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
- Treatment effects on Daily Living (The QUEST scale to assess quality of life) [ Time Frame: 40 weeks ]