Trial of Xyrem® (Sodium Oxybate) for the Treatment of Narcolepsy - Full Text View

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 III

MedlinePlus related topics:

Club Drugs

Drug Information available for:

Sodium oxybate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Other, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

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

Further study details as provided by Orphan Medical:

Primary Outcome Measures:

Adverse experiences [ Time Frame: continuous ] [ Designated as safety issue: Yes ]
Vital signs [ Time Frame: throughout trial ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	70
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:

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

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

Orphan Medical

More Information

Responsible Party:	Jazz Pharmaceuticals, Inc ( Senir Director, Clinical Development - Psychiatry )
Study ID Numbers:	OMC-SXB-27
First Received:	August 18, 2005
Last Updated:	September 9, 2008
ClinicalTrials.gov Identifier:	NCT00132873
Health Authority:	United States: Food and Drug Administration

Keywords provided by Orphan Medical:

Narcolepsy

Cataplexy

Study placed in the following topic categories:

Cataplexy

Mental Disorders

Narcolepsy

Dyssomnias

Sleep Disorders

Disorders of Excessive Somnolence

Sodium Oxybate

Gelineau's syndrome

Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Anesthetics, Intravenous

Adjuvants, Anesthesia

Anesthetics, General

Therapeutic Uses

Physiological Effects of Drugs

Nervous System Diseases

Central Nervous System Depressants

Anesthetics

Central Nervous System Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 05, 2008

Sponsored by:	Orphan Medical
Information provided by:	Orphan Medical
ClinicalTrials.gov Identifier:	NCT00132873