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CompletedNCT00095069Updated Jan 14, 2015

Efficacy and Safety of MK0928 for Insomnia in Adults (0928-003)(COMPLETED)

A Phase 3 interventional study of MK0928, gaboxadol / Duration of Treatment - 1 year and Comparator: placebo / Duration of Treatment -1 year in Insomnia, sponsored by H. Lundbeck A/S. Completed. Open to participants aged 18 Years to 64 Years. 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
600
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
All
01

Study summary

The purpose of this trial is to study the safety and effectiveness of MK0928 for adults with insomnia.

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.

This study's enrollment of 600 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
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • Diagnosis of insomnia
05

Study design

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

Interventions

  • DrugMK0928, gaboxadol / Duration of Treatment - 1 year
  • DrugComparator: placebo / Duration of Treatment -1 year
06

What researchers measure

Primary outcomes

  1. Patient-reported amount of sleep and time to fall sleep at night after three months

Secondary outcomes

  1. Patient-reported awakenings at night

  2. Sleep quality

  3. Functioning after 3 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Roth T, Lines C, Vandormael K, Ceesay P, Anderson D, Snavely D. Effect of gaboxadol on patient-reported measures of sleep and waking function in patients with Primary Insomnia: results from two randomized, controlled, 3-month studies. J Clin Sleep Med. 2010 Feb 15;6(1):30-9. PubMed 20191935 ↗
09

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 ↗
10

Registry details

Key details

Study ID
NCT00095069
Lead sponsor
H. Lundbeck A/S
First posted
Nov 1, 2004
Start date
Oct 2004
Primary completion
Feb 2007
Completion
Feb 2007
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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