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

GHB

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

Intervention / Treatment

  • Sodium Oxybate (DRUG)
    Dose 2
  • Placebo (OTHER)
    Dose 3

Condition or Disease

  • Essential Tremor

Phase

  • Phase 2

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 50 Years to 75 Years
    Enrollment: 19 (ACTUAL)
    Funded by: Industry
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    DOUBLE:
    • Participant
    • Investigator

    Clinical Trial Dates

    Start date: Dec 01, 2007
    Primary Completion: Aug 01, 2008 ACTUAL
    Completion Date: Dec 01, 2008 ACTUAL
    Study First Posted: Jan 18, 2008 ESTIMATED
    Results First Posted: Jan 23, 2012 ESTIMATED
    Last Updated: Dec 15, 2011

    Sponsors / Collaborators

    Lead Sponsor: Jazz Pharmaceuticals
    Lead sponsor is responsible party
    Responsible Party: N/A

    Location

    Bingham Farms, Michigan, USA

    Participant Groups

    • No description provided

    • No description provided

    • No description provided

    Eligibility Criteria

    Sex: All
    Minimum Age: 50
    Maximum Age: 75
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes

    • 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).

    More Details

    NCT Number: NCT00598078
    Other IDs: 06-015
    Study URL: https://clinicaltrials.gov/study/NCT00598078
    Last updated: Sep 29, 2023