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NCT05067582 · ClinicalTrials.gov registry record · Phase 2
A 12-Week Crossover Study to Assess the Efficacy, Safety and Tolerability of L1-79 in Subjects Aged 12-21 Years With Autism Spectrum Disorder
A Phase 2 study of Autism Spectrum Disorder and Autism, sponsored by Yamo Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 58
- Enrollment target
- 8
- Study locations
NCT05067582: Completed Phase 2 study of Autism Spectrum Disorder and Autism, sponsored by Yamo Pharmaceuticals.
NCT05067582 is a Phase 2 study of Autism Spectrum Disorder and Autism that has completed, run by Yamo Pharmaceuticals. The registered enrollment target is 58 participants, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (57% lower). The trial reports 8 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05067582, a Phase 2 study of Autism Spectrum Disorder and Autism, has completed, sponsored by Yamo Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 58 participants
- Enrollment target
- 8
- Study locations
Study Summary
This study will investigate the efficacy, safety and tolerability of L1-79 in participants aged 12-21 years who have been diagnosed with ASD with a score of \>/= 70 on the Wechsler Abbreviated Scale of Intelligence (WASI-II), and a score of \>/= 4 on the Clinical Global Impression of Severity of Illness (CGI-S) weighted for socialization.
Primary Outcome
at least 1 point improvement in 2/3 socialization subdomains or at least 3 point improvement in socialization domain
Conditions Studied
Interventions
- DRUG L1-79
Study Locations (8)
California
- Thompson Autism Center CHOC - Orange
- Cortica - San Rafael
Arizona
- Southwest Autism Research and Resource Center - Phoenix
Illinois
- Rush University - Chicago
Missouri
- Thompson Center for Autism and Neurodevelopmental Disorders - Columbia
New York
- Center for Autism and The Developing Brain - White Plains
Ohio
- Ohio State University - Columbus
Texas
- Red Oak Psychiatry Associates - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2022-01-25 |
| Est. Completion | 2024-06-21 |
| Phase | Phase 2 |
What the finished NCT05067582 record still lists
NCT05067582 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (57% lower).
The record links to 2 conditions, with Autism Spectrum Disorder appearing as the primary indexed condition, and to 1 intervention - of which L1-79 is the first listed.
NCT05067582 lists 8 locations in 7 states (California, Arizona, Illinois).
Frequently Asked Questions
What is clinical trial NCT05067582 about?
NCT05067582 is a clinical study titled "A 12-Week Crossover Study to Assess the Efficacy, Safety and Tolerability of L1-79 in Subjects Aged 12-21 Years With Autism Spectrum Disorder". This study will investigate the efficacy, safety and tolerability of L1-79 in participants aged 12-21 years who have been diagnosed with ASD with a score of \>/= 70 on the Wechsler Abbreviated Scale of Intelligence (WASI-II), and a score of \>/= 4 on the Clinical Global Impression of Severity of Ill...
What is the current status of trial NCT05067582?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 58 participants. The study started on 2022-01-25. Estimated completion is 2024-06-21.
What conditions does trial NCT05067582 study?
This clinical trial studies the following conditions: Autism Spectrum Disorder, Autism.
What interventions are being tested in trial NCT05067582?
The interventions under investigation include: L1-79 (DRUG).
Who is sponsoring clinical trial NCT05067582?
This trial is sponsored by Yamo Pharmaceuticals, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05067582 being conducted?
This trial has 8 study locations across Arizona, California, Illinois, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05067582's enrollment target sits among peer trials
58 131st of 224 higher than 92 of 224 other Autism Spectrum Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Autism Spectrum Disorder 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.
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