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NCT00209963 Clinical Trial

A Study of Gaboxadol in Primary Insomnia

Primary Insomnia Clinical Trial

Official title:
A Prospective Randomised Double-Blind Parallel-Group Placebo-Controlled Study of Gaboxadol in Primary Insomnia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00209963
Other study ID # 99784
Secondary ID
Status Completed
Phase Phase 3
First received September 13, 2005
Last updated March 29, 2007
Start date June 2003
Est. completion date March 2005

Study information
Verified date March 2007
Source H. Lundbeck A/S
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

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

Description:

To obtain long-term safety and tolerability data with gaboxadol.

Recruitment information / eligibility
Status Completed
Enrollment 600
Est. completion date March 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- patients with Primary insomnia

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Gaboxadol

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
H. Lundbeck A/S

Outcome
Type Measure Description Time frame Safety issue
Primary Long-term safety in gaboxadol.
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