Clinical Trial: An Efficacy/Safety Study of Perampanel for Reducing Essential Tremor

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Double-Blind, Cross-Over, Placebo-Controlled Efficacy and Tolerability Study of Perampanel and Essential Tremor

Brief Summary: Obtain information on whether the medication Perampanel reduces tremor in people with essential tremor and is well-tolerated.

Detailed Summary: Please see descriptions in "Primary and Secondary Outcomes".
Sponsor: VA Greater Los Angeles Healthcare System

Current Primary Outcome:

  • Tremor reduction. TETRAS scale, performance sub scale. [ Time Frame: 40 weeks ]
    This scale evaluates tremor of various body parts during postures, movement and tasks. Items are scored from 0 to 4, with 4 representing highest severity. Maximum score is 64.
  • Tremor reduction. TETRAS scale. Activity of Daily Living subscale. [ Time Frame: 40 weeks ]
    The subject rates to what extent tremor affects activities in a 12-item, 0-to-4 scale. Maximum score is 48.
  • Tremor reduction. TETRAS scale. Subject Global Impression of Change. [ Time Frame: 40 weeks ]
    Subjects rate the degree of change from minus 3 to plus 3.
  • Tremor reduction. TETRAS scale. QUEST subscale (QUality of life in Essential Tremor). [ Time Frame: 40 weeks ]
    30-item questionnaire in which the subject rates on a 0 to 4 scale how much tremor affects aspects of life.
  • Safety. vitals; [ Time Frame: 40 weeks ]
    Weight (lbs), respiration rate (rps), heart rate (bps) and blood pressure (mmhg).
  • Tolerability. Adverse Events. [ Time Frame: 40 weeks ]
    At each clinic and phone visit, the PI and coordinator will collect information on any adverse events. An Adverse Event will be defined as any clinically undesirable event.
  • Safety; laboratory testing [ Time Frame: 40 weeks ]
    At each

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Treatment effects on Daily Living (The QUEST scale to assess quality of life) [ Time Frame: 40 weeks ]
      Assess the effect of treatment on tremor-affected activities of daily living. The QUEST scale to assess quality of life in essential tremor. It is a 30-item questionnaire in which the subject rates on a 0 to 4 scale how much tremor affects aspects of life
    • QOLIE changes [ Time Frame: 40 weeks ]
      Assess changes in Quality Of Life (QOLIE).
    • Subjective assessment of global life changes [ Time Frame: 40 weeks ]
      Assess subject global impression of change as a result of treatment


    Original Secondary Outcome: Same as current

    Information By: VA Greater Los Angeles Healthcare System

    Dates:
    Date Received: October 28, 2015
    Date Started: October 2015
    Date Completion: June 2017
    Last Updated: September 8, 2016
    Last Verified: September 2016