A Study of Gaboxadol in Primary Insomnia

This study has been completed.
Information provided by:
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
First received: September 13, 2005
Last updated: March 29, 2007
Last verified: March 2007
To evaluate the safety and tolerability of gaboxadol in primary insomnia.

Condition Intervention Phase
Primary Insomnia
Drug: Gaboxadol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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.

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

Inclusion Criteria:

  • patients with Primary insomnia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
H. Lundbeck A/S
Study Director: Please contact: Annelies van der Hammen Legters H. Lundbeck A/S
  More Information

No publications provided

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

Keywords provided by H. Lundbeck A/S:
Primary insomnia

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Mental Disorders
Nervous System Diseases
Sleep Disorders
Sleep Disorders, Intrinsic
Central Nervous System Agents
GABA Agents
GABA Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 08, 2016