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:	NCT00209924

Purpose

To evaluate the efficacy 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/Efficacy 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:

Efficacy
Safety
Tolerability

Estimated Enrollment:	505
Study Start Date:	April 2004
Study Completion Date:	November 2005

Detailed Description:

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

Eligibility

Ages Eligible for Study:	66 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

patients with a diagnosis of primary insomnia

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00209924

Locations

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

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:	10403
Study First Received:	September 13, 2005
Last Updated:	March 29, 2007
ClinicalTrials.gov Identifier:	NCT00209924
Health Authority:	Sweden: Medical Products Agency

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