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A Study of Gaboxadol in Primary Insomnia

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ClinicalTrials.gov Identifier: NCT00209924
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : March 30, 2007
Sponsor:
Information provided by:
H. Lundbeck A/S

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

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

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

Study Type : Interventional  (Clinical Trial)
Enrollment : 505 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Prospective Randomised Double-Blind Parallel-Group Placebo-Controlled Study of Gaboxadol in Primary Insomnia
Study Start Date : April 2004
Actual Study Completion Date : November 2005



Primary Outcome Measures :
  1. Efficacy
  2. Safety
  3. Tolerability


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Ages Eligible for Study:   66 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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): 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

ClinicalTrials.gov Identifier: NCT00209924     History of Changes
Other Study ID Numbers: 10403
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
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