Not Signed In -
Pseudoephedrine and Guaifenesin Oral Solution |
Guaifed Syrup; Guiatuss PE Liquid; Robafen PE Liquid; Robitussin PE Liquid |
Clinical Trial: Trial of Xyrem® (Sodium Oxybate) for the Treatment of Narcolepsy
This study is currently recruiting patients.
Verified by Orphan Medical August 2005
|
Purpose
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: Sleep Disorders
Study Type: Interventional
Study Design: Educational/Counseling/Training, 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
Expected Total Enrollment: 70
Study start: October 2004; Expected completion: December 2005
Last follow-up: December 2005; Data entry closure: December 2005
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
Inclusion Criteria:
- Remained on satisfactory treatment with Xyrem® therapy in the OMC-SXB-7 trial
- Signed and dated an informed consent
Exclusion Criteria:
-
Location and Contact Information
Canada, Ontario
Brain and Sleep Diagnostic Centre, Toronto, Ontario, M8X 2W2, Canada; Recruiting
More Information
Last Updated: August 19, 2005
Record first received: August 18, 2005
ClinicalTrials.gov Identifier: NCT00132873
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-23
Resources
- Pseudoephedrine and Guaifenesin Oral Solution (Drug Digest)
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