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Study to Compare the Awakening Threshold Effects of Belsomra 10 mg and 20 mg to Placebo in Non-elderly Insomniacs

NCT03312517 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2019-11-01

Study results available
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Summary

Phase IV 3-Way Double-blind, Randomized, Crossover Study to Compare the Awakening Threshold Effects (responsivity) of Belsomra 10 mg and 20 mg to Placebo in non-elderly Insomniacs

Conditions

Interventions

DRUG

Suvorexant 10 mg

Subject will receive suvorexant 10mg

DRUG

Suvorexant 20 mg

Subject will receive suvorexant 20mg

DRUG

Placebo oral capsule

Subject will receive placebo.

Sponsors & Collaborators

  • Henry Ford Health System

    lead OTHER

Principal Investigators

  • Chris L Drake, PhD · Henry Ford Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-15
Primary Completion
2018-10-25
Completion
2018-10-25
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT03312517 on ClinicalTrials.gov