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

Jazz Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Essential Tremor

Treatments: Other: Placebo; Drug: Sodium Oxybate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00598078

06-015

Details and patient eligibility

About

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

Enrollment: 19 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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19 participants in 3 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: Sodium Oxybate

Drug: Sodium Oxybate

2

Experimental group

Treatment:

Drug: Sodium Oxybate

Drug: Sodium Oxybate

3

Placebo Comparator group

Treatment:

Other: Placebo