Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
ClinicalTrials.gov Identifier: NCT00132873
Recruitment Status : Completed
First Posted : August 22, 2005
Results First Posted : November 25, 2013
Last Update Posted : November 25, 2013
Sponsor:
Information provided by:
Jazz Pharmaceuticals

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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 or disease Intervention/treatment Phase
Narcolepsy Drug: Xyrem (sodium oxybate) oral solution Phase 3

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.


Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
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
Study Start Date : October 2004
Actual Primary Completion Date : September 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Club Drugs

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Drug: Xyrem (sodium oxybate) oral solution
    Xyrem (sodium oxybate) oral solution

Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Layout table for eligibility information
Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location information
Canada, Ontario
Brain and Sleep Diagnostic Centre
Toronto, Ontario, Canada, M8X 2W2
Sponsors and Collaborators
Jazz Pharmaceuticals
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for additonal 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 Posted: August 22, 2005    Key Record Dates
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:
Layout table for MeSH terms
Narcolepsy
Disorders of Excessive Somnolence
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Sodium Oxybate
 Pharmaceutical Solutions
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs