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

This study has been completed.
Information provided by (Responsible Party):
Jazz Pharmaceuticals Identifier:
First received: January 9, 2008
Last updated: December 15, 2011
Last verified: December 2011
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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

Further study details as provided by Jazz Pharmaceuticals:

Primary Outcome Measures:
  • Modified FTM(Fahn-Tolosa-Marin) Essentials Tremor Rating Scale, Sum of All Essential Rating Tremor Scales Including Voice Tremor [ Time Frame: Hour 1 ] [ Designated as safety issue: No ]
    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).

Enrollment: 19
Study Start Date: December 2007
Study Completion Date: December 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Sodium Oxybate
Dose 1
Experimental: 2 Drug: Sodium Oxybate
Dose 2
Placebo Comparator: 3 Other: Placebo
Dose 3


Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00598078

United States, Michigan
Quest Research Institiute
Bingham Farms, Michigan, United States, 48025
Sponsors and Collaborators
Jazz Pharmaceuticals
Principal Investigator: Aaron Ellenbogen, DO Quest Research Institute
  More Information

Responsible Party: Jazz Pharmaceuticals Identifier: NCT00598078     History of Changes
Other Study ID Numbers: 06-015 
Study First Received: January 9, 2008
Results First Received: September 13, 2011
Last Updated: December 15, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Essential Tremor
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Sodium Oxybate
Adjuvants, Anesthesia
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Depressants
Physiological Effects of Drugs processed this record on May 26, 2016