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

Phase 2

Completed

• Conditions: Essential Tremor
• Interventions: Other: Placebo; Drug: Sodium Oxybate

• Registration Number: NCT00598078
• Lead Sponsor: Jazz Pharmaceuticals

Brief Summary

To determine the relationship between drug plasma levels and safety, tolerability and efficacy in patients with essential tremors after dosing with Sodium oxybate

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2008-01-09
• Study First Submitted QC: 2008-01-09
• Study First Posted: 2008-01-18
• Primary Completion: 2008-08
• Study Completion: 2008-12
• Results First Submitted: 2011-09-13
• Status Verified: 2011-12
• Results First Submitted QC: 2011-12-15
• Last Update Submitted: 2011-12-15
• Results First Posted: 2012-01-23
• Last Update Posted: 2012-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
3	Placebo	-
2	Sodium Oxybate	-
1	Sodium Oxybate	-

Primary Outcome Measures

Name	Time	Method
Modified FTM(Fahn-Tolosa-Marin) Essentials Tremor Rating Scale, Sum of All Essential Rating Tremor Scales Including Voice Tremor	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).

Trial Locations

Locations (1)

Quest Research Institiute; 🇺🇸 Bingham Farms, Michigan, United States