CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
sodium oxybatedrug
Likely dose
Not stated in 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.

Search/NCT00641186
NCT00641186Phase 2Completed
CompareCT.gov

A Phase II, Eight Week, Multi-Center, Open Label Trial of Xyrem(R) (Sodium Oxybate) for Excessive Daytime Sleepiness and Nocturnal Sleep Disturbance in Patients With Mild to Moderate Parkinson's Disease

Baylor College of Medicine·interventional·Posted Mar 24, 2008·Updated Oct 6, 2022

In Brief

A Phase 2 clinical trial evaluating sodium oxybate for Parkinson Disease. Completed, enrolled 30 participants.

Detailed Summary

This clinical trial is designed to evaluate the safety and potential efficacy of Xyrem for the treatment of excessive daytime sleepiness (EDS) and nocturnal sleep disturbance in patients with mild to moderate Parkinson's Disease (PD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson Disease
Countries--
CollaboratorsJazz Pharmaceuticals

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 24, 2008
Enrollment StartSep 1, 2004
Primary CompletionJul 1, 2008
Study CompletionNov 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 18.3 years ago

Interventions

sodium oxybatedrug

4.5 to 9.0 grams per night