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Trial record 15 of 95 for:    Narcolepsy

Trial of Xyrem® (Sodium Oxybate) for the Treatment of Narcolepsy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00132873
First Posted: August 22, 2005
Last Update Posted: November 25, 2013
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:
Jazz Pharmaceuticals
  Purpose

This is a long-term, open-label, extension of the OMC-SXB-7 trial. Participants from the OMC-SXB-7 open-label trial may be entered without any requirement as to length of participation in that trial.

Approximately 70 patients are expected to participate at up to 6 investigative centers located in Canada. The trial will continue for up to 24 months or until marketing approval, whichever occurs sooner.


Condition Intervention Phase
Narcolepsy Drug: Xyrem (sodium oxybate) oral solution Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Long-Term, Open-Label, Multi-Center Extension Trial of Xyrem® (Sodium Oxybate) Oral Solution for the Treatment of Narcolepsy

Resource links provided by NLM:


Further study details as provided by Jazz Pharmaceuticals:

Primary Outcome Measures:
  • Adverse Experiences [ Time Frame: continuous ]
    Number of Subjects with treatment-emergent adverse events.

  • Vital Signs [ Time Frame: At 1 year ]
    Average Respiratory Rate at 1 year.


Enrollment: 59
Study Start Date: October 2004
Study Completion Date: December 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Xyrem (sodium oxybate) oral solution
    Xyrem (sodium oxybate) oral solution
Detailed Description:

This trial will be conducted as a long-term, open-label, extension of the OMC-SXB-7 trial. Participants from the OMC-SXB-7 open-label trial may be entered without any requirement as to length of participation in that trial.

Approximately 70 patients are expected to participate at up to 6 investigative centers located in Canada. The trial will continue for up to 24 months or until marketing approval, whichever occurs sooner.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Remained on satisfactory treatment with Xyrem® therapy in the OMC-SXB-7 trial
  • Signed and dated an informed consent
  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): NCT00132873


Locations
Canada, Ontario
Brain and Sleep Diagnostic Centre
Toronto, Ontario, Canada, M8X 2W2
Sponsors and Collaborators
Jazz Pharmaceuticals
  More Information

Responsible Party: Senir Director, Clinical Development - Psychiatry, Jazz Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT00132873     History of Changes
Other Study ID Numbers: OMC-SXB-27
First Submitted: August 18, 2005
First Posted: August 22, 2005
Results First Submitted: September 18, 2013
Results First Posted: November 25, 2013
Last Update Posted: November 25, 2013
Last Verified: September 2013

Keywords provided by Jazz Pharmaceuticals:
Narcolepsy
Cataplexy

Additional relevant MeSH terms:
Narcolepsy
Disorders of Excessive Somnolence
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Pharmaceutical Solutions
Sodium Oxybate
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs


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