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NCT02353299 · ClinicalTrials.gov registry record · Phase 4
Assess the Effect of Zolpidem, Silenor & Placebo on Arousability, Ataxia/Balance & Cognition in Healthy Volunteers
A Phase 4 study of Healthy, sponsored by Currax Pharmaceuticals.
- Completed
- Registry status
- Phase 4
- Development phase
- 52
- Enrollment target
- 1
- Study location
NCT02353299: Completed Phase 4 study of Healthy, sponsored by Currax Pharmaceuticals.
NCT02353299 is a Phase 4 study of Healthy that has completed, run by Currax Pharmaceuticals. The registered enrollment target is 52 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02353299, a Phase 4 study of Healthy, has completed, sponsored by Currax Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 52 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase IV, randomized, double-blind, placebo-controlled, four-arm crossover study. The study will assess the effects of a single dose of Silenor 6 mg compared with matching placebo and a single dose of zolpidem 10 mg compared to its matching placebo at the respective T-max in normal healthy adult male volunteers. The study will be conducted in approximately 52 male subjects
Primary Outcome
AAT will performed at T-max for Silenor and matching placebo at 4 hours post dose. Assessments performed at t max for zolpidem and placebo at 1.5 hours post dose. An acoustic stimulus (1000 Hz tone) was presented through audiometric earphones (E-A-RTone 3A Insert Earphones). Tones began at 30 dB and increased by 5 dB until the participant woke up or the maximum dB-level (110 dB) was reached.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Silenor 6 mg
- DRUG zolpidem 10 mg
Study Locations (1)
Michigan
- Henry Ford Hospital Sleep Disorders & Research Center - Novi
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2015-01 |
| Est. Completion | 2016-03 |
| Phase | Phase 4 |
What the finished NCT02353299 record still lists
NCT02353299 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT02353299 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT02353299 about?
NCT02353299 is a clinical study titled "Assess the Effect of Zolpidem, Silenor & Placebo on Arousability, Ataxia/Balance & Cognition in Healthy Volunteers". This is a Phase IV, randomized, double-blind, placebo-controlled, four-arm crossover study. The study will assess the effects of a single dose of Silenor 6 mg compared with matching placebo and a single dose of zolpidem 10 mg compared to its matching placebo at the respective T-max in normal healthy...
What is the current status of trial NCT02353299?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 52 participants. The study started on 2015-01. Estimated completion is 2016-03.
What conditions does trial NCT02353299 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT02353299?
The interventions under investigation include: Placebo (DRUG), Silenor 6 mg (DRUG), zolpidem 10 mg (DRUG).
Who is sponsoring clinical trial NCT02353299?
This trial is sponsored by Currax Pharmaceuticals, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02353299 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
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 NCT02353299's enrollment target sits among peer trials
52 441st of 1090 higher than 646 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy 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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