NCT00209950

Brief Summary

To evaluate the 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
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2004

Shorter than P25 for phase_3

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

July 1, 2004

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
12 days 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
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 (2)

  • Safety

  • Tolerability

Interventions

GaboxadolDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older 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:

Regensburg, Germany

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
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

July 1, 2004

Study Completion

September 1, 2005

Last Updated

March 30, 2007

Record last verified: 2007-03

Locations

DE(1)