A Study of Gaboxadol in Primary Insomnia

Phase 3

Completed

• Conditions: Primary Insomnia

• Registration Number: NCT00209924
• Lead Sponsor: H. Lundbeck A/S

Brief Summary

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

Detailed Description

To compare hypnotic efficacy of gaboxadol with placebo in elderly outpatients with primary insomnia

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Study Completion: 2005-11
• Status Verified: 2007-03
• Last Update Submitted: 2007-03-29
• Last Update Posted: 2007-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 505

Inclusion Criteria

• patients with a diagnosis of primary insomnia

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Efficacy
Safety
Tolerability

Trial Locations

Locations (1)

Non-US study, principal location: 🇸🇪 Göteborg, Sweden