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An Efficacy/Safety Study of Perampanel for Reducing Essential Tremor

Primary Purpose

Essential Tremor

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Perampanel
Placebo
Sponsored by
VA Greater Los Angeles Healthcare System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Tremor focused on measuring essential tremor, Perampanel, clinical trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Subject has reviewed, signed and dated a written informed consent form and use of protected health information [Health Insurance Portability and Accountability Act (HIPAA) Authorization], including videotaping consent.
  2. Subject is 18 or older.
  3. Subject has a diagnosis of definite or probable essential tremor (ET) as defined by the Tremor Investigational Group, with involvement of the hands and arms of at least 2 years duration, without present causes of enhanced physiologic tremor, no recent exposure to tremorogenic drugs or drug withdrawal states, no direct or indirect trauma to the nervous system within 3 months preceding the onset of tremor, and no historic or clinical evidence of psychogenic tremor origin.
  4. Tremor severity score of at least 2 in at least one upper extremity on the Fahn-Tolosa-Marin Tremor Rating Scale, or at least 1.5 on the TETRAS scale.
  5. Subject is taking the same dose of one to three anti-tremor medications for at least 4 weeks prior to screening, has an inadequate response to that/those medication(s), and, barring any unforeseen circumstances, will continue for the duration of the study on the same dose(s) of anti-tremor medication(s), OR Has failed at least one course of an anti-tremor medication and cannot tolerate available anti-tremor medication(s), OR Is naive to anti-tremor treatment and refuses to take available anti-tremor medications.
  6. If a woman of childbearing potential:

    A. Must be unable to become pregnant or use adequate birth control; B. Must be defined as status post hysterectomy or tubal ligation, or 2 years post-menopausal, OR C. Otherwise documented to be incapable of pregnancy, or have practiced one of the following methods of contraception for at least two months prior to screening: 1) hormonal contraceptives, 2) spermicide and barrier method, 3) intrauterine device, 4) partner sterility, 5) abstinence, and have a negative pregnancy test during screening.

  7. Subject is accessible by telephone.
  8. Subject can comply with study visits, study drug compliance, and study procedures.
  9. Subject is on stable doses of all other medications for at least 4 weeks prior to the first baseline visit, and, barring any unforeseen circumstances, for the duration of the study

    -

Exclusion Criteria:

  1. Subject's tremor is adequately controlled on a current treatment.
  2. Subject is pregnant, plans to become pregnant during the study or within 2 months of completing the study or who is presently lactating or breast-feeding.
  3. Subject has other medical conditions that may cause or explain subject's tremor, such as but not limited to, Parkinson's disease, hyperthyroidism, pheochromocytoma, head trauma or cerebrovascular disease within 3 months prior to the onset of essential tremor; multiple sclerosis, polyneuropathy or family history of Fragile X syndrome.
  4. Subject taking medication(s) that might produce tremor or interfere with the evaluation of tremor, such as but not limited to: CNS-stimulants, stimulant decongestants, beta-agonist bronchodilators, lithium, amiodarone, metoclopramide, theophylline, valproate, Irregular use ("as needed" or "prn") of benzodiazepines, sleep medications or anxiolytics; (However, regular use of a benzodiazepine, sleep medication or anxiolytic to improve sleep or performance is allowed as long as tremor persists against the background of regular medication use)
  5. Subject has had surgical intervention for their tremor in the past (e.g., ablative thalamotomy or gamma knife thalamotomy), or has had a botulinum toxin injection in the 6 months prior to screening
  6. Subject has used an experimental drug within the 4 weeks prior to screening (or within 5 half-lives, whichever is longer) for any reason, OR has used a device for the treatment of essential tremor in the 4 weeks prior to screening, OR has ever used deep brain stimulation for any reason
  7. Subject cannot abstain from the use of the following drugs for the stated period of time prior to a clinic visit: caffeine (8 hours) and alcohol (12 hours).
  8. Subject cannot abstain from use of alcohol prior to driving vehicle or operating heavy machinery.
  9. Subject with a history in the last 2 years of alcohol or substance abuse (DSM 305); or history of consuming more than 2 glasses of wine (or equivalent) per day in the last 28 days prior to screening.
  10. Subject with a history of significant psychiatric disorder (e.g., mania, bipolar depressive disorder, schizophrenia, schizoaffective disorder, or other major psychiatric disorder), significant coagulation, immunologic, gastrointestinal, respiratory, cardiovascular (e.g., uncontrolled hypertension, myocardial infarction in the last 18 months, significant bundle branch block, congestive heart disease), endocrine (e.g., uncontrolled diabetes, hyperthyroidism) disorder, or current or chronic infection, significant Screening laboratory or ECG abnormalities, or any acute or chronic illness or abnormality which in the opinion of the Investigator precludes study participation. Subject with Right Bundle Branch Block, pacemakers, controlled asthma or controlled hypertension and/or controlled diabetes (hemoglobin A1c < 8%) are acceptable, as are subjects with thyroid disease, provided they are euthyroid on treatment. Subject with single or recurrent episodes of major depressive disorder (DSM IV 296.20 -.25 or 296.30-.35) that have been successfully managed with a stable dose (over 60 days) of an antidepressant may be considered for entry.
  11. Subject with liver disease that is more than mild. This is defined as transaminase levels AST and ALT greater than 50% above normal.
  12. Subject with severe renal disease, defined as having creatinine clearance less than 39 ml/min.
  13. Subject has had a suicide attempt, suicidal ideation with intent, or history of aggression, including but not restricted to violence or threat of violence, within the past 2 years.
  14. Subject with a recent history of hematologic/oncologic disorders (within 2 years), other than successfully resolved cutaneous basal cell or squamous cell carcinomas. Stability after treatment for prostate cancer is also acceptable.
  15. Subject with clinically significant impaired balance or considered at increased risk for falls.
  16. Subject is taking phenytoin, carbamazepine, oxycarbazine, rifampin, St John's wart, ketonazole or consuming grapefruit juice.
  17. Subject with history of taking perampanel in the past. -

Sites / Locations

  • VA Greater Los Angeles

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

perampanel

placebo

Arm Description

Perampanel administration

Placebo administered to subjects.

Outcomes

Primary Outcome Measures

Tremor reduction. TETRAS scale, performance sub scale.
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.
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.
Subjects rate the degree of change from minus 3 to plus 3.
Tremor reduction. TETRAS scale. QUEST subscale (QUality of life in Essential Tremor).
30-item questionnaire in which the subject rates on a 0 to 4 scale how much tremor affects aspects of life.
Safety. vitals;
Weight (lbs), respiration rate (rps), heart rate (bps) and blood pressure (mmhg).
Tolerability. Adverse Events.
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
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
Screen Visit testing will include hemoglobin A1c (%), free thyroxin (ng/dl), and Thyroid Stimulating Hormone (TSH) (uIU/mL) . An EKG will be performed.

Secondary Outcome Measures

Treatment effects on Daily Living (The QUEST scale to assess quality of life)
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
Assess changes in Quality Of Life (QOLIE).
Subjective assessment of global life changes
Assess subject global impression of change as a result of treatment

Full Information

First Posted
October 28, 2015
Last Updated
September 8, 2016
Sponsor
VA Greater Los Angeles Healthcare System
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1. Study Identification

Unique Protocol Identification Number
NCT02668146
Brief Title
An Efficacy/Safety Study of Perampanel for Reducing Essential Tremor
Official Title
A Double-Blind, Cross-Over, Placebo-Controlled Efficacy and Tolerability Study of Perampanel and Essential Tremor
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA Greater Los Angeles Healthcare System

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Obtain information on whether the medication Perampanel reduces tremor in people with essential tremor and is well-tolerated.
Detailed Description
Please see descriptions in "Primary and Secondary Outcomes".

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Tremor
Keywords
essential tremor, Perampanel, clinical trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
perampanel
Arm Type
Experimental
Arm Description
Perampanel administration
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered to subjects.
Intervention Type
Drug
Intervention Name(s)
Perampanel
Intervention Description
Study drug will be administered to study subjects
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will be administered to study subjects
Primary Outcome Measure Information:
Title
Tremor reduction. TETRAS scale, performance sub scale.
Description
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.
Time Frame
40 weeks
Title
Tremor reduction. TETRAS scale. Activity of Daily Living subscale.
Description
The subject rates to what extent tremor affects activities in a 12-item, 0-to-4 scale. Maximum score is 48.
Time Frame
40 weeks
Title
Tremor reduction. TETRAS scale. Subject Global Impression of Change.
Description
Subjects rate the degree of change from minus 3 to plus 3.
Time Frame
40 weeks
Title
Tremor reduction. TETRAS scale. QUEST subscale (QUality of life in Essential Tremor).
Description
30-item questionnaire in which the subject rates on a 0 to 4 scale how much tremor affects aspects of life.
Time Frame
40 weeks
Title
Safety. vitals;
Description
Weight (lbs), respiration rate (rps), heart rate (bps) and blood pressure (mmhg).
Time Frame
40 weeks
Title
Tolerability. Adverse Events.
Description
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.
Time Frame
40 weeks
Title
Safety; laboratory testing
Description
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.
Time Frame
40 weeks
Title
Safety. Laboratory testing; screen visit testing
Description
Screen Visit testing will include hemoglobin A1c (%), free thyroxin (ng/dl), and Thyroid Stimulating Hormone (TSH) (uIU/mL) . An EKG will be performed.
Time Frame
screen visit
Secondary Outcome Measure Information:
Title
Treatment effects on Daily Living (The QUEST scale to assess quality of life)
Description
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
Time Frame
40 weeks
Title
QOLIE changes
Description
Assess changes in Quality Of Life (QOLIE).
Time Frame
40 weeks
Title
Subjective assessment of global life changes
Description
Assess subject global impression of change as a result of treatment
Time Frame
40 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subject has reviewed, signed and dated a written informed consent form and use of protected health information [Health Insurance Portability and Accountability Act (HIPAA) Authorization], including videotaping consent. Subject is 18 or older. Subject has a diagnosis of definite or probable essential tremor (ET) as defined by the Tremor Investigational Group, with involvement of the hands and arms of at least 2 years duration, without present causes of enhanced physiologic tremor, no recent exposure to tremorogenic drugs or drug withdrawal states, no direct or indirect trauma to the nervous system within 3 months preceding the onset of tremor, and no historic or clinical evidence of psychogenic tremor origin. Tremor severity score of at least 2 in at least one upper extremity on the Fahn-Tolosa-Marin Tremor Rating Scale, or at least 1.5 on the TETRAS scale. Subject is taking the same dose of one to three anti-tremor medications for at least 4 weeks prior to screening, has an inadequate response to that/those medication(s), and, barring any unforeseen circumstances, will continue for the duration of the study on the same dose(s) of anti-tremor medication(s), OR Has failed at least one course of an anti-tremor medication and cannot tolerate available anti-tremor medication(s), OR Is naive to anti-tremor treatment and refuses to take available anti-tremor medications. If a woman of childbearing potential: A. Must be unable to become pregnant or use adequate birth control; B. Must be defined as status post hysterectomy or tubal ligation, or 2 years post-menopausal, OR C. Otherwise documented to be incapable of pregnancy, or have practiced one of the following methods of contraception for at least two months prior to screening: 1) hormonal contraceptives, 2) spermicide and barrier method, 3) intrauterine device, 4) partner sterility, 5) abstinence, and have a negative pregnancy test during screening. Subject is accessible by telephone. Subject can comply with study visits, study drug compliance, and study procedures. Subject is on stable doses of all other medications for at least 4 weeks prior to the first baseline visit, and, barring any unforeseen circumstances, for the duration of the study - Exclusion Criteria: Subject's tremor is adequately controlled on a current treatment. Subject is pregnant, plans to become pregnant during the study or within 2 months of completing the study or who is presently lactating or breast-feeding. Subject has other medical conditions that may cause or explain subject's tremor, such as but not limited to, Parkinson's disease, hyperthyroidism, pheochromocytoma, head trauma or cerebrovascular disease within 3 months prior to the onset of essential tremor; multiple sclerosis, polyneuropathy or family history of Fragile X syndrome. Subject taking medication(s) that might produce tremor or interfere with the evaluation of tremor, such as but not limited to: CNS-stimulants, stimulant decongestants, beta-agonist bronchodilators, lithium, amiodarone, metoclopramide, theophylline, valproate, Irregular use ("as needed" or "prn") of benzodiazepines, sleep medications or anxiolytics; (However, regular use of a benzodiazepine, sleep medication or anxiolytic to improve sleep or performance is allowed as long as tremor persists against the background of regular medication use) Subject has had surgical intervention for their tremor in the past (e.g., ablative thalamotomy or gamma knife thalamotomy), or has had a botulinum toxin injection in the 6 months prior to screening Subject has used an experimental drug within the 4 weeks prior to screening (or within 5 half-lives, whichever is longer) for any reason, OR has used a device for the treatment of essential tremor in the 4 weeks prior to screening, OR has ever used deep brain stimulation for any reason Subject cannot abstain from the use of the following drugs for the stated period of time prior to a clinic visit: caffeine (8 hours) and alcohol (12 hours). Subject cannot abstain from use of alcohol prior to driving vehicle or operating heavy machinery. Subject with a history in the last 2 years of alcohol or substance abuse (DSM 305); or history of consuming more than 2 glasses of wine (or equivalent) per day in the last 28 days prior to screening. Subject with a history of significant psychiatric disorder (e.g., mania, bipolar depressive disorder, schizophrenia, schizoaffective disorder, or other major psychiatric disorder), significant coagulation, immunologic, gastrointestinal, respiratory, cardiovascular (e.g., uncontrolled hypertension, myocardial infarction in the last 18 months, significant bundle branch block, congestive heart disease), endocrine (e.g., uncontrolled diabetes, hyperthyroidism) disorder, or current or chronic infection, significant Screening laboratory or ECG abnormalities, or any acute or chronic illness or abnormality which in the opinion of the Investigator precludes study participation. Subject with Right Bundle Branch Block, pacemakers, controlled asthma or controlled hypertension and/or controlled diabetes (hemoglobin A1c < 8%) are acceptable, as are subjects with thyroid disease, provided they are euthyroid on treatment. Subject with single or recurrent episodes of major depressive disorder (DSM IV 296.20 -.25 or 296.30-.35) that have been successfully managed with a stable dose (over 60 days) of an antidepressant may be considered for entry. Subject with liver disease that is more than mild. This is defined as transaminase levels AST and ALT greater than 50% above normal. Subject with severe renal disease, defined as having creatinine clearance less than 39 ml/min. Subject has had a suicide attempt, suicidal ideation with intent, or history of aggression, including but not restricted to violence or threat of violence, within the past 2 years. Subject with a recent history of hematologic/oncologic disorders (within 2 years), other than successfully resolved cutaneous basal cell or squamous cell carcinomas. Stability after treatment for prostate cancer is also acceptable. Subject with clinically significant impaired balance or considered at increased risk for falls. Subject is taking phenytoin, carbamazepine, oxycarbazine, rifampin, St John's wart, ketonazole or consuming grapefruit juice. Subject with history of taking perampanel in the past. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles A Handforth, M.D.
Organizational Affiliation
VHAGLAHS
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Greater Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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An Efficacy/Safety Study of Perampanel for Reducing Essential Tremor

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