drugset / Trial / NCT00598078

Multiple-dose,Double-blind,Placebo-controlled Study of Sodium Oxybate in Patients With Essential Tremor

NCT00598078 ↗

Phase 2 Completed 19 enrolled Jazz Pharmaceuticals
RandomizedCrossoverDouble-blindTreatment

Summary

To determine the relationship between drug plasma levels and safety, tolerability and efficacy in patients with essential tremors after dosing with Sodium oxybate

Timeline

Start
2007-12
Primary completion
2008-08
Completion
2008-12

Outcome

Met primary endpoint

registry analysis (superiority or other test); Sodium Oxybate 3 Grams (B) vs Placebo (C); p = 0.038; ANOVA NCT00598078 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Sodium Oxybate Unknown — —

Indications