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NCT03166501 · ClinicalTrials.gov registry record · Phase 1
NMDA Receptor Modulation for Hyperarousal in PTSD
A Phase 1 study, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT03166501: Completed Phase 1 study, sponsored by Baylor College of Medicine.
NCT03166501 is a Phase 1 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03166501, a Phase 1 study, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
This Phase 1b study examines the safety and efficacy of parenterally-administered lanicemine in a parallel-arm, randomized, double-blind, placebo-controlled trial in adult patients (N=24) with significant PTSD symptoms and elevated anxiety potentiated startle (APS). Investigator hypothesize that lanicemine (100 mg) displays a normalization of APS following three infusions over 5 non-consecutive days. If target engagement is demonstrated and the drug is safe and tolerable in this patient population, investigator will proceed to a larger POC study.
Primary Outcome
Primary Objective is to examine, relative to placebo, whether lanicemine will demonstrate normalization of the APS response following three treatments.
Interventions
- DRUG Placebo
- DRUG Lanicemine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2018-09-01 |
| Est. Completion | 2019-11-14 |
| Phase | Phase 1 |
What the finished NCT03166501 record still lists
NCT03166501 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03166501 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03166501 about?
NCT03166501 is a clinical study titled "NMDA Receptor Modulation for Hyperarousal in PTSD". This Phase 1b study examines the safety and efficacy of parenterally-administered lanicemine in a parallel-arm, randomized, double-blind, placebo-controlled trial in adult patients (N=24) with significant PTSD symptoms and elevated anxiety potentiated startle (APS). Investigator hypothesize that lan...
What is the current status of trial NCT03166501?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2018-09-01. Estimated completion is 2019-11-14.
What interventions are being tested in trial NCT03166501?
The interventions under investigation include: Placebo (DRUG), Lanicemine (DRUG).
Who is sponsoring clinical trial NCT03166501?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03166501's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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