An Investigational Drug Study in Healthy Adult Volunteers in a Model of Insomnia (0928-007)

Phase 3

Withdrawn

• Conditions: Insomnia

• Registration Number: NCT00102154
• Lead Sponsor: H. Lundbeck A/S

Brief Summary

A study to evaluate the safety and effectiveness of an investigational drug for insomnia (a sleep disorder).

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2005-01-21
• Study First Submitted QC: 2005-01-21
• Study First Posted: 2005-01-24
• Status Verified: 2014-08
• Last Update Submitted: 2015-01-13
• Last Update Posted: 2015-01-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Healthy adults who are between the ages of 18 and 64

Exclusion Criteria

• Adults who are diagnosed with insomnia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
4-hour advanced polysomnographic (PSG) recording session measuring wake time after sleep onset (WASO) and latency to persistent sleep (LPS); Safety and tolerability

Secondary Outcome Measures

Name	Time	Method
Daily sleep diary for visual analogue sleep quality and number of night awakenings (sNAW)