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

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ClinicalTrials.gov Identifier: NCT00209950
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : March 30, 2007
Information provided by:
H. Lundbeck A/S

Brief Summary:
To evaluate the safety and tolerability of gaboxadol in primary insomnia

Condition or disease Intervention/treatment Phase
Primary Insomnia Drug: Gaboxadol Phase 3

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
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
Study Start Date : July 2004
Study Completion Date : September 2005

Primary Outcome Measures :
  1. Safety
  2. Tolerability

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

Inclusion Criteria:

  • patients with a diagnosis of primary insomnia

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

Non-US study, principal location:
Regensburg, Germany
Sponsors and Collaborators
H. Lundbeck A/S
Study Director: Please contact: Annelies van der Hammen Legters H. Lundbeck A/S

ClinicalTrials.gov Identifier: NCT00209950     History of Changes
Other Study ID Numbers: 10440
First Posted: September 21, 2005    Key Record Dates
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
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action