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NCT02614586 · ClinicalTrials.gov registry record · Phase 1
Evaluation of TAK-058 and Ondansetron on P50 Auditory Gating in Participants With Stable Schizophrenia
A Phase 1 study, sponsored by Takeda.
- Terminated
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
NCT02614586: Clinical Trial Phase 1 study, sponsored by Takeda.
NCT02614586 is a Phase 1 study that was terminated before completion, run by Takeda. The registered enrollment target is 11 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02614586, a Phase 1 study, was terminated before completion, sponsored by Takeda.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether improvement in P50 (a pharmacodynamic marker) in auditory sensory gating is demonstrated after administration of TAK-058 and ondansetron compared to placebo in participants with schizophrenia.
Primary Outcome
Participants were planned to check for P50 gating ratio. Stimulus signal of 90 decibel pulses of 0.1 millisecond (msec) was to be generated and recorded the event-related potential waveforms. 32 pairs of auditory clicks were to be presented every 10 seconds, with a 500 msec interclick interval. S1 is defined as the conditioning P50 wave with the most positive peak between 30 and 90 msec after the conditioning stimulus. S2 is defined as the test P50 wave with the positive peak after the test stim
Interventions
- DRUG Ondansetron
- DRUG Ondansetron Placebo
- DRUG TAK-058
- DRUG TAK-058 Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2015-12 |
| Est. Completion | 2016-04 |
| Phase | Phase 1 |
Why NCT02614586 stopped before completion
NCT02614586 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 4 interventions - of which Ondansetron is the first listed.
NCT02614586 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02614586 about?
NCT02614586 is a clinical study titled "Evaluation of TAK-058 and Ondansetron on P50 Auditory Gating in Participants With Stable Schizophrenia". The purpose of this study is to determine whether improvement in P50 (a pharmacodynamic marker) in auditory sensory gating is demonstrated after administration of TAK-058 and ondansetron compared to placebo in participants with schizophrenia.
What is the current status of trial NCT02614586?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2015-12. Estimated completion is 2016-04.
What interventions are being tested in trial NCT02614586?
The interventions under investigation include: Ondansetron (DRUG), Ondansetron Placebo (DRUG), TAK-058 (DRUG), TAK-058 Placebo (DRUG).
Who is sponsoring clinical trial NCT02614586?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02614586's enrollment target sits among peer trials
11 1911th of 2000 higher than 88 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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