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

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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

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 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


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


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.



Information from the National Library of Medicine

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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

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

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:
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