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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2008-12-31

Brief Summary

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

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Detailed Description

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Conditions

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Essential Tremor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

Sodium Oxybate

Intervention Type DRUG

Dose 1

2

Group Type EXPERIMENTAL

Sodium Oxybate

Intervention Type DRUG

Dose 2

3

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Dose 3

Interventions

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Sodium Oxybate

Dose 1

Intervention Type DRUG

Sodium Oxybate

Dose 2

Intervention Type DRUG

Placebo

Dose 3

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No