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

Jazz Pharmaceuticals19 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Essential Tremor

Interventions

Sodium OxybateDRUG

Dose 1

Sodium OxybateDRUG

Dose 2

PlaceboOTHER

Dose 3

Eligibility

Sex: ALLMin age: 50 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Quest Research Institiute

Bingham Farms, Michigan, United States

Outcomes

Primary Outcomes

Modified FTM(Fahn-Tolosa-Marin) Essentials Tremor Rating Scale, Sum of All Essential Rating Tremor Scales Including Voice Tremor

The modified FTM sum of all essential rating tremor scales including voice tremor includes: the tremor rating taken for the left \& right hands individually at rest, with posture (arms outstretched), with action (finger to nose). It also includes an evaluation of voice with scores for AAA \& EEE sounds, an action evaluation of left \& right hands pouring, bringing liquids to mouth, drawing large \& small spirals. Scores for indiviuals items range from 0 (no tremor) to 4 (severe tremor). The sum ranges from 0 (no tremor) to 72 points (higher amplitude/more tremors).

Time frame: Hour 1

Data from ClinicalTrials.gov

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