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

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To evaluate the safety and tolerability of gaboxadol in primary...

Brief Summary

Official Title: “A Prospective Open-Label Extension Study (to Study 99784) of Gaboxadol in Primary Insomnia”

To evaluate the safety and tolerability of gaboxadol in primary insomnia

  • Study Type: Interventional
  • Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Detailed Clinical Trial Description

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

Intervention(s) in this Clinical Trial

  • Drug: Gaboxadol

Outcome Measures for this Clinical Trial

Primary Measures

  • Safety
  • Tolerability

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • patients with a diagnosis of primary insomnia

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: H. Lundbeck A/S Industry

Overall Clinical Trial Officials and Contacts

Please contact: Annelies van der Hammen Legters Study Director H. Lundbeck A/S  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00209950

Study ID Number: 10440

ClinicalTrials.gov Identifier: NCT00209950

Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00209950