A Prospective Open-Label Extension 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:	NCT00209950

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, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	A Prospective Open-Label Extension Study (to Study 99784) of Gaboxadol in Primary Insomnia

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

Primary Outcome Measures:

Safety
Tolerability

Estimated Enrollment:	200
Study Start Date:	July 2004
Study Completion Date:	September 2005

Detailed Description:

To evaluate long-term safety of gaboxadol in healthy adults.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
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: NCT00209950

Locations

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

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:	10440
Study First Received:	September 13, 2005
Last Updated:	March 29, 2007
ClinicalTrials.gov Identifier:	NCT00209950
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