CClinicalTrials.gg
CompletedNCT00209937Updated Mar 30, 2007

A Prospective Active-Reference Study of Gaboxadol in Primary Insomnia

A Phase 3 interventional study of Gaboxadol in Primary Insomnia, sponsored by H. Lundbeck A/S. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2007-03-30.

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

Phase
Phase 3
Study type
Interventional
Enrollment
675
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

To evaluate the efficacy safety and tolerability of gaboxadol in primary insomnia

Read the detailed description

To compare the hypnotic efficacy and safety of different dose levels of gaboxadol with placebo in non-elderly patients with primary insomnia over two weeks of treatment

02

Conditions studied

  • Primary Insomnia

Keywords

  • 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 675 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 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • diagnosis of Primary insomnia
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
675 participants

Interventions

  • DrugGaboxadol
06

What researchers measure

Primary outcomes

  1. Efficacy

  2. Safety

  3. Tolerability

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 Mar 30, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00209937
Lead sponsor
H. Lundbeck A/S
First posted
Sep 21, 2005
Start date
Jan 2003
Completion
Jun 2004
Last update
Mar 30, 2007

Study contacts

Please contact: Annelies van der Hammen Legters
study director · H. Lundbeck A/S

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2007. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion