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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2007-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Narcolepsy

Keywords

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Narcolepsy Cataplexy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Interventions

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Xyrem (sodium oxybate) oral solution

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Jazz Pharmaceuticals, Inc

Locations

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Brain and Sleep Diagnostic Centre

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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OMC-SXB-27

Identifier Type: -

Identifier Source: org_study_id