At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 25 enrolled
Drug / intervention
Sodium Oxybate (Xyrem)drug
Likely dose
Sodium Oxybate (Xyrem) 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Single Center, Therapeutic Exploratory Clinical Trial to Evaluate the Safety of Sodium Oxybate (Xyrem) 500 mg/mL Oral Solution on Potential Endocrine Changes at Currently Labeled Therapeutic Dose Regimens (4.5 - 9 g/Day Divided Into Two Equal Doses) During 12 Weeks of Treatment of Cataplexy in Adult Patients With Narcolepsy.
In Brief
A Phase 1 clinical trial evaluating Sodium Oxybate (Xyrem) for Narcolepsy With Cataplexy. Completed, enrolled 25 participants across 1 site.
Detailed Summary
To monitor for endocrine changes in response to treatment of cataplexy with Xyrem, to focus on the hypothalamic pituitary axis and to confirm the safety of Xyrem on potential endocrine changes.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNarcolepsy With Cataplexy
CountriesBelgium
Collaborators--
Timeline
Phase 1CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2006
First PostedJun 2006
Primary CompletionJan 2008
TodayJul 2026
First PostedJun 29, 2006
Enrollment StartApr 10, 2006
Primary CompletionJan 22, 2008
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 20.0 years ago
Interventions
Sodium Oxybate (Xyrem)drug
* Active Substance: Sodium Oxybate * Pharmaceutical form: Oral Solution * Concentration: 500 mg/mL oral solution from 4.5 to 9 g/day divided into two equal doses during 12 weeks * Route of administration: Oral