An Efficacy/Safety Study of Perampanel for Reducing Essential Tremor
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|ClinicalTrials.gov Identifier: NCT02668146|
Recruitment Status : Unknown
Verified September 2016 by Adrian Handforth, MD, VA Greater Los Angeles Healthcare System.
Recruitment status was: Active, not recruiting
First Posted : January 29, 2016
Last Update Posted : September 12, 2016
|Condition or disease||Intervention/treatment||Phase|
|Essential Tremor||Drug: Perampanel Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Double-Blind, Cross-Over, Placebo-Controlled Efficacy and Tolerability Study of Perampanel and Essential Tremor|
|Study Start Date :||October 2015|
|Estimated Primary Completion Date :||March 2017|
|Estimated Study Completion Date :||June 2017|
Study drug will be administered to study subjects
Placebo Comparator: placebo
Placebo administered to subjects.
Placebo will be administered to study subjects
- 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 clinic visit. Laboratory testing will be done. This will include metabolic panel (serum electrolytes, glucose (mg/dl) , creatinine (mg/dl) , calcium (mg/dl), magnesium (mg/dl), Complete Blood Count(CBC) (mg/dl), White Blood Count (WBC) (k/ul), platelets (k/ul), hepatic panel (total BILIRUBIN, Total PROTEIN, ALKALINE PHOSPHATASE, ALANINE AMINOTRANSFERASE, ASPARTATE AMINOTRANSFERASE, ALBUMIN GLUTAMYL TRANSFERASE LDH), and urinalysis.
- Safety. Laboratory testing; screen visit testing [ Time Frame: screen visit ]Screen Visit testing will include hemoglobin A1c (%), free thyroxin (ng/dl), and Thyroid Stimulating Hormone (TSH) (uIU/mL) . An EKG will be performed.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02668146
|United States, California|
|VA Greater Los Angeles|
|Los Angeles, California, United States, 90073|
|Principal Investigator:||Charles A Handforth, M.D.||VHAGLAHS|