We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov 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.
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):

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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Regimen A, Then B, Then C 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
Regimen A, Then C, Then B 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;

Participant Flow for 3 periods

Period 1:   Period 1 (Day 1)
    Regimen A, Then B, Then C   Regimen A, Then C, Then B
STARTED   10   10 
COMPLETED   10   10 
NOT COMPLETED   0   0 

Period 2:   Period 2 (Day 2)
    Regimen A, Then B, Then C   Regimen A, Then C, Then B
STARTED   10   10 
COMPLETED   9   10 
NOT COMPLETED   1   0 
Adverse Event                1                0 

Period 3:   Period 3 (Day 3)
    Regimen A, Then B, Then C   Regimen A, Then C, Then B
STARTED   9   10 
COMPLETED   9   10 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
All Study Participants All treated study participants

Baseline Measures
   All Study Participants 
Overall Participants Analyzed 
[Units: Participants]
 20 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.0  (8.72) 
Gender 
[Units: Participants]
 
Female   5 
Male   15 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   0 
Asian   1 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   0 
White   19 
More than one race   0 
Unknown or Not Reported   0 
Region of Enrollment 
[Units: Participants]
 
United States   20 


  Outcome Measures

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Grace Wang, MD Director Clinical Development and Medical Monitor
Organization: Jazz Pharmaceuticals
phone: 650-496-3777



Responsible Party: Jazz Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00598078     History of Changes
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