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

NCT00598078 | Completed Phase 2 Results

• 1 other identifier: 06-015
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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

Conditions

Essential Tremor

Outcome Measures

Primary Outcomes (1)

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

  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).

  Hour 1

Study Arms (3)

1

EXPERIMENTAL

Drug: Sodium Oxybate

2

EXPERIMENTAL

Drug: Sodium Oxybate

3

PLACEBO COMPARATOR

Other: Placebo

Interventions

Sodium Oxybate DRUG

Dose 1

1

Placebo OTHER

Dose 3

3

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jazz Pharmaceuticals: lead

Study Sites (1)

Quest Research Institiute

Bingham Farms, Michigan, 48025, United States

Location

MeSH Terms

Conditions

Essential Tremor

Interventions

Sodium Oxybate

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Hydroxybutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids

Results Point of Contact

• Title: Grace Wang, MD Director Clinical Development and Medical Monitor
• Organization: Jazz Pharmaceuticals

650-496-3777

Study Officials

• Aaron Ellenbogen, DO

  Quest Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2008
• First Posted: January 18, 2008
• Study Start: December 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: December 1, 2008
• Last Updated: January 23, 2012
• Results First Posted: January 23, 2012

Record last verified: 2011-12

Locations

US (1)