A Prospective Active-Reference Study of Gaboxadol in Primary Insomnia

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

Completed

Looking for future studies?

Key information

Conditions

Primary Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

diagnosis of Primary insomnia

Treatment and study plan

Gaboxadol

Drug

Primary outcomes

Efficacy
Safety
Tolerability

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study title

A Prospective Randomised Double-Blind Parallel-Group Placebo-Controlled Active-Reference Study of Gaboxadol in Primary Insomnia

Important dates

Study start: 2003
Study completion: 2004
First posted: Sep 21, 2005
Registry last updated: Mar 30, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed