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The purpose of the study is to determine the efficacy and safety of Perampanel (E2007) in patients with Post-Herpetic Neuralgia (PHN).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Cohort 1 | Placebo Comparator |
| |
| Perampanel Cohort 1, 3-week Titration | Experimental |
| |
| Placebo Cohort 2 | Experimental |
| |
| Perampanel Cohort 2, 1-week Titration | Experimental |
| |
| Perampanel Cohort 2, 2- Week Titration | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E2007 (perampanel) | Drug | 2 mg titrated up to 8 mg maximum; taken once daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Average Pain Scores to Week 15/ End of Treatment (EOT) (Including Modified BOCF Data) | Average pain scores are based on pain intensity (11-point Likert-type numerical scale, where 0=no pain and 10=worst possible pain), reported by the subjects in a daily diary. The average pain score for baseline was calculated using the average of the last 7 scores prior to randomization, and the average pain score for Week 15 was computed using the average of the last 7 on-treatment scores prior to Week 15, and they were reported by treatment group. | Baseline and Week 15 |
| Responder Rate: Subjects With at Least 30 Percent Reduction in Pain | A responder was a participant with at least 30 percent reduction in average pain scores, using modified BOCF, based on pain intensity (11-point Likert-type numerical scale where 0=no pain and 10=worst possible pain), reported by the subjects in a daily diary. The average pain score for baseline was calculated using the average of the last 7 scores prior to randomization, and the average pain score for Week 15 was computed using the average of the last 7 on-treatment scores prior to Week 15, and they were reported by treatment group. | Baseline and Week 15 |
| Responder Rate: Subjects With at Least 50 Percent Reduction in Pain | A responder was a participant with at least 50 percent reduction in average pain scores, using modified BOCF, based on pain intensity (11-point Likert-type numerical scale where 0=no pain and 10=worst possible pain), reported by the subjects in a daily diary. The average pain score for baseline was calculated using the average of the last 7 scores prior to randomization, and the average pain score for Week 15 was computed using the average of the last 7 on-treatment scores prior to Week 15, and they were reported by treatment group. | Baseline and Week 15 |
| Change From Baseline in Average Pain Scores by Week | Change from baseline in average pain scores by week based on pain intensity (11-point Likert-type numerical scale where 0=no pain and 10=worst possible pain), reported by the subjects in a daily diary. The average pain scores were calculated as the average of available scores in each week, and were reported by treatment group. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 15/EOT in Average Sleep Interference Scores | The average of the last 7 available sleep scores prior to the visit, based on the 11-point Likert-type numerical rating scale for sleep interference (where 0=pain did not interfere with sleep, to 10=pain completely interfered with sleep [unable to sleep]), and they were reported by treatment group. | Baseline and Week 15 |
Not provided
Inclusion Criteria:
To be included, patients must meet the following:
Provide written informed consent, prior to entering the study or undergoing any study procedures.
Male and female patients ≥18 years of age. Females should be either of nonchildbearing potential as a result of surgery or menopause (1 year after onset), or of childbearing potential and practicing a medically acceptable method of contraception. Acceptable contraception includes: abstinence, a barrier method plus spermicide, or intrauterine device [IUD]. Those females using hormonal contraceptives must also be using an additional approved method of contraception (e.g., a barrier method plus spermicide or IUD). Contraceptive use must start at least 1 month before Visit 1, be practiced throughout the entire study period, and continue for 1 month after the end of the study. They must also have a negative serum beta-human chorionic gonadotropin (β-hCG) at Visit 1, and a negative urine pregnancy test at Baseline Visit 2.
PHN of at least 6 months duration; the onset of PHN is defined as the time from healing of herpes zoster skin lesions.
Pain over the past 6 months, and not in a clinically identifiable improving or worsening trend, based on medical history.
Score of ≥ 40 mm on the visual analog scale (VAS) of the short form McGill Pain Questionnaire (SF-MPQ) at both Visit 1 and Baseline (Visit 2 prior to randomization).
Have completed the patient diary for at least 6 of the 7 days prior to Visit 2 (Baseline).
Average daily pain score of ≥ 4, on 11-point Likert scale during the 7 days prior to randomization [from the diaries].
Reliable and willing and able to cooperate with all study procedures, including the following examples:
Be on stable analgesic treatment (same medication(s)) or stable nonpharmacological pain treatment for at least 4 weeks prior to Visit 1 and remain on this stable treatment throughout the study. Nonpharmacologic pain treatment includes the following:
Exclusion Criteria:
Patients with any of the following are to be excluded:
Any condition that could interfere with the conduct of the trial or confound efficacy evaluations including the following examples: pain or neuropathy from another cause (including painful diabetic neuropathy), such as central pain, radiculopathy, painful arthritis, etc.
Motivation by secondary gain, or where there is a negative-incentive to achieving pain and functional relief (eg, litigation). This will be determined from the medical history and is at the discretion of the investigator.
Inability to cooperate with protocol, for any reason.
Clinically significant, progressive, or potentially unstable disease of any body system including cardiovascular, gastrointestinal, CNS, psychiatric, endocrine, or immunologic, including patients with any of the following broad disease categories:
Any of the following laboratory abnormalities at Visit 1:
Exposure to an investigational drug within the 30 days prior to Visit 1 or exposure ever to perampanel.
Females who are pregnant, lactating, or planning to become pregnant during the study.
Use of any medication known to be a strong inducer of CYP3A4 activity within 4 weeks prior to Visit 1; use of CYP3A4 inducers is prohibited for the entire study duration.
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| Name | Affiliation | Role |
|---|---|---|
| Allison Mann, MD | Eisai Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peoria | Arizona | United States | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Cohort 1 | Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter) |
| FG001 | Perampanel Cohort 1, 3-week Titration |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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|
| Placebo | Drug | 2 mg titrated up to 8 mg maximum; taken once daily. |
|
| Week 1 through Week 16 |
| Patient Global Impression of Change (PGIC) at Week 15/EOT | Changes were calculated using the modified BOCF method | Week 15 |
| Clinician Global Impression of Change (CGIC) at Week 15/EOT | Changes were calculated using the modified BOCF method | Week 15 |
| Change From Baseline to Week 15/EOT in HADS Anxiety Subscale Scores (Modified BOCF) | The HADS (Hospital Anxiety and Depression Scale) is a widely used, self-reported, 14-item instrument that measures the presence and severity of anxiety and depression. It consists of 2 subscales; a 7-item anxiety subscale (HADS-A) and a 7-item depression subscale (HADS-D). HADS-A consists of a 7-item scale, each scored on a 4-pt scale (0, 1, 2, or 3), where a higher score indicates worse anxiety. Range of possible HADS anxiety subscale scores is 0 to 21, and normal=(0-7), mild=(8-10), moderate=(11-14), and severe=(15-21). | Baseline and Week 15 |
| Change From Baseline to Week 15/EOT in HADS Depression Subscale Scores (Modified BOCF) | The HADS (Hospital Anxiety and Depression Scale) is a widely used, self-reported, 14-item instrument that measures the presence and severity of anxiety and depression. It consists of 2 subscales; a 7-item anxiety subscale (HADS-A) and a 7-item depression subscale (HADS-D). HADS-D consists of a 7-item scale, each scored on a 4-pt scale (0, 1, 2, or 3), where a higher score indicates worse depression. Range of possible HADS depression subscale scores is 0 to 21, and normal=(0-7), mild=(8-10), moderate=(11-14), and severe=(15-21). | Baseline and Week 15 |
| Analysis of Allodynia (Present/Not Present) at Week 15/EOT- by Treatment Groups ITT Population (Modified BOCF) | Allodynia is defined as a painful reaction to a non-painful stimulus. | Week 15 |
| Tucson |
| Arizona |
| United States |
| Little Rock | Arkansas | United States |
| Los Angeles | California | United States |
| Sacramento | California | United States |
| San Diego | California | United States |
| San Francisco | California | United States |
| Boulder | Colorado | United States |
| Denver | Colorado | United States |
| Milford | Connecticut | United States |
| Boca Raton | Florida | United States |
| Bradenton | Florida | United States |
| Daytona Beach | Florida | United States |
| Delray Beach | Florida | United States |
| Fort Lauderdale | Florida | United States |
| Fort Myers | Florida | United States |
| Kissimmee | Florida | United States |
| Largo | Florida | United States |
| Miami | Florida | United States |
| Naples | Florida | United States |
| Orlando | Florida | United States |
| Palm Beach Gardens | Florida | United States |
| Sarasota | Florida | United States |
| St. Petersburg | Florida | United States |
| Sunrise | Florida | United States |
| Tampa | Florida | United States |
| Pain and Rehabilitation Clinic of Chicago | Chicago | Illinois | 60610 | United States |
| Chicago | Illinois | United States |
| Towson | Maryland | United States |
| Boston | Massachusetts | United States |
| West Yarmouth | Massachusetts | United States |
| Southfield | Michigan | United States |
| Missoula | Montana | United States |
| Las Vegas | Nevada | United States |
| Brooklyn | New York | United States |
| High Point | North Carolina | United States |
| Winston-Salem | North Carolina | United States |
| Kettering | Ohio | United States |
| Bensalem | Pennsylvania | United States |
| Norristown | Pennsylvania | United States |
| Warwick | Rhode Island | United States |
| Dallas | Texas | United States |
| Kelowna | British Columbia | Canada |
| Sarnia | Ontario | Canada |
| Toronto | Ontario | Canada |
| Pointe-Claire | Quebec | Canada |
| Saskatoon | Saskatchewan | Canada |
Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up-titrated at 3-week intervals by 2mg steps to a total of 8mg or MTD [maximum tolerated dose] and continued at this dose until Week 15) |
| FG002 | Placebo Cohort 2 | Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter) |
| FG003 | Perampanel Cohort 2, 1-week Titration | Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up-titrated at 1-week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15) |
| FG004 | Perampanel Cohort 2, 2- Week Titration | Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up-titrated at 2-week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Cohort 1 | Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter) |
| BG001 | Perampanel Cohort 1, 3-week Titration | Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up-titrated at 3-week intervals by 2mg steps to a total of 8mg or MTD [maximum tolerated dose] and continued at this dose until Week 15) |
| BG002 | Placebo Cohort 2 | Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter) |
| BG003 | Perampanel Cohort 2, 1-week Titration | Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up-titrated at 1-week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15) |
| BG004 | Perampanel Cohort 2, 2- Week Titration | Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up-titrated at 2-week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15) |
| BG005 | 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, Customized | Safety population | Number | Participants |
| |||||||||||||||
| Sex: Female, Male | Safety population-subjects who were randomized, took at least 1 dose of study drug, and had at least 1 post-baseline assessment | Count of Participants | Participants |
| |||||||||||||||
| Race/Ethnicity, Customized | Race (Safety population) | Number | 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 | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Average Pain Scores to Week 15/ End of Treatment (EOT) (Including Modified BOCF Data) | Average pain scores are based on pain intensity (11-point Likert-type numerical scale, where 0=no pain and 10=worst possible pain), reported by the subjects in a daily diary. The average pain score for baseline was calculated using the average of the last 7 scores prior to randomization, and the average pain score for Week 15 was computed using the average of the last 7 on-treatment scores prior to Week 15, and they were reported by treatment group. | Intent-to-Treat (ITT) Population- group of subjects who were randomized, took study drug, and had at least 1 efficacy assessment at Baseline. The modified Baseline Observation Carried Forward (BOCF) method was used. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and Week 15 |
|
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Responder Rate: Subjects With at Least 30 Percent Reduction in Pain | A responder was a participant with at least 30 percent reduction in average pain scores, using modified BOCF, based on pain intensity (11-point Likert-type numerical scale where 0=no pain and 10=worst possible pain), reported by the subjects in a daily diary. The average pain score for baseline was calculated using the average of the last 7 scores prior to randomization, and the average pain score for Week 15 was computed using the average of the last 7 on-treatment scores prior to Week 15, and they were reported by treatment group. | ITT Population (Modified BOCF) | Posted | Number | Percentage of Participants | Baseline and Week 15 |
| ||||||||||||||||||||||||||||||||||||||||
| Primary | Responder Rate: Subjects With at Least 50 Percent Reduction in Pain | A responder was a participant with at least 50 percent reduction in average pain scores, using modified BOCF, based on pain intensity (11-point Likert-type numerical scale where 0=no pain and 10=worst possible pain), reported by the subjects in a daily diary. The average pain score for baseline was calculated using the average of the last 7 scores prior to randomization, and the average pain score for Week 15 was computed using the average of the last 7 on-treatment scores prior to Week 15, and they were reported by treatment group. | ITT Population (Modified BOCF) | Posted | Number | Percentage of Participants | Baseline and Week 15 |
| ||||||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Average Pain Scores by Week | Change from baseline in average pain scores by week based on pain intensity (11-point Likert-type numerical scale where 0=no pain and 10=worst possible pain), reported by the subjects in a daily diary. The average pain scores were calculated as the average of available scores in each week, and were reported by treatment group. | ITT Population | Posted | Mean | Standard Deviation | Scores on a scale | Week 1 through Week 16 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 15/EOT in Average Sleep Interference Scores | The average of the last 7 available sleep scores prior to the visit, based on the 11-point Likert-type numerical rating scale for sleep interference (where 0=pain did not interfere with sleep, to 10=pain completely interfered with sleep [unable to sleep]), and they were reported by treatment group. | ITT Population (Modified BOCF) | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and Week 15 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Patient Global Impression of Change (PGIC) at Week 15/EOT | Changes were calculated using the modified BOCF method | Subset of ITT population used, including subjects that completed PGIC at Week 15 visit, and using BOCF (baseline observation carried forward) subjects that terminated prior to Week 15 received a 'No Change' if due to AE or Lack of Therapeutic Efficacy, subjects who discontinued due to other reasons used PGIC scores from Early Termination visit. | Posted | Number | Participants | Week 15 |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Clinician Global Impression of Change (CGIC) at Week 15/EOT | Changes were calculated using the modified BOCF method | Subset of ITT population used, including subjects that completed CGIC at Week 15 visit, and using BOCF (baseline observation carried forward) subjects that terminated prior to Week 15 received a 'No Change' if due to AE or Lack of Therapeutic Efficacy, subjects who discontinued due to other reasons used CGIC scores from Early Termination visit. | Posted | Number | Participants | Week 15 |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 15/EOT in HADS Anxiety Subscale Scores (Modified BOCF) | The HADS (Hospital Anxiety and Depression Scale) is a widely used, self-reported, 14-item instrument that measures the presence and severity of anxiety and depression. It consists of 2 subscales; a 7-item anxiety subscale (HADS-A) and a 7-item depression subscale (HADS-D). HADS-A consists of a 7-item scale, each scored on a 4-pt scale (0, 1, 2, or 3), where a higher score indicates worse anxiety. Range of possible HADS anxiety subscale scores is 0 to 21, and normal=(0-7), mild=(8-10), moderate=(11-14), and severe=(15-21). | ITT population (Modified BOCF) | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and Week 15 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 15/EOT in HADS Depression Subscale Scores (Modified BOCF) | The HADS (Hospital Anxiety and Depression Scale) is a widely used, self-reported, 14-item instrument that measures the presence and severity of anxiety and depression. It consists of 2 subscales; a 7-item anxiety subscale (HADS-A) and a 7-item depression subscale (HADS-D). HADS-D consists of a 7-item scale, each scored on a 4-pt scale (0, 1, 2, or 3), where a higher score indicates worse depression. Range of possible HADS depression subscale scores is 0 to 21, and normal=(0-7), mild=(8-10), moderate=(11-14), and severe=(15-21). | ITT population (Modified BOCF) | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and Week 15 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Analysis of Allodynia (Present/Not Present) at Week 15/EOT- by Treatment Groups ITT Population (Modified BOCF) | Allodynia is defined as a painful reaction to a non-painful stimulus. | ITT population (Modified BOCF) | Posted | Number | Participants | Week 15 |
|
Adverse events (AEs) were collected from the time the patient signed the informed consent form until 30 days after the last dose of study drug.
Safety variables included AEs, laboratory values, vital signs, and electrocardiogram measurements.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo Cohort 1 | Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter) | 1 | 26 | 11 | 26 | ||
| EG001 | Perampanel Cohort 1, 3-week Titration | Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up-titrated at 3-week intervals by 2mg steps to a total of 8mg or MTD [maximum tolerated dose] and continued at this dose until Week 15) | 7 | 53 | 36 | 53 | ||
| EG002 | Placebo Cohort 2 | Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter) | 2 | 22 | 14 | 22 | ||
| EG003 | Perampanel Cohort 2, 1-week Titration | Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up-titrated at 1-week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15) | 1 | 22 | 18 | 22 | ||
| EG004 | Perampanel Cohort 2, 2- Week Titration | Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up-titrated at 2-week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15) | 1 | 23 | 16 | 23 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA V. 11 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA V. 11 | Systematic Assessment |
| |
| Gastric ulcer perforation | Gastrointestinal disorders | MedDRA V. 11 | Systematic Assessment |
| |
| Peritonitis | Gastrointestinal disorders | MedDRA V. 11 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA V. 11 | Systematic Assessment |
| |
| Vestibulitis | General disorders | MedDRA V. 11 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA V. 11 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA V. 11 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA V. 11 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA V. 11 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA V. 11 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA V. 11 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA V. 11 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA V. 11 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA V. 11 | Systematic Assessment |
| |
| Carotid artery occlusion | Nervous system disorders | MedDRA V. 11 | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA V. 11 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA V. 11 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA V. 11 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA V. 11 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA V. 11 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vision blurred | Eye disorders | MedDRA V. 11 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA V. 11 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA V. 11 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA V. 11 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA V. 11 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA V. 11 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA V. 11 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA V. 11 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA V. 11 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA V. 11 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA V. 11 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA V. 11 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA V. 11 | Systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA V. 11 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA V. 11 | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA V. 11 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA V. 11 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA V. 11 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA V. 11 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA V. 11 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA V. 11 | Systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA V. 11 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA V. 11 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eisai Inc. | Eisai Call Center | 888-422-4743 |
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D051474 | Neuralgia, Postherpetic |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C551441 | perampanel |
Not provided
Not provided
Not provided
| ≥65 to <75 years |
|
| ≥75 years |
|
| Male |
|
| Black |
|
| Asian |
|
| Other |
|
Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
| OG003 | Perampanel Cohort 2, 1-week Titration | Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up-titrated at 1-week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15) |
| OG004 | Perampanel Cohort 2, 2- Week Titration | Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up-titrated at 2-week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15) |
|
|
Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
| OG003 | Perampanel Cohort 2, 1-week Titration | Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up-titrated at 1-week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15) |
| OG004 | Perampanel Cohort 2, 2- Week Titration | Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up-titrated at 2-week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15) |
|
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| OG003 | Perampanel Cohort 2, 1-week Titration | Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up-titrated at 1-week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15) |
| OG004 | Perampanel Cohort 2, 2- Week Titration | Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up-titrated at 2-week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15) |
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| OG003 | Perampanel Cohort 2, 1-week Titration | Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up-titrated at 1-week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15) |
| OG004 | Perampanel Cohort 2, 2- Week Titration | Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up-titrated at 2-week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15) |
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| OG003 | Perampanel Cohort 2, 1-week Titration | Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up-titrated at 1-week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15) |
| OG004 | Perampanel Cohort 2, 2- Week Titration | Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up-titrated at 2-week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15) |
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| OG003 | Perampanel Cohort 2, 1-week Titration | Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up-titrated at 1-week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15) |
| OG004 | Perampanel Cohort 2, 2- Week Titration | Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up-titrated at 2-week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15) |
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Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter) |
| OG003 | Perampanel Cohort 2, 1-week Titration | Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up-titrated at 1-week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15) |
| OG004 | Perampanel Cohort 2, 2- Week Titration | Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up-titrated at 2-week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15) |
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Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter) |
| OG003 | Perampanel Cohort 2, 1-week Titration | Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up-titrated at 1-week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15) |
| OG004 | Perampanel Cohort 2, 2- Week Titration | Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up-titrated at 2-week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15) |
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Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up-titrated at 1-week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15) |
| OG004 | Perampanel Cohort 2, 2- Week Titration | Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up-titrated at 2-week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15) |
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