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

Completed · Phase 2 · Has a placebo group

Conditions studied: Essential Tremor

In brief

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

Key facts

Study ID

NCT00598078

Run by

Jazz Pharmaceuticals

People needed

19

Starts

2007-12-01

Expected to finish

2008-12-01

Last updated by the study team

2012-01-23

Who can join

Age: 50 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of moderate or severe classic essential tremor (bilateral, largely symmetric postural or kinetic tremor involving hands and forearms.
• Willingness to abstain from ethanol and caffeine intake for at least 48 hours prior to Days 1 and 4 and on inpatient days

You may not qualify if…

• Subjects with a clinically significant unstable medical abnormality, chronic disease or history or presence of significant hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, psychiatric, or metabolic disease or any other abnormality
• Subjects who are on sodium-restricted diets
• Subjects with a known history of sleep apnea

Where it is running

• Quest Research Institiute — Bingham Farms, Michigan, United States

Full record on ClinicalTrials.gov

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