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A Study of Gaboxadol in Primary Insomnia

This study has been completed.
Sponsor:
Information provided by:
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT00209846
First received: September 13, 2005
Last updated: March 29, 2007
Last verified: March 2007
History of Changes
  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: 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:
  • Safety
  • Tolerability

Estimated Enrollment: 320
Study Start Date: June 2004
Study Completion Date: November 2006
Detailed Description:

To obtain long-term safety data in elderly patients with gaboxadol.

  Eligibility

Ages Eligible for Study:   66 Years and older
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: NCT00209846

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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00209846     History of Changes
Other Study ID Numbers: 10402
Study First Received: September 13, 2005
Last Updated: March 29, 2007
Health Authority: Sweden: Medical Products Agency

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

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders
4,5,6,7-tetrahydroisoxazolo(5,4-c)pyridin-3-ol
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
 Pharmacologic Actions
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 21, 2013