A Prospective Open-Label Extension Study of Gaboxadol in Primary Insomnia

Phase 3

Completed

• Conditions: Primary Insomnia

• Registration Number: NCT00209950
• Lead Sponsor: H. Lundbeck A/S

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.

Study Timeline

• Study Start: 2004-07
• Study Completion: 2005-09
• 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: 200

Inclusion Criteria

• patients with a diagnosis of primary insomnia

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety
Tolerability

Trial Locations

Locations (1)

Non-US study, principal location: 🇩🇪 Regensburg, Germany