Back to resultsA Prospective Open-Label Extension Study of Gaboxadol in Primary Insomnia
Primary Purpose
Primary Insomnia
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Gaboxadol
Sponsored by
About this trial
This is an interventional treatment trial for Primary Insomnia focused on measuring Primary insomnia
Eligibility Criteria
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
1. Study Identification
Unique Protocol Identification Number
NCT00209950
Brief Title
A Prospective Open-Label Extension Study of Gaboxadol in Primary Insomnia
Official Title
A Prospective Open-Label Extension Study (to Study 99784) of Gaboxadol in Primary Insomnia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (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 evaluate long-term safety of gaboxadol in healthy adults.
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
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (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
18 Years
Maximum Age & Unit of Time
65 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
Regensburg
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
A Prospective Open-Label Extension Study of Gaboxadol in Primary Insomnia
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