A Prospective Active-Reference Study of Gaboxadol in Primary Insomnia

Phase 3

Completed

• Conditions: Primary Insomnia

• Registration Number: NCT00209937
• Lead Sponsor: H. Lundbeck A/S

Brief Summary

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

Detailed Description

To compare the hypnotic efficacy and safety of different dose levels of gaboxadol with placebo in non-elderly patients with primary insomnia over two weeks of treatment

Study Timeline

• Study Start: 2003-01
• Study Completion: 2004-06
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Status Verified: 2007-03
• Last Update Submitted: 2007-03-29
• Last Update Posted: 2007-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 675

Inclusion Criteria

• diagnosis of Primary insomnia

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Tolerability
Efficacy
Safety