NCT00598078

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

Multiple-dose, Double-blind, Placebo-controlled, Crossover Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Sodium Oxybate (Xyrem) in Subjects With Moderate to Severe Essential Tremor

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Essential Tremor

Interventions

Type	Name	Description
DRUG	Sodium Oxybate	Dose 1
DRUG	Sodium Oxybate	Dose 2
OTHER	Placebo	Dose 3

Timeline

• Start date: 2007-12-01
• Primary completion: 2008-08-01
• Completion: 2008-12-01
• First posted: 2008-01-18
• Last updated: 2012-01-23
• Results posted: 2012-01-23

Locations

1 site across 1 country: United States