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This is a randomized, double-blind, two treatment, two group, parallel group study. Subjects will be randomized to one of two treatment groups (E2007 or Placebo) in a 3 to 1 ratio and receive treatment for a total of ten weeks (Days 1 to 70).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E2007 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Any TEAE | Treatment-emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that started on or after the first dose of study medication until the end of the study. Information on any AEs were recorded throughout the study after informed consent had been signed and included abnormal clinical laboratory tests, vital sign measurements and physical examinations. Note: Safety/tolerability info captured in Adverse Event section. | Through end of study |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Day 70 in "on" State of UPDRS Scores | The Unified Parkinson's Disease Rating Scale (UPDRS) consisted of 4 subsections used to assess symptoms and signs of Parkinson's disease, with an overall scale range of 0-147. Individual subsections included: I. Mentation, behavior, and mood (0-16); II. Activities of daily living assessed in both the "on" and "off" state (0-52); III. Motor examination (0-56); and IV. Complications of therapy assessed in the "on" fluctuations and dyskinesias (0-23). Each subsection included subscales that ranged from 0 (best possible outcome) to 1 or 4 (worst possible outcome), with the total score of subsection equaling the sum of the scores of the subscales and the overall UPDRS score equaling the sum of the scores of the 4 subsections (higher score indicating more severe Parkinson's Disease). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Santiago Arroyo, M.D., Ph.D | Eisai Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trials Incorporated | Little Rock | Arkansas | 72205 | United States | ||
| UMDNJ - Robert Wood Johnson Medical School |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 - Placebo | Placebo matching Perampanel dosing once daily for 10 weeks. |
| FG001 | Cohort 1 - Perampanel | Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Baseline and Day 70 |
| Change From Baseline to Day 70 in Absolute "Off" Time | Subjects and/or caregiver completed a diary recording their motor state and dyskinesia symptoms over the course of the day before and at the end of study drug dosing on 3 consecutive days leading up to Baseline and Day 70. An entry was made every 30 minutes whether they were in the "on" state experiencing troubling dyskinesias or "off" state. The "on" state reflected recovery of control of a particular Parkinsonian feature that readily responded to each dose of levodopa, while the "off" state reflected the re-emergence of that feature. Troublesome dyskinesias were unintentional movements that occurred while in the "on" state and which interfered with activities or caused discomfort to any extent. | Baseline and Day 70 |
| Change From Baseline to Day 70 in Absolute "on" Time With Non-troublesome Dyskinesias | Subjects and/or caregiver completed a diary recording their motor state and dyskinesia symptoms over the course of the day before and at the end of study drug dosing on 3 consecutive days leading up to Baseline and Day 70. An entry was made every 30 minutes whether they were in the "on" state experiencing troubling dyskinesias or "off" state. The "on" state reflected recovery of control of a particular Parkinsonian feature that readily responded to each dose of levodopa, while the "off" state reflected the re-emergence of that feature. Troublesome dyskinesias were unintentional movements that occurred while in the "on" state and which interfered with activities or caused discomfort to any extent. | Baseline and Day 70 |
| Change From Baseline to Day 70 in Absolute "on" Time With Troublesome Dyskinesias | Subjects and/or caregiver completed a diary recording their motor state and dyskinesia symptoms over the course of the day before and at the end of study drug dosing on 3 consecutive days leading up to Baseline and Day 70. An entry was made every 30 minutes whether they were in the "on" state experiencing troubling dyskinesias or "off" state. The "on" state reflected recovery of control of a particular Parkinsonian feature that readily responded to each dose of levodopa, while the "off" state reflected the re-emergence of that feature. Troublesome dyskinesias were unintentional movements that occurred while in the "on" state and which interfered with activities or caused discomfort to any extent. | Baseline and Day 70 |
| Change From Baseline to Day 70 in Goetz/Rush Score | The Goetz/Rush scale was used to rate severity during performance of tasks intended to elicit dyskinesias, and provided an objective rating of dyskinesias during activities of daily living.The tasks included a sitting exercise, mental calculations, drinking, dressing, and walking. A 5-point scale was used: 0=absent; 1=minimal severity, no interference with voluntary motor acts; 2=dyskinesias, may impair voluntary movements but the subject was capable of efficiently completing the motor task; 3=intense dyskinesias, interference with movement control and completion of the motor task was greatly limited; 4= violent dyskinesias, incompatible with the completion of the motor task. A lower score indicated less difficulty performing the tasks. | Baseline and Day 70 |
| Change From Baseline to Day 70 in Percent "Off" Time | Subjects and/or caregiver completed a diary recording their motor state and dyskinesia symptoms over the course of the day before and at the end of study drug dosing on 3 consecutive days leading up to Baseline and Day 70. An entry was made every 30 minutes whether they were in the "on" state experiencing troubling dyskinesias or "off" state. The "on" state reflected recovery of control of a particular Parkinsonian feature that readily responded to each dose of levodopa, while the "off" state reflected the re-emergence of that feature. Troublesome dyskinesias were unintentional movements that occurred while in the "on" state and which interfered with activities or caused discomfort to any extent. | Baseline and Day 70 |
| Change From Baseline to Day 70 in Percent "on" Time | Subjects and/or caregiver completed a diary recording their motor state and dyskinesia symptoms over the course of the day before and at the end of study drug dosing on 3 consecutive days leading up to Baseline and Day 70. An entry was made every 30 minutes whether they were in the "on" state experiencing troubling dyskinesias or "off" state. The "on" state reflected recovery of control of a particular Parkinsonian feature that readily responded to each dose of levodopa, while the "off" state reflected the re-emergence of that feature. Troublesome dyskinesias were unintentional movements that occurred while in the "on" state and which interfered with activities or caused discomfort to any extent. | Baseline and Day 70 |
| Change From Baseline to Day 70 in Percent "on" Time With Non-troublesome Dyskinesias | Subjects and/or caregiver completed a diary recording their motor state and dyskinesia symptoms over the course of the day before and at the end of study drug dosing on 3 consecutive days leading up to Baseline and Day 70. An entry was made every 30 minutes whether they were in the "on" state experiencing troubling dyskinesias or "off" state. The "on" state reflected recovery of control of a particular Parkinsonian feature that readily responded to each dose of levodopa, while the "off" state reflected the re-emergence of that feature. Troublesome dyskinesias were unintentional movements that occurred while in the "on" state and which interfered with activities or caused discomfort to any extent. | Baseline and Day 70 |
| Disability of Dyskinesia From UPDRS at Baseline and Day 70 | The disability of dyskinesia was determined from question 33 (part 4) of the UPDRS assessment. It asks how disabling are the dyskinesias, and uses a 5-part scale: 0=Not disabling, 1=MIldly disabling, 2=Moderately disabling, 3=Severely disabling, 4=Completely disabling. Lower scores represented more normal functioning. | Baseline and Day 70 |
| Duration of Dyskinesia From UPDRS at Baseline and Day 70 | The duration of dyskinesia was determined from question 32 (part 4) of the UPDRS assessment. It asks what proportion of the waking day are dyskinesias present, and uses a 5-part scale: 0 = None, 1 = 1-25% of day, 2 = 26-50% of day, 3 = 51-75% of day, 4 = 76-100% of day. Lower scores represented more normal functioning. | Baseline and Day 70 |
| Oxnard |
| California |
| 93030 |
| United States |
| Parkinson's Disease and Movement Disorders Center of Boca Raton | New Haven | Connecticut | 06510 | United States |
| Inc. | Boca Raton | Florida | 33486 | United States |
| Brain Matters Research | Delray Beach | Florida | 33445 | United States |
| Suncoast Neuroscience Associates | St. Petersburg | Florida | 33701 | United States |
| Raleigh Neurology Associates | Southfield | Michigan | 48034 | United States |
| Agape Medical Research Center | Piscataway | New Jersey | 08854 | United States |
| Inc. | Raleigh | North Carolina | 27607 | United States |
| The Clinical Neuroscience Center | Lubbock | Texas | 79410 | United States |
| FG002 | Cohort 2- Placebo | Placebo matching Perampanel dosing once daily for 10 weeks. |
| FG003 | Cohort 2 - Perampanel | Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 - Placebo | Placebo matching Perampanel dosing once daily for 10 weeks. |
| BG001 | Cohort 1 - Perampanel | Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks. |
| BG002 | Cohort 2 - Placebo | Placebo matching Perampanel dosing once daily for 10 weeks. |
| BG003 | Cohort 2 - Perampanel | Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Change From Baseline to Day 70 in "on" State of UPDRS Scores | The Unified Parkinson's Disease Rating Scale (UPDRS) consisted of 4 subsections used to assess symptoms and signs of Parkinson's disease, with an overall scale range of 0-147. Individual subsections included: I. Mentation, behavior, and mood (0-16); II. Activities of daily living assessed in both the "on" and "off" state (0-52); III. Motor examination (0-56); and IV. Complications of therapy assessed in the "on" fluctuations and dyskinesias (0-23). Each subsection included subscales that ranged from 0 (best possible outcome) to 1 or 4 (worst possible outcome), with the total score of subsection equaling the sum of the scores of the subscales and the overall UPDRS score equaling the sum of the scores of the 4 subsections (higher score indicating more severe Parkinson's Disease). | Safety Population. Change from Baseline only reflect participants who completed the assessment at Baseline and Day 70. | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline and Day 70 |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Day 70 in Absolute "Off" Time | Subjects and/or caregiver completed a diary recording their motor state and dyskinesia symptoms over the course of the day before and at the end of study drug dosing on 3 consecutive days leading up to Baseline and Day 70. An entry was made every 30 minutes whether they were in the "on" state experiencing troubling dyskinesias or "off" state. The "on" state reflected recovery of control of a particular Parkinsonian feature that readily responded to each dose of levodopa, while the "off" state reflected the re-emergence of that feature. Troublesome dyskinesias were unintentional movements that occurred while in the "on" state and which interfered with activities or caused discomfort to any extent. | Safety Population. Change from Baseline only reflect participants who completed the assessment at Baseline and Day 70. | Posted | Mean | Standard Deviation | Hour | Baseline and Day 70 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Day 70 in Absolute "on" Time With Non-troublesome Dyskinesias | Subjects and/or caregiver completed a diary recording their motor state and dyskinesia symptoms over the course of the day before and at the end of study drug dosing on 3 consecutive days leading up to Baseline and Day 70. An entry was made every 30 minutes whether they were in the "on" state experiencing troubling dyskinesias or "off" state. The "on" state reflected recovery of control of a particular Parkinsonian feature that readily responded to each dose of levodopa, while the "off" state reflected the re-emergence of that feature. Troublesome dyskinesias were unintentional movements that occurred while in the "on" state and which interfered with activities or caused discomfort to any extent. | Safety Population. Change from Baseline only reflect participants who completed the assessment at Baseline and Day 70. | Posted | Mean | Standard Deviation | Hours | Baseline and Day 70 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Day 70 in Absolute "on" Time With Troublesome Dyskinesias | Subjects and/or caregiver completed a diary recording their motor state and dyskinesia symptoms over the course of the day before and at the end of study drug dosing on 3 consecutive days leading up to Baseline and Day 70. An entry was made every 30 minutes whether they were in the "on" state experiencing troubling dyskinesias or "off" state. The "on" state reflected recovery of control of a particular Parkinsonian feature that readily responded to each dose of levodopa, while the "off" state reflected the re-emergence of that feature. Troublesome dyskinesias were unintentional movements that occurred while in the "on" state and which interfered with activities or caused discomfort to any extent. | Safety Population. Change from Baseline only reflect participants who completed the assessment at Baseline and Day 70. | Posted | Mean | Standard Deviation | Hours | Baseline and Day 70 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Day 70 in Goetz/Rush Score | The Goetz/Rush scale was used to rate severity during performance of tasks intended to elicit dyskinesias, and provided an objective rating of dyskinesias during activities of daily living.The tasks included a sitting exercise, mental calculations, drinking, dressing, and walking. A 5-point scale was used: 0=absent; 1=minimal severity, no interference with voluntary motor acts; 2=dyskinesias, may impair voluntary movements but the subject was capable of efficiently completing the motor task; 3=intense dyskinesias, interference with movement control and completion of the motor task was greatly limited; 4= violent dyskinesias, incompatible with the completion of the motor task. A lower score indicated less difficulty performing the tasks. | Safety Population. Change from Baseline only reflect participants who completed the assessment at Baseline and Day 70. | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline and Day 70 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Day 70 in Percent "Off" Time | Subjects and/or caregiver completed a diary recording their motor state and dyskinesia symptoms over the course of the day before and at the end of study drug dosing on 3 consecutive days leading up to Baseline and Day 70. An entry was made every 30 minutes whether they were in the "on" state experiencing troubling dyskinesias or "off" state. The "on" state reflected recovery of control of a particular Parkinsonian feature that readily responded to each dose of levodopa, while the "off" state reflected the re-emergence of that feature. Troublesome dyskinesias were unintentional movements that occurred while in the "on" state and which interfered with activities or caused discomfort to any extent. | Safety Population. Change from Baseline only reflect participants who completed the assessment at Baseline and Day 70. | Posted | Mean | Standard Deviation | Percentage of the Day | Baseline and Day 70 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Day 70 in Percent "on" Time | Subjects and/or caregiver completed a diary recording their motor state and dyskinesia symptoms over the course of the day before and at the end of study drug dosing on 3 consecutive days leading up to Baseline and Day 70. An entry was made every 30 minutes whether they were in the "on" state experiencing troubling dyskinesias or "off" state. The "on" state reflected recovery of control of a particular Parkinsonian feature that readily responded to each dose of levodopa, while the "off" state reflected the re-emergence of that feature. Troublesome dyskinesias were unintentional movements that occurred while in the "on" state and which interfered with activities or caused discomfort to any extent. | Safety Population. Change from Baseline only reflect participants who completed the assessment at Baseline and Day 70. | Posted | Mean | Standard Deviation | Percentage of the Day | Baseline and Day 70 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Day 70 in Percent "on" Time With Non-troublesome Dyskinesias | Subjects and/or caregiver completed a diary recording their motor state and dyskinesia symptoms over the course of the day before and at the end of study drug dosing on 3 consecutive days leading up to Baseline and Day 70. An entry was made every 30 minutes whether they were in the "on" state experiencing troubling dyskinesias or "off" state. The "on" state reflected recovery of control of a particular Parkinsonian feature that readily responded to each dose of levodopa, while the "off" state reflected the re-emergence of that feature. Troublesome dyskinesias were unintentional movements that occurred while in the "on" state and which interfered with activities or caused discomfort to any extent. | Safety Population. Change from Baseline only reflect participants who completed the assessment at Baseline and Day 70. | Posted | Mean | Standard Deviation | Percentage of the Day | Baseline and Day 70 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Disability of Dyskinesia From UPDRS at Baseline and Day 70 | The disability of dyskinesia was determined from question 33 (part 4) of the UPDRS assessment. It asks how disabling are the dyskinesias, and uses a 5-part scale: 0=Not disabling, 1=MIldly disabling, 2=Moderately disabling, 3=Severely disabling, 4=Completely disabling. Lower scores represented more normal functioning. | Safety Population | Posted | Number | Participants | Baseline and Day 70 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Dyskinesia From UPDRS at Baseline and Day 70 | The duration of dyskinesia was determined from question 32 (part 4) of the UPDRS assessment. It asks what proportion of the waking day are dyskinesias present, and uses a 5-part scale: 0 = None, 1 = 1-25% of day, 2 = 26-50% of day, 3 = 51-75% of day, 4 = 76-100% of day. Lower scores represented more normal functioning. | Safety Population | Posted | Number | Participants | Baseline and Day 70 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Any TEAE | Treatment-emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that started on or after the first dose of study medication until the end of the study. Information on any AEs were recorded throughout the study after informed consent had been signed and included abnormal clinical laboratory tests, vital sign measurements and physical examinations. Note: Safety/tolerability info captured in Adverse Event section. | Safety Population was the primary population for analysis defined as all subjects who completed the Baseline Phase and who received at least 1 dose of double-blind study medication. | Posted | Number | Participants | Through end of study |
|
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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 | Cohort 1 - Placebo | Placebo matching Perampanel dosing once daily for 10 weeks. | 0 | 8 | 7 | 8 | ||
| EG001 | Cohort 1 - Perampanel | Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks. | 4 | 20 | 18 | 20 | ||
| EG002 | Cohort 2 - Placebo | Placebo matching Perampanel dosing once daily for 10 weeks. | 0 | 12 | 8 | 12 | ||
| EG003 | Cohort 2 - Perampanel | Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks. | 4 | 35 | 32 | 35 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| FALL | Injury, poisoning and procedural complications | MedDRA Version 8.1 | Systematic Assessment |
| |
| HIP FRACTURE | Injury, poisoning and procedural complications | MedDRA Version 8.1 | Systematic Assessment |
| |
| LUMBAR VERTEBRAL FRACTURE | Injury, poisoning and procedural complications | MedDRA Version 8.1 | Systematic Assessment |
| |
| PELVIC FRACTURE | Injury, poisoning and procedural complications | MedDRA Version 8.1 | Systematic Assessment |
| |
| TIBIA FRACTURE | Injury, poisoning and procedural complications | MedDRA Version 8.1 | Systematic Assessment |
| |
| ELECTROCARDIOGRAM ABNORMAL | Investigations | MedDRA Version 8.1 | Systematic Assessment |
| |
| HEMIPARESIS | Nervous system disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| PARKINSON'S DISEASE | Nervous system disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| CONFUSIONAL STATE | Psychiatric disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| MENTAL STATUS CHANGES | Psychiatric disorders | MedDRA Version 8.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| ATRIAL FLUTTER | Cardiac disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| ATRIOVENTRICULAR BLOCK FIRST DEGREE | Cardiac disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| PALPITATIONS | Cardiac disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| SUPRAVENTRICULAR EXTRASYSTOLES | Cardiac disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| TACHYCARDIA | Cardiac disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| EAR DISCOMFORT | Ear and labyrinth disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| EAR PAIN | Ear and labyrinth disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| VERTIGO | Ear and labyrinth disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| LACRIMATION INCREASED | Eye disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| DYSPHAGIA | Gastrointestinal disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| GASTRITIS ATROPHIC | Gastrointestinal disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| HIATUS HERNIA | Gastrointestinal disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| DIFFICULTY IN WALKING | General disorders | MedDRA Version 8.1 | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| GAIT DISTURBANCE | General disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| DENTAL CARIES | Infections and infestations | MedDRA Version 8.1 | Systematic Assessment |
| |
| HELICOBACTER INFECTION | Infections and infestations | MedDRA Version 8.1 | Systematic Assessment |
| |
| LARYNGITIS | Infections and infestations | MedDRA Version 8.1 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA Version 8.1 | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA Version 8.1 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA Version 8.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA Version 8.1 | Systematic Assessment |
| |
| CONTUSION | Injury, poisoning and procedural complications | MedDRA Version 8.1 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA Version 8.1 | Systematic Assessment |
| |
| HIP FRACTURE | Injury, poisoning and procedural complications | MedDRA Version 8.1 | Systematic Assessment |
| |
| LUMBAR VERTEBRAL FRACTURE | Injury, poisoning and procedural complications | MedDRA Version 8.1 | Systematic Assessment |
| |
| PELVIC FRACTURE | Injury, poisoning and procedural complications | MedDRA Version 8.1 | Systematic Assessment |
| |
| PROCEDURAL PAIN | Injury, poisoning and procedural complications | MedDRA Version 8.1 | Systematic Assessment |
| |
| TIBIA FRACTURE | Injury, poisoning and procedural complications | MedDRA Version 8.1 | Systematic Assessment |
| |
| BLOOD CHOLESTEROL INCREASED | Investigations | MedDRA Version 8.1 | Systematic Assessment |
| |
| BLOOD CREATINE PHOSPHOKINASE INCREASED | Investigations | MedDRA Version 8.1 | Systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | MedDRA Version 8.1 | Systematic Assessment |
| |
| BLOOD PRESSURE DECREASED | Investigations | MedDRA Version 8.1 | Systematic Assessment |
| |
| BLOOD PRESSURE INCREASED | Investigations | MedDRA Version 8.1 | Systematic Assessment |
| |
| ELECTROCARDIOGRAM CHANGE | Investigations | MedDRA Version 8.1 | Systematic Assessment |
| |
| ELECTROCARDIOGRAM ST SEGMENT DEPRESSION | Investigations | MedDRA Version 8.1 | Systematic Assessment |
| |
| HEART RATE INCREASED | Investigations | MedDRA Version 8.1 | Systematic Assessment |
| |
| URINARY CASTS | Investigations | MedDRA Version 8.1 | Systematic Assessment |
| |
| URINE LEUKOCYTE | Investigations | MedDRA Version 8.1 | Systematic Assessment |
| |
| WHITE BLOOD CELLS URINE POSITIVE | Investigations | MedDRA Version 8.1 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| MUSCLE RIGIDITY | Musculoskeletal and connective tissue disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| MUSCULOSKELETAL STIFFNESS | Musculoskeletal and connective tissue disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| POSTURE ABNORMAL | Musculoskeletal and connective tissue disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| SHOULDER PAIN | Musculoskeletal and connective tissue disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| TENDONITIS | Musculoskeletal and connective tissue disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| BALANCE DISORDER | Nervous system disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| BRADYKINESIA | Nervous system disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| CHOREA | Nervous system disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| DISTURBANCE IN ATTENTION | Nervous system disorders | MedDRA Version 8.1 | Systematic Assessment |
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| DIZZINESS | Nervous system disorders | MedDRA Version 8.1 | Systematic Assessment |
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| DIZZINESS POSTURAL | Nervous system disorders | MedDRA Version 8.1 | Systematic Assessment |
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| DROOLING | Nervous system disorders | MedDRA Version 8.1 | Systematic Assessment |
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| DYSGEUSIA | Nervous system disorders | MedDRA Version 8.1 | Systematic Assessment |
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| DYSKINESIA | Nervous system disorders | MedDRA Version 8.1 | Systematic Assessment |
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| DYSTONIA | Nervous system disorders | MedDRA Version 8.1 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA Version 8.1 | Systematic Assessment |
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| HYPERREFLEXIA | Nervous system disorders | MedDRA Version 8.1 | Systematic Assessment |
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| MUSCLE SPASTICITY | Nervous system disorders | MedDRA Version 8.1 | Systematic Assessment |
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| NYSTAGMUS | Nervous system disorders | MedDRA Version 8.1 | Systematic Assessment |
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| PARKINSON'S DISEASE | Nervous system disorders | MedDRA Version 8.1 | Systematic Assessment |
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| SEDATION | Nervous system disorders | MedDRA Version 8.1 | Systematic Assessment |
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| SOMNOLENCE | Nervous system disorders | MedDRA Version 8.1 | Systematic Assessment |
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| TREMOR | Nervous system disorders | MedDRA Version 8.1 | Systematic Assessment |
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| TUNNEL VISION | Nervous system disorders | MedDRA Version 8.1 | Systematic Assessment |
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| ABNORMAL DREAMS | Psychiatric disorders | MedDRA Version 8.1 | Systematic Assessment |
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| CONFUSIONAL STATE | Psychiatric disorders | MedDRA Version 8.1 | Systematic Assessment |
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| DELUSION | Psychiatric disorders | MedDRA Version 8.1 | Systematic Assessment |
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| DEPRESSION | Psychiatric disorders | MedDRA Version 8.1 | Systematic Assessment |
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| HALLUCINATION,VISUAL | Psychiatric disorders | MedDRA Version 8.1 | Systematic Assessment |
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| IMPULSIVE BEHAVIOUR | Psychiatric disorders | MedDRA Version 8.1 | Systematic Assessment |
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| INITIAL INSOMNIA | Psychiatric disorders | MedDRA Version 8.1 | Systematic Assessment |
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| INSOMNIA | Psychiatric disorders | MedDRA Version 8.1 | Systematic Assessment |
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| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA Version 8.1 | Systematic Assessment |
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| DERMATITIS CONTACT | Skin and subcutaneous tissue disorders | MedDRA Version 8.1 | Systematic Assessment |
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| ECCHYMOSIS | Skin and subcutaneous tissue disorders | MedDRA Version 8.1 | Systematic Assessment |
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| RASH | Skin and subcutaneous tissue disorders | MedDRA Version 8.1 | Systematic Assessment |
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| SKIN LESION | Skin and subcutaneous tissue disorders | MedDRA Version 8.1 | Systematic Assessment |
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| SWELLING FACE | Skin and subcutaneous tissue disorders | MedDRA Version 8.1 | Systematic Assessment |
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| HYPERTENSION | Vascular disorders | MedDRA Version 8.1 | Systematic Assessment |
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| HYPOTENSION | Vascular disorders | MedDRA Version 8.1 | Systematic Assessment |
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| ORTHOSTATIC HYPOTENSION | Vascular disorders | MedDRA Version 8.1 | Systematic Assessment |
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Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eisai Inc. | Eisai Call Center | 888-422-4743 |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C551441 | perampanel |
Not provided
Not provided
Not provided
| Male |
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| Mentation, Behavior, and Mood |
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| Activities of Daily Living |
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| Motor Examinations |
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| Complications of Therapy |
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Placebo matching Perampanel dosing once daily for 10 weeks. |
| OG003 | Cohort 2 - Perampanel | Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks. |
|
|
Placebo matching Perampanel dosing once daily for 10 weeks. |
| OG003 | Cohort 2 - Perampanel | Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks. |
|
|
Placebo matching Perampanel dosing once daily for 10 weeks. |
| OG003 | Cohort 2 - Perampanel | Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks. |
|
|
| Cohort 2 - Placebo |
Placebo matching Perampanel dosing once daily for 10 weeks. |
| OG003 | Cohort 2 - Perampanel | Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks. |
|
|
Placebo matching Perampanel dosing once daily for 10 weeks. |
| OG003 | Cohort 2 - Perampanel | Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks. |
|
|
Placebo matching Perampanel dosing once daily for 10 weeks. |
| OG003 | Cohort 2 - Perampanel | Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks. |
|
|
| Cohort 2 - Placebo |
Placebo matching Perampanel dosing once daily for 10 weeks. |
| OG003 | Cohort 2 - Perampanel | Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks. |
|
|
|
|
|
|
| OG003 |
| Cohort 2 - Perampanel |
Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks. |
|
|