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Completed

NCT Number: NCT00132873

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

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.

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Key information

Conditions

Narcolepsy Cataplexy Disorders of Excessive Somnolence Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Brain and Sleep Diagnostic Centre

Toronto, Ontario, M8X 2W2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Xyrem (sodium oxybate) oral solution

Drug

Xyrem (sodium oxybate) oral solution

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Jazz Pharmaceuticals

Industry

Registry information

Official study title

Long-Term, Open-Label, Multi-Center Extension Trial of Xyrem® (Sodium Oxybate) Oral Solution for the Treatment of Narcolepsy

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Aug 22, 2005
Registry last updated
Nov 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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