Multiple-Dose,Double-Blind,Placebo-Controlled Study of Sodium Oxybate in Patients With Essential Tremor

This study is currently recruiting participants.

Verified by Jazz Pharmaceuticals, June 2008

Sponsored by:	Jazz Pharmaceuticals
Information provided by:	Jazz Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00598078

Purpose

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

Condition	Intervention	Phase
Essential Tremor	Drug: Sodium Oxybate Other: Placebo	Phase II

Genetics Home Reference related topics: essential tremor familial paroxysmal nonkinesigenic dyskinesia

MedlinePlus related topics: Club Drugs Tremor

Drug Information available for: Sodium oxybate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment

Further study details as provided by Jazz Pharmaceuticals:

Primary Outcome Measures:

Comparison of plasma concentration and pharmacokinetic parameters following dosing [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine the efficacy and pharmacodynamics associated with dosing of study drug [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	December 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Sodium Oxybate Dose 1
2: Experimental	Drug: Sodium Oxybate Dose 2
3: Placebo Comparator	Other: Placebo Dose 3

Eligibility

Ages Eligible for Study:	50 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00598078

Contacts

Contact: Dolly Niles

248-644-7770

Locations

United States, Michigan
Quest Research Institiute	Recruiting
Bingham Farms, Michigan, United States, 48025
Principal Investigator: Aaron Ellenbogen, DO

Sponsors and Collaborators

Jazz Pharmaceuticals

Investigators

Principal Investigator:

Aaron Ellenbogen, DO

Quest Research Institute

More Information

Responsible Party:	Jazz Pharmaceuticals ( Director, Transitional Medicine )
Study ID Numbers:	06-015
Study First Received:	January 9, 2008
Last Updated:	June 16, 2008
ClinicalTrials.gov Identifier:	NCT00598078
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Signs and Symptoms
Essential Tremor
Movement Disorders
Benign essential tremor syndrome
Central Nervous System Diseases

Neurologic Manifestations
Dyskinesias
Tremor
Sodium Oxybate

Additional relevant MeSH terms:

Anesthetics, Intravenous
Adjuvants, Anesthesia
Anesthetics, General
Therapeutic Uses
Physiological Effects of Drugs

Nervous System Diseases
Central Nervous System Depressants
Anesthetics
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009