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Study sponsor no longer provided funding.
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| Name | Class |
|---|---|
| Eisai Inc. | INDUSTRY |
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The objective of this study is to determine whether there are any differences in the cognitive abilities and/or behavioral response of normal healthy volunteers across different titration rates of perampanel.
This is a randomized, double-blind, parallel group design across different titration rates of perampanel in healthy volunteers. The study consists of 8 visits, 4 of which will occur at the participant's home, over a 7-week period. One hundred and three (103) normal healthy subjects will be treated with perampanel (PER) at one of four different titration rates: (1) 2mg/day PER for one week followed by 4mg/day PER for five weeks, (2) 2mg/day PER for two weeks followed by 4mg/day PER for four weeks, (3) 4mg/day PER for six weeks, or (4) placebo (0mg/day PER) for six weeks. Cognitive and behavioral function testing along with safety testing will be conducted at screening, pretreatment baseline, the end of each week during the titration and maintenance period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants will take 2mg placebo PO QD for six weeks. |
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| PER 1 Week Titration | Experimental | Participants will take 2mg perampanel PO QD for one week, followed by 4mg perampanel PO QD for five weeks. |
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| PER 2 Week Titration | Experimental | Participants will take 2mg perampanel PO QD for two weeks, followed by 4mg perampanel PO QD for four weeks. |
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| PER 4 mg | Experimental | Participants will take 4mg perampanel PO QD for six weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perampanel 1 week titration | Drug | Healthy adults will take 2mg perampanel PO QD for one week followed 4mg perampanel PO QD for five weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Neuropsychological Composite Z-score as a Measure of Direct Comparison of the 4 Titration Conditions Across 6 Weeks of Treatment. | Z score of cognitive tests (selected performance measures from the computerized cognitive test battery) and questionnaires (AEP, POMS, QOLIE-cognitive questions) at the end of each week of drug treatment for each titration arm, controlling for baseline measures collected prior to treatment. Various measures were combined collectively (averaged) to compute an overall Z-score for each group at each time point. These included: 1) Executive Function Score of computerized test battery; 2) Processing Speed Score of computerized test battery; 3) AEP total score; 4) POMS total and domain scores; 5) Three cognitive components of the QOLIE-31 (attention, memory, language). The Z-score indicates the number of standard deviations away from a reference population. A Z-score of 0 is equal to the mean. Negative numbers indicate poorer performance compared to the mean and positive numbers represent higher performance compared to the mean. | At the end of each week of treatment for 6 weeks. |
| Composite Z-score of Objective Measures as a Measure of Direct Comparison of the 4 Titration Conditions Across 6 Weeks of Treatment. | Z score of objective cognitive tests (selected performance measures from the computerized cognitive test battery) at the end of each week of drug treatment for each titration arm, controlling for baseline measures collected prior to treatment. The Z-score indicates the number of standard deviations away from a reference population. A Z-score of 0 is equal to the mean. Negative numbers indicate poorer performance compared to the mean and positive numbers represent higher performance compared to the mean. | At the end of each week of treatment for 6 weeks. |
| Composite Z-score of Subjective Measures as a Measure of Direct Comparison of the 4 Titration Conditions Across 6 Weeks of Treatment. | Z score of subjective questionnaires (AEP, POMS, QOLIE-cognitive questions at the end of each week of drug treatment for each titration arm, controlling for baseline measures collected prior to treatment. Various measures were combined collectively (averaged) to compute an overall Z-score for each group at each time point. These included: 1) AEP total score; 2) POMS total and domain scores; 3) Three cognitive components of the QOLIE-31 (attention, memory, language). The Z-score indicates the number of standard deviations away from a reference population. A Z-score of 0 is equal to the mean. Negative numbers indicate poorer performance compared to the mean and positive numbers represent higher performance compared to the mean. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Emergent Adverse Events (TEAEs) Across the Six-week Treatment Period Measure of Direct Comparison of the 4 Titration Conditions Across 6 Weeks of Treatment. | Number of TEAEs across the the four titration conditions over the six-week treatment period. A score of 0 indicates no TEAEs. Higher numbers indicate greater TEAEs. | At the end of each week of treatment for 6 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kimford Meador, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94304 | United States | ||
| Northwestern University |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants take 2mg placebo PO QD for six weeks. |
| FG001 | PER 1 Week Titration | Participants take 2mg perampanel PO QD for one week and 4mg perampanel PO QD for five weeks. |
| FG002 | PER 2 Week Titration | Participants take 2mg perampanel PO QD for two weeks and 4mg perampanel PO QD for four weeks. |
| FG003 | PER 4 mg | Participants take 4mg perampanel PO QD for six weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants take 2mg placebo PO QD for six weeks. |
| BG001 | PER 1 Week Titration | Participants take 2mg perampanel PO QD for one week and 4mg perampanel PO QD for five weeks. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Neuropsychological Composite Z-score as a Measure of Direct Comparison of the 4 Titration Conditions Across 6 Weeks of Treatment. | Z score of cognitive tests (selected performance measures from the computerized cognitive test battery) and questionnaires (AEP, POMS, QOLIE-cognitive questions) at the end of each week of drug treatment for each titration arm, controlling for baseline measures collected prior to treatment. Various measures were combined collectively (averaged) to compute an overall Z-score for each group at each time point. These included: 1) Executive Function Score of computerized test battery; 2) Processing Speed Score of computerized test battery; 3) AEP total score; 4) POMS total and domain scores; 5) Three cognitive components of the QOLIE-31 (attention, memory, language). The Z-score indicates the number of standard deviations away from a reference population. A Z-score of 0 is equal to the mean. Negative numbers indicate poorer performance compared to the mean and positive numbers represent higher performance compared to the mean. | Participants who completed the protocol are included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | At the end of each week of treatment for 6 weeks. |
Up to 8 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants take 2mg placebo PO QD for six weeks. | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cyst in Nose | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
Enrollment was delayed due to the COVID-19 pandemic. The sponsor then decided to no longer fund the study. These caused total enrollment to be low, preventing statistical analyses from being conducted.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kimford Meador | Stanford University | 650-721-5552 | kmeador@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 2, 2022 | Apr 9, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C551441 | perampanel |
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| Perampanel 2 week titration | Drug | Healthy adults will take 2mg perampanel PO QD for two weeks followed 4mg perampanel PO QD for four weeks. |
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| Perampanel 4mg | Drug | Healthy adults will take 4mg perampanel PO QD for six weeks |
|
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| Placebo | Drug | Healthy adults will take 2mg placebo PO QD for six weeks |
|
| At the end of each week of treatment for 6 weeks. |
| Dropouts Across the Six-week Treatment Period Measure of Direct Comparison of the 4 Titration Conditions Across 6 Weeks of Treatment. | Number dropouts across the the four titration conditions over the six-week treatment period. A score of 0 indicates no dropouts. Higher numbers indicate greater dropouts. | At the end of each week of treatment for 6 weeks. |
| Chicago |
| Illinois |
| 60611 |
| United States |
| New York University | New York | New York | 10016 | United States |
| BG002 | PER 2 Week Titration | Participants take 2mg perampanel PO QD for two weeks and 4mg perampanel PO QD for four weeks. |
| BG003 | PER 4 mg | Participants take 4mg perampanel PO QD for six weeks |
| BG004 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Education Level | Education level was assessed by asking participants their highest level of education. Participants' responses was then converted to the number of years this level of education corresponds to. | Mean | Standard Deviation | Years |
|
| IQ Estimate | IQ estimate is the Peabody Picture Vocabulary Test, 4th ed. (PPVT-4). The overall standard score is reported. Ranges are 40 to 160. Higher scores indicate better performance. | Mean | Standard Deviation | units on a scale |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Placebo | Participants take 2mg placebo PO QD for six weeks. |
| OG001 | PER 1 Week Titration | Participants take 2mg perampanel PO QD for one week and 4mg perampanel PO QD for five weeks. |
| OG002 | PER 2 Week Titration | Participants take 2mg perampanel PO QD for two weeks and 4mg perampanel PO QD for four weeks. |
| OG003 | PER 4 mg | Participants take 4mg perampanel PO QD for six weeks |
|
|
| Primary | Composite Z-score of Objective Measures as a Measure of Direct Comparison of the 4 Titration Conditions Across 6 Weeks of Treatment. | Z score of objective cognitive tests (selected performance measures from the computerized cognitive test battery) at the end of each week of drug treatment for each titration arm, controlling for baseline measures collected prior to treatment. The Z-score indicates the number of standard deviations away from a reference population. A Z-score of 0 is equal to the mean. Negative numbers indicate poorer performance compared to the mean and positive numbers represent higher performance compared to the mean. | Participants who completed the protocol are included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | At the end of each week of treatment for 6 weeks. |
|
|
|
| Primary | Composite Z-score of Subjective Measures as a Measure of Direct Comparison of the 4 Titration Conditions Across 6 Weeks of Treatment. | Z score of subjective questionnaires (AEP, POMS, QOLIE-cognitive questions at the end of each week of drug treatment for each titration arm, controlling for baseline measures collected prior to treatment. Various measures were combined collectively (averaged) to compute an overall Z-score for each group at each time point. These included: 1) AEP total score; 2) POMS total and domain scores; 3) Three cognitive components of the QOLIE-31 (attention, memory, language). The Z-score indicates the number of standard deviations away from a reference population. A Z-score of 0 is equal to the mean. Negative numbers indicate poorer performance compared to the mean and positive numbers represent higher performance compared to the mean. | Participants who completed the protocol are included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | At the end of each week of treatment for 6 weeks. |
|
|
|
| Secondary | Treatment Emergent Adverse Events (TEAEs) Across the Six-week Treatment Period Measure of Direct Comparison of the 4 Titration Conditions Across 6 Weeks of Treatment. | Number of TEAEs across the the four titration conditions over the six-week treatment period. A score of 0 indicates no TEAEs. Higher numbers indicate greater TEAEs. | All participants who completed the protocol are included in the analysis. However, zero participants withdrew from the study after starting the study drug. | Posted | Number | TEAEs | At the end of each week of treatment for 6 weeks. |
|
|
|
| Secondary | Dropouts Across the Six-week Treatment Period Measure of Direct Comparison of the 4 Titration Conditions Across 6 Weeks of Treatment. | Number dropouts across the the four titration conditions over the six-week treatment period. A score of 0 indicates no dropouts. Higher numbers indicate greater dropouts. | All participants included in analysis. However, zero participants withdrew from the study after starting the study drug. | Posted | Count of Participants | Participants | At the end of each week of treatment for 6 weeks. |
|
|
|
| 2 |
| 0 |
| 2 |
| 1 |
| 2 |
| EG001 | PER 1 Week Titration | Participants take 2mg perampanel PO QD for one week and 4mg perampanel PO QD for five weeks. | 0 | 3 | 0 | 3 | 2 | 3 |
| EG002 | PER 2 Week Titration | Participants take 2mg perampanel PO QD for two weeks and 4mg perampanel PO QD for four weeks. | 0 | 6 | 0 | 6 | 5 | 6 |
| EG003 | PER 4 mg | Participants take 4mg perampanel PO QD for six weeks | 0 | 8 | 0 | 8 | 7 | 8 |
| Difficulty with concentration and word finding | Nervous system disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Fatigue | Nervous system disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Fall | General disorders | Systematic Assessment |
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| Problems with coordination | Nervous system disorders | Systematic Assessment |
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| Balance Problems/Unsteadiness | Nervous system disorders | Systematic Assessment |
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| Irritability | Nervous system disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Lip Cramping/Twitching | Nervous system disorders | Systematic Assessment |
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| Sore Throat | General disorders | Systematic Assessment |
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| Fever | General disorders | Systematic Assessment |
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| Hair Thinning | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Leg Abrasion | General disorders | Systematic Assessment |
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| Sleep Disturbance | Nervous system disorders | Systematic Assessment |
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| Hypertension | General disorders | Systematic Assessment |
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| Loss of muscle definition/fat distribution | General disorders | Systematic Assessment |
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| Low White Blood Cell Count | Blood and lymphatic system disorders | Systematic Assessment |
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| Low glucose level | General disorders | Systematic Assessment |
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| Cognitive Change: Slowing | Nervous system disorders | Systematic Assessment |
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| Weight Gain | General disorders | Systematic Assessment |
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| COVID-19 Infection | Infections and infestations | Systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | Systematic Assessment |
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