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A Study of Gaboxadol in Primary Insomnia

Primary Purpose

Primary Insomnia

Status
Completed
Phase
Phase 3
Locations
Sweden
Study Type
Interventional
Intervention
Gaboxadol
Sponsored by
H. Lundbeck A/S
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Insomnia focused on measuring Primary insomnia

Eligibility Criteria

66 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: patients with a diagnosis of primary insomnia

Sites / Locations

  • Non-US study, principal location:

Outcomes

Primary Outcome Measures

Safety
Tolerability

Secondary Outcome Measures

Full Information

First Posted
September 13, 2005
Last Updated
March 29, 2007
Sponsor
H. Lundbeck A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00209846
Brief Title
A Study of Gaboxadol in Primary Insomnia
Official Title
A Prospective Randomised Double-Blind Parallel-Group Placebo-Controlled Study of Gaboxadol in Primary Insomnia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
H. Lundbeck A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate the safety and tolerability of gaboxadol in primary insomnia.
Detailed Description
To obtain long-term safety data in elderly patients with gaboxadol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Insomnia
Keywords
Primary insomnia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
320 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Gaboxadol
Primary Outcome Measure Information:
Title
Safety
Title
Tolerability

10. Eligibility

Sex
All
Minimum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients with a diagnosis of primary insomnia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Please contact: Annelies van der Hammen Legters
Organizational Affiliation
H. Lundbeck A/S
Official's Role
Study Director
Facility Information:
Facility Name
Non-US study, principal location:
City
Göteborg
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

A Study of Gaboxadol in Primary Insomnia

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