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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-005495-13 | EudraCT Number |
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The purpose of this study is to evaluate the safety, tolerability and continued efficacy of perampanel in patients previously enrolled in double-blind, placebo-controlled studies for Painful Diabetic Neuropathy (PDN) or Post-Herpetic Neuralgia (PHN).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E2007 | Drug | Perampanel doses will be up-titrated in 2 mg steps at minimum weekly intervals starting at 2 mg daily and up-titrated to 12 mg daily (taken orally). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Short Form-McGill Pain Questionnaire (SF-MPQ): Sensory and Affective Scores, From Baseline to Week 48. | Mean change from baseline to open-label study endpoint and other study visits in SF-MPQ scores sensory and affective). SF-MPQ was completed to assess intensity of pain over the past 48 days for all 15 descriptors: throbbing, shooting, stabbing, sharp, cramping, gnawing, hot-burning, aching, heavy, tender, splitting,tiring-exhausting, sickening, fear-causing, punishing-cruel. Each descriptor was scored by participant on a 4-point intensity scale (0=none to 3=severe) and totaled in each subclass (sensory range 0-45); higher scores indicated higher intensity of pain. | Baseline and Week 48 |
| Mean Change From Baseline in SF-MPQ Visual Analog Scale (VAS): From Baseline to Week 48. | SF-MPQ VAS consists of a line 0 to 100 millimeters (mm) in length; range is 0 (no pain) to 100 mm (worst possible pain). Subjects placed a mark indicating the intensity of their pain. Distance from left-hand end of line was measured and entered on Case Report Form (CRF) as score in mm. Higher score indicates greater level of pain. | Baseline and Week 48 |
| Mean Change From Baseline in SF-MPQ Current Pain Intensity (CPI): From Baseline to Week 48 | Mean change from baseline in SF-MPQ (CPI) at study endpoint. Affective score ranges from 0-5. Higher scores indicate more severe pain (0=no pain, 1=mild, 2=discomforting, 3=distressing, 4=horrible, 5=excrutiating). | Baseline and Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of Patient Global Impression of Change (PGIC) at Week 48/End of Treatment (EOT) | The PGIC asked subjects to evaluate the change in their overall status compared with the start of open-label treatment on a scale ranging from 1 (very much improved) to 7 (very much worse). [Please note high withdrawl rate during study]. | Baseline and Week 48 |
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Inclusion Criteria:
Each patient must meet all of the following criteria to be enrolled in this study:
Exclusion Criteria:
Patients who meet the following criterion will be excluded from this study:
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Laurenza, M. D. | Eisai Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chicago | Illinois | 60610 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Painful Diabetic Neuropathy (PDN): Prior Treatment of Placebo | All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally once daily (QD), depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN. |
| FG001 | PDN: Prior Treatment of Perampanel | All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN. |
| FG002 | Post Herpetic Neuralgia (PHN): Prior Treatment of Placebo | All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN. |
| FG003 | PHN: Prior Treatment of Perampanel | All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Painful Diabetic Neuropathy (PDN): Prior Treatment of Placebo | All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally once daily (QD), depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Mean Change From Baseline in Short Form-McGill Pain Questionnaire (SF-MPQ): Sensory and Affective Scores, From Baseline to Week 48. | Mean change from baseline to open-label study endpoint and other study visits in SF-MPQ scores sensory and affective). SF-MPQ was completed to assess intensity of pain over the past 48 days for all 15 descriptors: throbbing, shooting, stabbing, sharp, cramping, gnawing, hot-burning, aching, heavy, tender, splitting,tiring-exhausting, sickening, fear-causing, punishing-cruel. Each descriptor was scored by participant on a 4-point intensity scale (0=none to 3=severe) and totaled in each subclass (sensory range 0-45); higher scores indicated higher intensity of pain. | Intent-to-Treat (ITT) Population: All enrolled subjects (starting at Visit 1) who took at least 1 dose of study drug and had at least 1 efficacy assessment in this trial comprised the ITT Population. All efficacy analyses were performed on the ITT Population. One subject had a protocol violation after consenting and was withdrawn from treatment. | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline and Week 48 |
|
Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
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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 | The participants who had previously received placebo during the double-blind study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA V. 11.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA V. 11.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eisai Inc. | Eisai Call Center | 888-422-4743 |
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| ID | Term |
|---|---|
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
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| ID | Term |
|---|---|
| C551441 | perampanel |
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| Mean Change From Baseline in Short Form 36 Item (SF-36) Health Survey: Physical and Mental Component Scores From Baseline to Week 48/EOT | Mean change from baseline in SF-36 Item Health Survey Scores at study endpoint. Each component on the SF-36 Item Health Survey is scored from 0-100 with higher scores reflecting better subject status. | Baseline and Week 48 |
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Lack of Efficacy |
|
| Physician Decision |
|
| Other |
|
| BG001 | PDN: Prior Treatment of Perampanel | All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN. |
| BG002 | Post Herpetic Neuralgia (PHN): Prior Treatment of Placebo | All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN. |
| BG003 | PHN: Prior Treatment of Perampanel | All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Race | Number | Participants |
|
| Description |
|---|
| OG000 | Painful Diabetic Neuropathy (PDN): Prior Treatment of Placebo | All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally once daily (QD), depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN. |
| OG001 | PDN: Prior Treatment of Perampanel | All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN. |
| OG002 | Post Herpetic Neuralgia (PHN): Prior Treatment of Placebo | All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN. |
| OG003 | PHN: Prior Treatment of Perampanel | All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN. |
|
|
| Primary | Mean Change From Baseline in SF-MPQ Visual Analog Scale (VAS): From Baseline to Week 48. | SF-MPQ VAS consists of a line 0 to 100 millimeters (mm) in length; range is 0 (no pain) to 100 mm (worst possible pain). Subjects placed a mark indicating the intensity of their pain. Distance from left-hand end of line was measured and entered on Case Report Form (CRF) as score in mm. Higher score indicates greater level of pain. | ITT Population | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline and Week 48 |
|
|
|
| Primary | Mean Change From Baseline in SF-MPQ Current Pain Intensity (CPI): From Baseline to Week 48 | Mean change from baseline in SF-MPQ (CPI) at study endpoint. Affective score ranges from 0-5. Higher scores indicate more severe pain (0=no pain, 1=mild, 2=discomforting, 3=distressing, 4=horrible, 5=excrutiating). | ITT Population | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline and Week 48 |
|
|
|
| Secondary | Analysis of Patient Global Impression of Change (PGIC) at Week 48/End of Treatment (EOT) | The PGIC asked subjects to evaluate the change in their overall status compared with the start of open-label treatment on a scale ranging from 1 (very much improved) to 7 (very much worse). [Please note high withdrawl rate during study]. | 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 | Baseline and Week 48 |
|
|
|
| Secondary | Mean Change From Baseline in Short Form 36 Item (SF-36) Health Survey: Physical and Mental Component Scores From Baseline to Week 48/EOT | Mean change from baseline in SF-36 Item Health Survey Scores at study endpoint. Each component on the SF-36 Item Health Survey is scored from 0-100 with higher scores reflecting better subject status. | ITT Population | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline and Week 48 |
|
|
|
| 11 |
| 84 |
| 72 |
| 84 |
| EG001 | Perampanel | The participants that had previously received perampanel during the double-blind study. | 25 | 178 | 132 | 178 |
| EG002 | Painful Diabetic Neuropathy | The participants that were being treated for PDN in the double-blind study and received either placebo or perampanel. | 31 | 205 | 160 | 205 |
| EG003 | Post Herpetic Neuralgia | The participants that were being treated for PHN in the double-blind study and received either placebo or perampanel. | 5 | 57 | 44 | 57 |
| Arrhythmia | Cardiac disorders | MedDRA V. 11.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA V. 11.0 | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA V. 11.0 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA V. 11.0 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA V. 11.0 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA V. 11.0 | Systematic Assessment |
|
| Cor pulmonale | Cardiac disorders | MedDRA V. 11.0 | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA V. 11.0 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA V. 11.0 | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA V. 11.0 | Systematic Assessment |
|
| Tachycardia paroxysmal | Cardiac disorders | MedDRA V. 11.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA V. 11.0 | Systematic Assessment |
|
| Large intestinal ulcer | Gastrointestinal disorders | MedDRA V. 11.0 | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA V. 11.0 | Systematic Assessment |
|
| Arthritis bacterial | Infections and infestations | MedDRA V. 11.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA V. 11.0 | Systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA V. 11.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA V. 11.0 | Systematic Assessment |
|
| Osteomyelitis | Infections and infestations | MedDRA V. 11.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA V. 11.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA V. 11.0 | Systematic Assessment |
|
| Subcutaneous abscess | Infections and infestations | MedDRA V. 11.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA V. 11.0 | Systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA V. 11.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA V. 11.0 | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA V. 11.0 | Systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA V. 11.0 | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA V. 11.0 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA V. 11.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA V. 11.0 | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA V. 11.0 | Systematic Assessment |
|
| Neuropathic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA V. 11.0 | Systematic Assessment |
|
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V. 11.0 | Systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V. 11.0 | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V. 11.0 | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V. 11.0 | Systematic Assessment |
|
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V. 11.0 | Systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V. 11.0 | Systematic Assessment |
|
| Ataxia | Nervous system disorders | MedDRA V. 11.0 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA V. 11.0 | Systematic Assessment |
|
| Dementia | Nervous system disorders | MedDRA V. 11.0 | Systematic Assessment |
|
| Speech disorder | Nervous system disorders | MedDRA V. 11.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA V. 11.0 | Systematic Assessment |
|
| Toxic encephalopathy | Nervous system disorders | MedDRA V. 11.0 | Systematic Assessment |
|
| Vascular encephalopathy | Nervous system disorders | MedDRA V. 11.0 | Systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedDRA V. 11.0 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA V. 11.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA V. 11.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA V. 11.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA V. 11.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA V. 11.0 | Systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA V. 11.0 | Systematic Assessment |
|
| Irritability | General disorders | MedDRA V. 11.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA V. 11.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA V. 11.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA V. 11.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA V. 11.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA V. 11.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA V. 11.0 | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA V. 11.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA V. 11.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA V. 11.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA V. 11.0 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA V. 11.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA V. 11.0 | Systematic Assessment |
|
| Ataxia | Nervous system disorders | MedDRA V. 11.0 | Systematic Assessment |
|
| Balance disorder | Nervous system disorders | MedDRA V. 11.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA V. 11.0 | Systematic Assessment |
|
| Dysarthria | Nervous system disorders | MedDRA V. 11.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA V. 11.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA V. 11.0 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA V. 11.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA V. 11.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA V. 11.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA V. 11.0 | Systematic Assessment |
|
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Much improved (2) |
|
| Minimally improved (3) |
|
| No change (4) |
|
| Minimally worse (5) |
|
| Much worse (6) |
|
| Very much worse (7) |
|
| Mental Component Score |
|