Multiple-dose,Double-blind,Placebo-controlled Study of Sodium Oxybate in Patients With Essential Tremor
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ClinicalTrials.gov Identifier: NCT00598078 |
Recruitment Status :
Completed
First Posted : January 18, 2008
Results First Posted : January 23, 2012
Last Update Posted : January 23, 2012
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Sponsor:
Jazz Pharmaceuticals
Information provided by (Responsible Party):
Jazz Pharmaceuticals
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Study Type | Interventional |
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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 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Regimen A, Then B, Then C | Regimen A, Then C, Then B |
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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 |
Baseline Characteristics
Arm/Group Title | All Study Participants | |
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All treated study participants | |
Overall Number of Baseline Participants | 20 | |
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[Not Specified]
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Age Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 20 participants | |
60.0 (8.72) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 20 participants | |
Female |
5 25.0%
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Male |
15 75.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 20 participants | |
American Indian or Alaska Native |
0 0.0%
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Asian |
1 5.0%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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Black or African American |
0 0.0%
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White |
19 95.0%
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More than one race |
0 0.0%
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Unknown or Not Reported |
0 0.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 20 participants |
20 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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 |
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 |