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Trial Outcomes & Findings for Multiple-dose,Double-blind,Placebo-controlled Study of Sodium Oxybate in Patients With Essential Tremor (NCT NCT00598078)

NCT ID: NCT00598078

Last Updated: 2012-01-23

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

19 participants

Primary outcome timeframe

Hour 1

Results posted on

2012-01-23

Participant Flow

Participant milestones

Participant milestones
Measure
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;
Period 1 (Day 1)
STARTED
10
10
Period 1 (Day 1)
COMPLETED
10
10
Period 1 (Day 1)
NOT COMPLETED
0
0
Period 2 (Day 2)
STARTED
10
10
Period 2 (Day 2)
COMPLETED
9
10
Period 2 (Day 2)
NOT COMPLETED
1
0
Period 3 (Day 3)
STARTED
9
10
Period 3 (Day 3)
COMPLETED
9
10
Period 3 (Day 3)
NOT COMPLETED
0
0

Reasons for withdrawal

Reasons for withdrawal
Measure
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;
Period 2 (Day 2)
Adverse Event
1
0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
All Study Participants
n=20 Participants
All treated study participants
Age Continuous
60.0 years
STANDARD_DEVIATION 8.72 • n=5 Participants
Sex: Female, Male
Female
5 Participants
n=5 Participants
Sex: Female, Male
Male
15 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
1 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
Race (NIH/OMB)
White
19 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Region of Enrollment
United States
20 participants
n=5 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure
Sodium Oxybate 1.5 Grams (A)
n=20 Participants
Sodium Oxybate 0.75g at \~8am, Sodium Oxybate 0.75g at \~10am, placebo at \~12pm (Day 1 only)
Sodium Oxybate 3 Grams (B)
n=20 Participants
Sodium Oxybate 1.5g at \~8am, placebo at \~10am, Sodium Oxybate 1.5g at \~12pm (Day 2 or 3)
Placebo (C)
n=19 Participants
Placebo at \~8am, \~10am, and \~12pm (Day 2 or 3)
Modified FTM(Fahn-Tolosa-Marin) Essentials Tremor Rating Scale, Sum of All Essential Rating Tremor Scales Including Voice Tremor
13.4 Points
Interval 9.05 to 17.65
10.8 Points
Interval 6.5 to 15.1
13.0 Points
Interval 8.66 to 17.28

Adverse Events

Sodium Oxybate 1.5 Grams (A)

Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths

Sodium Oxybate 3 Grams (B)

Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths

Placebo (C)

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Sodium Oxybate 1.5 Grams (A)
n=20 participants at risk
Sodium Oxybate 0.75g at \~8am, Sodium Oxybate 0.75g at \~10am, placebo at \~12pm (Day 1 only)
Sodium Oxybate 3 Grams (B)
n=20 participants at risk
Sodium Oxybate 1.5g at \~8am, placebo at \~10am, Sodium Oxybate 1.5g at \~12pm (Day 2 or 3)
Placebo (C)
n=19 participants at risk
Placebo at \~8am, \~10am, and \~12pm (Day 2 or 3)
Nervous system disorders
Dizziness
5.0%
1/20 • Number of events 1
20.0%
4/20 • Number of events 4
0.00%
0/19
Nervous system disorders
Headache
10.0%
2/20 • Number of events 2
5.0%
1/20 • Number of events 3
0.00%
0/19
Nervous system disorders
Disturbance in Attention
0.00%
0/20
5.0%
1/20 • Number of events 1
0.00%
0/19
Nervous system disorders
Paraesthesia
0.00%
0/20
5.0%
1/20 • Number of events 1
0.00%
0/19
Nervous system disorders
Somnolence
0.00%
0/20
5.0%
1/20 • Number of events 1
0.00%
0/19
General disorders
Feeling Drunk
10.0%
2/20 • Number of events 2
25.0%
5/20 • Number of events 5
0.00%
0/19
General disorders
Chest Pain
5.0%
1/20 • Number of events 1
5.0%
1/20 • Number of events 1
0.00%
0/19
General disorders
Feeling Abnormal
0.00%
0/20
5.0%
1/20 • Number of events 1
0.00%
0/19
Psychiatric disorders
Disorientation
0.00%
0/20
5.0%
1/20 • Number of events 1
0.00%
0/19
Psychiatric disorders
Euphoric Mood
0.00%
0/20
5.0%
1/20 • Number of events 1
0.00%
0/19
Psychiatric disorders
Paranoia
0.00%
0/20
5.0%
1/20 • Number of events 1
0.00%
0/19
Psychiatric disorders
Tearfulness
0.00%
0/20
5.0%
1/20 • Number of events 1
0.00%
0/19
Eye disorders
Lacrimation Increased
0.00%
0/20
5.0%
1/20 • Number of events 1
5.3%
1/19 • Number of events 1
Gastrointestinal disorders
Nausea
5.0%
1/20 • Number of events 1
0.00%
0/20
0.00%
0/19

Additional Information

Grace Wang, MD Director Clinical Development and Medical Monitor

Jazz Pharmaceuticals

Phone: 650-496-3777

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: OTHER