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WithdrawnNCT00102154Updated Jan 14, 2015

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

A Phase 3 interventional study of MK0928, gaboxadol / Duration of Treatment: 10 months in Insomnia, sponsored by H. Lundbeck A/S. Withdrawn. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-01-14.

Sponsored by H. Lundbeck A/S · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
All
01

Study summary

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

02

Conditions studied

03

In context

Sleep Initiation and Maintenance Disorders

1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.

Browse Sleep Initiation and Maintenance Disorders studies →

Lead sponsor

H. Lundbeck A/S is the lead sponsor of 218 studies on the registry; 10 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 10 (30%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Adults who are diagnosed with insomnia
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
0 participants (actual)

Interventions

  • DrugMK0928, gaboxadol / Duration of Treatment: 10 months
06

What researchers measure

Primary outcomes

  1. 4-hour advanced polysomnographic (PSG) recording session measuring wake time after sleep onset (WASO) and latency to persistent sleep (LPS); Safety and tolerability

Secondary outcomes

  1. Daily sleep diary for visual analogue sleep quality and number of night awakenings (sNAW)

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 14, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00102154
Lead sponsor
H. Lundbeck A/S
First posted
Jan 24, 2005
Start date
Jan 2005
Last update
Jan 14, 2015

Study contacts

Medical Monitor
study director · Merck Sharp & Dohme LLC
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.

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