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A Prospective Open-Label Extension Study of Gaboxadol in Primary Insomnia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00209950
First Posted: September 21, 2005
Last Update Posted: March 30, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
H. Lundbeck A/S
  Purpose
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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with a diagnosis of primary insomnia
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00209950     History of Changes
Other Study ID Numbers: 10440
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: March 30, 2007
Last Verified: March 2007

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

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Gaboxadol
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action