTS of the YGTSS-R from baseline (randomization) to D85, in
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Gemlapodect
Study Locations (20)
Florida
- Noema TTS-201 Site #54 - Gulf Breeze
- Noema TTS-201 Site #05 - Hialeah
- Noema TTS-201 Site #97 - Jensen Beach
- Noema TTS-201 Site #71 - Largo
- Noema TTS-201 Site #44 - Maitland
- Noema TTS-201 Site # 74 - Miami
- Noema TTS-201 Site #56 - Miami Lakes
- Noema TTS-201 Site #61 - Orlando
California
- Noema TTS-201 Site #95 - Bellflower
- Noema TTS-201 Site #75 - Glendale
- Noema TTS-201 Site #59 - San Rafael
- Noema TTS-201 Site #21 - Walnut Creek
Georgia
- Noema TTS-201 Site #79 - Atlanta
- Noema TTS-201 Site #87 - Peachtree Corners
Arizona
- Noema TTS-201 Site #81 - Sun City
Massachusetts
- Noema TTS-201 Site #55 - Boston
Michigan
- Noema TTS-201 Site #51 - Ann Arbor
Missouri
- Noema TTS-201 Site #96 - Saint Charles
Nebraska
- Noema TTS-201 Site #93 - Lincoln
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 164 participants |
| Start Date | 2024-09-10 |
| Est. Completion | 2026-06 |
| Phase | Phase 2 |
What the registry record for NCT06315751 still lists
NCT06315751 is an interventional study that assigns participants to a tested intervention. The registered 164 participants enrollment target is mid-sized for trials with a published cap, above the 82-participant average among 33 other Tourette Syndrome trials with a reported enrollment target (100% higher).
The record links to 1 condition, with Tourette Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06315751 names 20 study sites across 9 states, led by Florida, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT06315751 about?
NCT06315751 is a clinical study titled "Efficacy and Safety of Gemlapodect (NOE-105) in Adults and Adolescents With Tourette Syndrome". 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.
What is the current status of trial NCT06315751?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 164 participants. The study started on 2024-09-10. Estimated completion is 2026-06.
What conditions does trial NCT06315751 study?
This clinical trial studies the following conditions: Tourette Syndrome.
What interventions are being tested in trial NCT06315751?
The interventions under investigation include: Placebo (DRUG), Gemlapodect (DRUG).
Who is sponsoring clinical trial NCT06315751?
This trial is sponsored by Noema Pharma, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06315751 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Tourette Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06315751's enrollment target sits among peer trials
164 5th of 33 higher than 29 of 33 other Tourette Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Tourette Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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