Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Obtain information on whether the medication Perampanel reduces tremor in people with essential tremor and is well-tolerated.
Please see descriptions in "Primary and Secondary Outcomes".
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| perampanel | Experimental | Perampanel administration |
|
| placebo | Placebo Comparator | Placebo administered to subjects. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perampanel | Drug | Study drug will be administered to study subjects |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 40 weeks |
| Tremor reduction. TETRAS scale. Subject Global Impression of Change. | Subjects rate the degree of change from minus 3 to plus 3. | 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. | 40 weeks |
| Safety. vitals; | Weight (lbs), respiration rate (rps), heart rate (bps) and blood pressure (mmhg). | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 40 weeks |
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Charles A Handforth, M.D. | VHAGLAHS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Greater Los Angeles | Los Angeles | California | 90073 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 5, 2025 | |
| Reset | Feb 27, 2025 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 5, 2025 | Feb 27, 2025 |
| ID | Term |
|---|---|
| D020329 | Essential Tremor |
| ID | Term |
|---|---|
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C551441 | perampanel |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
Placebo will be administered to study subjects |
|
| 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. | screen visit |
| QOLIE changes | Assess changes in Quality Of Life (QOLIE). | 40 weeks |
| Subjective assessment of global life changes | Assess subject global impression of change as a result of treatment | 40 weeks |