NCT00209924

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
505

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Apr 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

March 30, 2007

Status Verified

March 1, 2007

First QC Date

September 13, 2005

Last Update Submit

March 29, 2007

Conditions

Primary Insomnia

Keywords

Primary insomnia

Outcome Measures

Primary Outcomes (3)

  • Efficacy

  • Safety

  • Tolerability

Interventions

GaboxadolDRUG

Eligibility Criteria

Age66 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • patients with a diagnosis of primary insomnia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Non-US study, principal location:

Gothenburg, Sweden

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

gaboxadol

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Please contact: Annelies van der Hammen Legters

    H. Lundbeck A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

April 1, 2004

Study Completion

November 1, 2005

Last Updated

March 30, 2007

Record last verified: 2007-03

Locations

SE(1)