Adult Primary Insomnia Polysomnographic Study (0928-004)(COMPLETED)

A Double-Blind, Randomized, Placebo-Controlled, Multicenter, 30-Night Polysomnographic Study of MK0928 in Adult Patients With Primary Insomnia

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00094627

Enrollment

465

Registered

2004-10-22

Start date

2004-11-30

Completion date

2006-04-30

Last updated

2015-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Insomnia

Brief summary

The purpose of the study is to test the safety and effectiveness of the Investigational Drug on insomnia.

Interventions

DRUGgaboxadol

Duration of Treatment - 6 weeks

DRUGComparator: placebo (unspecified)

Duration of Treatment - 6 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Healthy volunteers

Inclusion criteria

* Adult patients with a diagnosis of primary insomnia and in good physical and mental health

Exclusion criteria

* Adult patients with other medical , neurological and sleep disorders

Design outcomes

Primary

Measure	Time frame
Amount of time spent awake and time to fall asleep at night after 2 days	After 2 days

Secondary

Measure	Time frame
Amount of time spent awake and time to fall asleep at night after 30 days	After 30 days
Amount of deep sleep after 2 days	After 2 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026