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Assess the Effect of Zolpidem, Silenor & Placebo on Arousability, Ataxia/Balance & Cognition in Healthy Volunteers

NCT02353299 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2018-01-02

Study results available
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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

Conditions

  • Healthy

Interventions

DRUG

Silenor 6 mg

Silenor 6 mg single nighttime dose.

DRUG

zolpidem 10 mg

Zolpidem 10 mg single nighttime dose

DRUG

Placebo

placebo single nighttime dose-1.5 hours

DRUG

Placebo

placebo single nighttime dose-4 hours

Sponsors & Collaborators

  • Henry Ford Hospital

    collaborator OTHER

  • Currax Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Chris Drake, PhD · Henry Ford Hospital Sleep Disorder Research Center

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2016-01-31
Completion
2016-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02353299 on ClinicalTrials.gov