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NCT02947048 · ClinicalTrials.gov registry record · Phase 2
Safety of L1-79 in Adolescent and Adult Males With Autism
A Phase 2 study, sponsored by Yamo Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 42
- Enrollment target
NCT02947048: Completed Phase 2 study, sponsored by Yamo Pharmaceuticals.
NCT02947048 is a Phase 2 study that has completed, run by Yamo Pharmaceuticals. The registered enrollment target is 42 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02947048, a Phase 2 study, has completed, sponsored by Yamo Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 42 participants
- Enrollment target
Study Summary
This is a five-arm designed to assess the safety of L1-79 that incorporates 15 prospectively randomized, placebo controlled patients and 5 open label patients at either 100 tid (three times daily) or 200 tid dosing for 28 days. The open label patients will be assessed for the purpose of understanding PK/PD and to determine if there are any EKG changes associated with the administration of L1-79. Additional safety information will be provided by the 30 patients randomized 2:1 active:placebo.
Primary Outcome
Number of Participants with On-treatment Adverse Events. To be conservative, it was pre-specified that all placebo data be combined (open-label, first cohort, and second cohort) for the safety population. For the efficacy population open-label data was excluded due to potential bias and placebo arms from the first and second cohort were presented separately due to differences in efficacy questionnaires completion in the first and second cohorts. Theses differences were not relevant to the adver
Interventions
- DRUG Placebo
- DRUG L1-79
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2016-10 |
| Est. Completion | 2018-02-01 |
| Phase | Phase 2 |
What the finished NCT02947048 record still lists
NCT02947048 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02947048 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02947048 about?
NCT02947048 is a clinical study titled "Safety of L1-79 in Adolescent and Adult Males With Autism". This is a five-arm designed to assess the safety of L1-79 that incorporates 15 prospectively randomized, placebo controlled patients and 5 open label patients at either 100 tid (three times daily) or 200 tid dosing for 28 days. The open label patients will be assessed for the purpose of understandin...
What is the current status of trial NCT02947048?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2016-10. Estimated completion is 2018-02-01.
What interventions are being tested in trial NCT02947048?
The interventions under investigation include: Placebo (DRUG), L1-79 (DRUG).
Who is sponsoring clinical trial NCT02947048?
This trial is sponsored by Yamo Pharmaceuticals, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02947048's enrollment target sits among peer trials
42 1339th of 2000 higher than 649 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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