COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00598078
Recruitment Status : Completed
First Posted : January 18, 2008
Results First Posted : January 23, 2012
Last Update Posted : January 23, 2012
Information provided by (Responsible Party):
Jazz Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Essential Tremor Drug: Sodium Oxybate Other: Placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Multiple-dose, Double-blind, Placebo-controlled, Crossover Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Sodium Oxybate (Xyrem) in Subjects With Moderate to Severe Essential Tremor
Study Start Date : December 2007
Actual Primary Completion Date : August 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Club Drugs Tremor

Arm Intervention/treatment
Experimental: 1 Drug: Sodium Oxybate
Dose 1

Experimental: 2 Drug: Sodium Oxybate
Dose 2

Placebo Comparator: 3 Other: Placebo
Dose 3

Primary Outcome Measures :
  1. Modified FTM(Fahn-Tolosa-Marin) Essentials Tremor Rating Scale, Sum of All Essential Rating Tremor Scales Including Voice Tremor [ Time Frame: Hour 1 ]
    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).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00598078

Layout table for location information
United States, Michigan
Quest Research Institiute
Bingham Farms, Michigan, United States, 48025
Sponsors and Collaborators
Jazz Pharmaceuticals
Layout table for investigator information
Principal Investigator: Aaron Ellenbogen, DO Quest Research Institute
Layout table for additonal information
Responsible Party: Jazz Pharmaceuticals Identifier: NCT00598078    
Other Study ID Numbers: 06-015
First Posted: January 18, 2008    Key Record Dates
Results First Posted: January 23, 2012
Last Update Posted: January 23, 2012
Last Verified: December 2011
Additional relevant MeSH terms:
Layout table for MeSH terms
Essential Tremor
Neurologic Manifestations
Nervous System Diseases
Movement Disorders
Central Nervous System Diseases
Sodium Oxybate
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Central Nervous System Depressants
Physiological Effects of Drugs