An Investigational Drug Study in Healthy Adult Volunteers in a Model of Insomnia (0928-007)

A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Study of MK0928 in Healthy Adult Volunteers Participating in a 4-Hour Phase Advance Model of Transient Insomnia

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00102154

Enrollment

Registered

2005-01-24

Start date

2005-01-31

Completion date

Unknown

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

Insomnia

Brief summary

A study to evaluate the safety and effectiveness of an investigational drug for insomnia (a sleep disorder).

Interventions

DRUGMK0928, gaboxadol / Duration of Treatment: 10 months

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

Yes

Inclusion criteria

* Healthy adults who are between the ages of 18 and 64

Exclusion criteria

* Adults who are diagnosed with insomnia

Design outcomes

Primary

Measure	Time frame
4-hour advanced polysomnographic (PSG) recording session measuring wake time after sleep onset (WASO) and latency to persistent sleep (LPS); Safety and tolerability	—

Secondary

Measure	Time frame
Daily sleep diary for visual analogue sleep quality and number of night awakenings (sNAW)	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026