A Study of Gaboxadol in Primary Insomnia

This study has been completed.

Sponsored by:	H. Lundbeck A/S
Information provided by:	H. Lundbeck A/S
ClinicalTrials.gov Identifier:	NCT00209963

Purpose

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

Condition	Intervention	Phase
Primary Insomnia	Drug: Gaboxadol	Phase III

Drug Information available for: Gaboxadol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study
Official Title:	A Prospective Randomised Double-Blind Parallel-Group Placebo-Controlled Study of Gaboxadol in Primary Insomnia

Further study details as provided by H. Lundbeck A/S:

Primary Outcome Measures:

Long-term safety in gaboxadol.

Estimated Enrollment:	600
Study Start Date:	June 2003
Study Completion Date:	March 2005

Detailed Description:

To obtain long-term safety and tolerability data with gaboxadol.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

patients with Primary insomnia

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00209963

Sponsors and Collaborators

H. Lundbeck A/S

Investigators

Study Director:

Please contact: Annelies van der Hammen Legters

H. Lundbeck A/S

More Information

Study ID Numbers:	99784
Study First Received:	September 13, 2005
Last Updated:	March 29, 2007
ClinicalTrials.gov Identifier:	NCT00209963
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by H. Lundbeck A/S:

Primary insomnia

Study placed in the following topic categories:

4,5,6,7-tetrahydroisoxazolo(5,4-c)pyridin-3-ol
Sleep Initiation and Maintenance Disorders
Mental Disorders

Dyssomnias
Sleep Disorders
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Therapeutic Uses

GABA Agonists
GABA Agents
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on January 16, 2009