NCT00132873

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2004

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 22, 2005

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
6 years until next milestone

Results Posted

Study results publicly available

November 25, 2013

Completed
Last Updated

November 25, 2013

Status Verified

September 1, 2013

Enrollment Period

2.9 years

First QC Date

August 18, 2005

Results QC Date

September 18, 2013

Last Update Submit

September 18, 2013

Conditions

Narcolepsy

Keywords

NarcolepsyCataplexy

Outcome Measures

Primary Outcomes (2)

  • Adverse Experiences

    Number of Subjects with treatment-emergent adverse events.

    continuous

  • Vital Signs

    Average Respiratory Rate at 1 year.

    At 1 year

Interventions

Xyrem (sodium oxybate) oral solutionDRUG

Xyrem (sodium oxybate) oral solution

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brain and Sleep Diagnostic Centre

Toronto, Ontario, M8X 2W2, Canada

Location

MeSH Terms

Conditions

NarcolepsyCataplexy

Interventions

Sodium OxybateSolutions

Condition Hierarchy (Ancestors)

Disorders of Excessive SomnolenceSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

HydroxybutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsPharmaceutical Preparations

Results Point of Contact

Title
Mortimer Mamelak, MD
Organization
Jazz Pharmaceuticals, Inc.
roman.skowronski@jazzpharma.com
650 496 3777

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 18, 2005

First Posted

August 22, 2005

Study Start

October 1, 2004

Primary Completion

September 1, 2007

Study Completion

December 1, 2007

Last Updated

November 25, 2013

Results First Posted

November 25, 2013

Record last verified: 2013-09

Locations

CA(1)