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CompletedNCT00266344Updated Jan 14, 2015

MK0928 Study in Adult Patients With Primary Insomnia (0928-040)(COMPLETED)

A Phase 2 interventional study of MK0928, gaboxadol / Duration of Treatment 3 Weeks and Placebo / Duration of Treatment 3 Weeks in Primary Insomnia, sponsored by H. Lundbeck A/S. Completed. Open to participants aged 20 Years to 64 Years. Per ClinicalTrials.gov, last updated 2015-01-14.

Sponsored by H. Lundbeck A/S · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
520
Allocation
Randomized
Ages
20 Years to 64 Years
Sex
All
01

Study summary

A study to evaluate the efficacy, safety and tolerability of MK-0928 in Primary Insomnia.

02

Conditions studied

  • Primary Insomnia
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 520 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.

04

Who can participate

Ages eligible
20 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with a diagnosis of primary insomnia

Exclusion criteria

Exclusion Criteria:

  • Patients with an active psychiatric disorder other than primary insomnia
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
520 participants

Interventions

  • DrugMK0928, gaboxadol / Duration of Treatment 3 Weeks
  • DrugPlacebo / Duration of Treatment 3 Weeks
06

What researchers measure

Primary outcomes

  1. Patient-reported total sleep time.

Secondary outcomes

  1. Patient-reported time to sleep onset, number of awakenings, wake time after sleep onset and premature awakening.

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
NCT00266344
Lead sponsor
H. Lundbeck A/S
First posted
Dec 16, 2005
Start date
Nov 2005
Completion
Oct 2006
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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