Trial record 15 of 70 for:    Narcolepsy

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

This study has been completed.
Sponsor:
Information provided by:
Jazz Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00132873
First received: August 18, 2005
Last updated: September 18, 2013
Last verified: September 2013
  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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]
    Number of Subjects with treatment-emergent adverse events.

  • Vital Signs [ Time Frame: At 1 year ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00132873

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

No publications provided

Responsible Party: Senir Director, Clinical Development - Psychiatry, Jazz Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT00132873     History of Changes
Other Study ID Numbers: OMC-SXB-27
Study First Received: August 18, 2005
Results First Received: September 18, 2013
Last Updated: September 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Jazz Pharmaceuticals:
Narcolepsy
Cataplexy

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

ClinicalTrials.gov processed this record on October 20, 2014