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

September 18, 2013 updated by: Jazz Pharmaceuticals

Long-Term, Open-Label, Multi-Center Extension Trial of Xyrem® (Sodium Oxybate) Oral Solution 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.

Study Overview

Status

Completed

Conditions

Narcolepsy

Intervention / Treatment

Drug: 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.

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- Ontario
  - Toronto, Ontario, Canada, M8X 2W2
    - Brain and Sleep Diagnostic Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Experiences Time Frame: continuous	Number of Subjects with treatment-emergent adverse events.	continuous
Vital Signs Time Frame: At 1 year	Average Respiratory Rate at 1 year.	At 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jazz Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

August 18, 2005

First Submitted That Met QC Criteria