Essential TremorPhase 2NCT02668146
An Efficacy/Safety Study of Perampanel for Reducing Essential Tremor
A Phase 2 study testing Perampanel in people with Essential Tremor, run by VA Greater Los Angeles Healthcare System at 1 site in United States.
Trial summary
Obtain information on whether the medication Perampanel reduces tremor in people with essential tremor and is well-tolerated. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Essential Tremor
- What is being tested?
- Perampanel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Jun 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
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- 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
- -
Who cannot join
- 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
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- 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. -
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Greater Los Angeles
Los Angeles, California, 90073
About this study
Official title: A Double-Blind, Cross-Over, Placebo-Controlled Efficacy and Tolerability Study of Perampanel and Essential Tremor
Obtain information on whether the medication Perampanel reduces tremor in people with essential tremor and is well-tolerated.
Read the detailed description
Please see descriptions in "Primary and Secondary Outcomes".
- Conditions
- Essential Tremor
- Being tested
- Perampanel, Placebo
- Keywords
- essential tremor, Perampanel, clinical trial
- Medical subject headings
- Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PerampanelDrug
Study drug will be administered to study subjects
PlaceboDrug
Placebo will be administered to study subjects
| Study group | Role | What they receive |
|---|---|---|
| perampanel | Experimental | Perampanel administration Receives: Drug: Perampanel |
| placebo | Placebo comparator | Placebo administered to subjects. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 40 weeks
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.
Measured: 40 weeks
Tremor reduction. TETRAS scale. Subject Global Impression of Change.
Subjects rate the degree of change from minus 3 to plus 3.
Measured: 40 weeks
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.
Measured: 40 weeks
Safety. vitals;
Weight (lbs), respiration rate (rps), heart rate (bps) and blood pressure (mmhg).
Measured: 40 weeks
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.
Measured: 40 weeks
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.
Measured: 40 weeks
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.
Measured: screen visit
Secondary outcomes (3)
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
Measured: 40 weeks
QOLIE changes
Assess changes in Quality Of Life (QOLIE).
Measured: 40 weeks
Subjective assessment of global life changes
Assess subject global impression of change as a result of treatment
Measured: 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study startOct 2015
- Primary completionMar 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential TremorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Greater Los Angeles Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Adrian Handforth, MD, VA Greater Los Angeles Healthcare System
- Investigators
- Charles A Handforth, M.D., Principal investigator, VHAGLAHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02668146
- Sponsor's protocol ID
- 0042
- Status last verified
- Sep 2016
- First submitted
- 28 Oct 2015
- Last updated
- 12 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Cross-Over, Placebo-Controlled Efficacy and Tolerability Study of Perampanel and Essential Tremor
- ClinicalTrials.gov ID
- NCT02668146
- Acronym / sponsor ID
- 0042
- Conditions
- Essential Tremor
- Keywords
- essential tremor, Perampanel, clinical trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (actual)
- Lead sponsor
- VA Greater Los Angeles Healthcare SystemUS federal agency
- Study start
- Oct 2015
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 29 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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".
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| perampanel | Experimental | Drug: PerampanelPerampanel administration |
| placebo | Placebo comparator | Drug: PlaceboPlacebo administered to subjects. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PerampanelStudy drug will be administered to study subjects | Drug | perampanel |
| PlaceboPlacebo will be administered to study subjects | Drug | placebo |
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 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.
3 secondary outcomes
Treatment effects on Daily Living (The QUEST scale to assess quality of life)
Time frame: 40 weeks
QOLIE changes
Time frame: 40 weeks
Subjective assessment of global life changes
Time frame: 40 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles A Handforth, M.D. principal investigator
VHAGLAHS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Perampanel in people with Essential Tremor, run by VA Greater Los Angeles Healthcare System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tremor reduction. TETRAS scale, performance sub scale. (time frame: 40 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2016.