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CompletedNCT00102167Updated Jan 14, 2015

Study of MK0928 in Healthy Adult Volunteers in a Model of Insomnia (0928-006)(COMPLETED)

A Phase 3 interventional study of gaboxadol in Insomnia, sponsored by H. Lundbeck A/S. Completed. 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
663
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
All
01

Study summary

A study to evaluate the safety and effectiveness of Study of MK0928 in Healthy Adult Volunteers in a Model of Insomnia for insomnia (a sleep disorder).

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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.

This study's enrollment of 663 is above the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.

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.

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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
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Study design

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

Interventions

  • Druggaboxadol

    Duration of Treatment -1 day

    Also known as: MK0928

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What researchers measure

Primary outcomes

  1. Amount of time spent awake and time to fall asleep during one night

    Time frame: one night

Secondary outcomes

  1. Amount of deep sleep during one night.

    Time frame: one night

  2. Patient-reported sleep quality and awakenings during 1 night.

    Time frame: one night

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Walsh JK, Mayleben D, Guico-Pabia C, Vandormael K, Martinez R, Deacon S. Efficacy of the selective extrasynaptic GABA A agonist, gaboxadol, in a model of transient insomnia: a randomized, controlled clinical trial. Sleep Med. 2008 May;9(4):393-402. doi: 10.1016/j.sleep.2007.06.006. Epub 2007 Aug 30. PubMed 17765013 ↗
  • Ma J, Dijk DJ, Svetnik V, Tymofyeyev Y, Ray S, Walsh JK, Deacon S. EEG power spectra response to a 4-h phase advance and gaboxadol treatment in 822 men and women. J Clin Sleep Med. 2011 Oct 15;7(5):493-501A. doi: 10.5664/JCSM.1316. PubMed 22003345 ↗
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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 ↗
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Registry details

Key details

Study ID
NCT00102167
Lead sponsor
H. Lundbeck A/S
First posted
Jan 24, 2005
Start date
Feb 2005
Completion
Dec 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 completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

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