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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.
 
ClinicalTrials.gov Identifier: NCT00598078
Recruitment Status : Completed
First Posted : January 18, 2008
Results First Posted : January 23, 2012
Last Update Posted : January 23, 2012
Sponsor:
Information provided by (Responsible Party):
Jazz Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Essential Tremor
Interventions Drug: Sodium Oxybate
Other: Placebo
Enrollment 19
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Regimen A, Then B, Then C Regimen A, Then C, Then B
Hide Arm/Group Description Day 1: Sodium Oxybate 0.75g at ~8am, Sodium Oxybate 0.75g at ~10am, placebo at ~12pm; Day 2:Sodium Oxybate 1.5g at ~8am, placebo at ~10am, Sodium Oxybate 1.5g at ~12pm; Day 3:Placebo at ~8am, ~10am, and ~12pm Day 1: Sodium Oxybate 0.75g at ~8am, Sodium Oxybate 0.75g at ~10am, placebo at ~12pm; Day 2: Placebo at ~8am, ~10am, and ~12pm; Day 3: Sodium Oxybate 1.5g at ~8am, placebo at ~10am, Sodium Oxybate 1.5g at ~12pm;
Period Title: Period 1 (Day 1)
Started 10 10
Completed 10 10
Not Completed 0 0
Period Title: Period 2 (Day 2)
Started 10 10
Completed 9 10
Not Completed 1 0
Reason Not Completed
Adverse Event             1             0
Period Title: Period 3 (Day 3)
Started 9 10
Completed 9 10
Not Completed 0 0
Arm/Group Title All Study Participants
Hide Arm/Group Description All treated study participants
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
60.0  (8.72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
5
  25.0%
Male
15
  75.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   5.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
19
  95.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants
20
1.Primary Outcome
Title Modified FTM(Fahn-Tolosa-Marin) Essentials Tremor Rating Scale, Sum of All Essential Rating Tremor Scales Including Voice Tremor
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sodium Oxybate 1.5 Grams (A) Sodium Oxybate 3 Grams (B) Placebo (C)
Hide Arm/Group Description:
Sodium Oxybate 0.75g at ~8am, Sodium Oxybate 0.75g at ~10am, placebo at ~12pm (Day 1 only)
Sodium Oxybate 1.5g at ~8am, placebo at ~10am, Sodium Oxybate 1.5g at ~12pm (Day 2 or 3)
Placebo at ~8am, ~10am, and ~12pm (Day 2 or 3)
Overall Number of Participants Analyzed 20 20 19
Least Squares Mean (90% Confidence Interval)
Unit of Measure: Points
13.4
(9.05 to 17.65)
10.8
(6.50 to 15.10)
13.0
(8.66 to 17.28)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sodium Oxybate 1.5 Grams (A), Sodium Oxybate 3 Grams (B)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.013
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sodium Oxybate 1.5 Grams (A), Placebo (C)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.713
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Sodium Oxybate 3 Grams (B), Placebo (C)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.038
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sodium Oxybate 1.5 Grams (A) Sodium Oxybate 3 Grams (B) Placebo (C)
Hide Arm/Group Description Sodium Oxybate 0.75g at ~8am, Sodium Oxybate 0.75g at ~10am, placebo at ~12pm (Day 1 only) Sodium Oxybate 1.5g at ~8am, placebo at ~10am, Sodium Oxybate 1.5g at ~12pm (Day 2 or 3) Placebo at ~8am, ~10am, and ~12pm (Day 2 or 3)
All-Cause Mortality
Sodium Oxybate 1.5 Grams (A) Sodium Oxybate 3 Grams (B) Placebo (C)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Sodium Oxybate 1.5 Grams (A) Sodium Oxybate 3 Grams (B) Placebo (C)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/20 (0.00%)      0/19 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sodium Oxybate 1.5 Grams (A) Sodium Oxybate 3 Grams (B) Placebo (C)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/20 (25.00%)      12/20 (60.00%)      1/19 (5.26%)    
Eye disorders       
Lacrimation Increased * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 1/19 (5.26%)  1
Gastrointestinal disorders       
Nausea * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/19 (0.00%)  0
General disorders       
Feeling Drunk * 1  2/20 (10.00%)  2 5/20 (25.00%)  5 0/19 (0.00%)  0
Chest Pain * 1  1/20 (5.00%)  1 1/20 (5.00%)  1 0/19 (0.00%)  0
Feeling Abnormal * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/19 (0.00%)  0
Nervous system disorders       
Dizziness * 1  1/20 (5.00%)  1 4/20 (20.00%)  4 0/19 (0.00%)  0
Headache * 1  2/20 (10.00%)  2 1/20 (5.00%)  3 0/19 (0.00%)  0
Disturbance in Attention * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/19 (0.00%)  0
Paraesthesia * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/19 (0.00%)  0
Somnolence * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/19 (0.00%)  0
Psychiatric disorders       
Disorientation * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/19 (0.00%)  0
Euphoric Mood * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/19 (0.00%)  0
Paranoia * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/19 (0.00%)  0
Tearfulness * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/19 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.0)
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Grace Wang, MD Director Clinical Development and Medical Monitor
Organization: Jazz Pharmaceuticals
Phone: 650-496-3777
Layout table for additonal information
Responsible Party: Jazz Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00598078    
Other Study ID Numbers: 06-015
First Submitted: January 9, 2008
First Posted: January 18, 2008
Results First Submitted: September 13, 2011
Results First Posted: January 23, 2012
Last Update Posted: January 23, 2012