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| ID | Type | Description | Link |
|---|---|---|---|
| 2004-000361-35 | EudraCT Number |
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Due to termination of clinical program for Parkinson's Disease
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A 48-month open label multi-centered extension study to evaluate the long-term safety, tolerability and efficacy of E2007 in patients with Parkinson's Disease with "wearing off" motor fluctuations and "on" period Dyskinesias.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perampanel (1-4 mg) | Experimental | Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204), and dosed placebo or perampanel. Subjects started this open-label extension study on perampanel 1 mg once daily for two weeks, followed by 2 mg once daily for two weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perampanel | Drug | 1mg once daily for two weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study | OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor. This outcome measure was based on data collected through use of a patient diary. | Baseline, Week 0, Week 12, Week 24, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) During Open-label Extension Study | ON state is when medication is providing benefits with regard to stiffness, slowness, and tremor. This outcome measure was based on data collected through use of a patient diary. | Baseline, Week 0, Week 12, Week 24, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | Perampanel (Placebo During Core Study) | Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner. |
| FG001 | Perampanel (Perampanel 0.5, 1, or 2 mg During Core Study) | Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Perampanel (Placebo During Core Study) | Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner. |
| 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 |
| 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 Total Daily OFF Time (Hours) During Open-label Extension Study | OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor. This outcome measure was based on data collected through use of a patient diary. | Efficacy Population- All subjects who were in the Safety Population and for whom at least 1 postbaseline (post Week 0) efficacy assessment was made. | Posted | Mean | Standard Deviation | Hours | Baseline, Week 0, Week 12, Week 24, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156 |
|
Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
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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 | Perampanel (Placebo During Core Study) | Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyskinesia | Nervous system disorders | MedDRA version 11.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Muscle Rigidity | Musculoskeletal and connective tissue disorders | MedDRA version 11.0 | Systematic Assessment |
Due to early termination, no subjects completed this open-label extension study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eisai Inc. | Eisai Call Center | 888-422-4743 |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C551441 | perampanel |
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|
|
| Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) During Open- Label Extension Study | Unified Parkinson's Disease Rating Scale (UPDRS) is a standardized assessment of the symptoms and signs of Parkinson's Disease. Part III assesses motor activity, based on 14 items, such as gait, facial expression, and rigidity. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms. Range of possible total scores, 0 to 56. ON state is when medication is providing benefits with regard to stiffness, slowness, and tremor. | Baseline, Week 0, Week 12, Week 24, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156 |
| Protocol Violation |
|
| Lack of Efficacy |
|
| Other |
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| Study termination by sponsor |
|
| BG001 | Perampanel (Perampanel 0.5, 1, or 2 mg During Core Study) | Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | The participant flow information was collected from all participants who entered the study. Baseline information was collected only for the safety population (all subjects who received at least 1 dose of perampanel in this study and at least 1 dose of study medication during the double-blind phase of the core study). | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Race | Number | Participants |
|
| OG001 | Perampanel (Perampanel 0.5, 1, or 2 mg During Core Study) | Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner. |
|
|
| Secondary | Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) During Open-label Extension Study | ON state is when medication is providing benefits with regard to stiffness, slowness, and tremor. This outcome measure was based on data collected through use of a patient diary. | Efficacy Population | Posted | Mean | Standard Deviation | Hours | Baseline, Week 0, Week 12, Week 24, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156 |
|
|
|
| Secondary | Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) During Open- Label Extension Study | Unified Parkinson's Disease Rating Scale (UPDRS) is a standardized assessment of the symptoms and signs of Parkinson's Disease. Part III assesses motor activity, based on 14 items, such as gait, facial expression, and rigidity. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms. Range of possible total scores, 0 to 56. ON state is when medication is providing benefits with regard to stiffness, slowness, and tremor. | Efficacy Population | Posted | Mean | Standard Deviation | Scores on scale | Baseline, Week 0, Week 12, Week 24, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156 |
|
|
|
| 13 |
| 48 |
| 3 |
| 48 |
| EG001 | Perampanel (Perampanel 0.5, 1, or 2 mg During Core Study) | Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner. | 39 | 134 | 0 | 134 |
| On and off phenomenon | Nervous system disorders | MedDRA version 11.0 | Systematic Assessment |
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| Dementia | Nervous system disorders | MedDRA version 11.0 | Systematic Assessment |
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| Balance disorder | Nervous system disorders | MedDRA version 11.0 | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA version 11.0 | Systematic Assessment |
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| Dystonia | Nervous system disorders | MedDRA version 11.0 | Systematic Assessment |
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| Freezing phenomenon | Nervous system disorders | MedDRA version 11.0 | Systematic Assessment |
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| Hyperkinesia | Nervous system disorders | MedDRA version 11.0 | Systematic Assessment |
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| Paraparesis | Nervous system disorders | MedDRA version 11.0 | Systematic Assessment |
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| Psycomotor hyperactivity | Nervous system disorders | MedDRA version 11.0 | Systematic Assessment |
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| Sciatica | Nervous system disorders | MedDRA version 11.0 | Systematic Assessment |
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| Transient ischemic attack | Nervous system disorders | MedDRA version 11.0 | Systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA version 11.0 | Systematic Assessment |
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| Muscle rigidity | Musculoskeletal and connective tissue disorders | MedDRA version 11.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 11.0 | Systematic Assessment |
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| Posture abnormal | Musculoskeletal and connective tissue disorders | MedDRA version 11.0 | Systematic Assessment |
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| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA version 11.0 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA version 11.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 11.0 | Systematic Assessment |
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| Sensation of heaviness | Musculoskeletal and connective tissue disorders | MedDRA version 11.0 | Systematic Assessment |
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| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA version 11.0 | Systematic Assessment |
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| Hallucination | Psychiatric disorders | MedDRA version 11.0 | Systematic Assessment |
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| Confusional state | Psychiatric disorders | MedDRA version 11.0 | Systematic Assessment |
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| Hallucination, visual | Psychiatric disorders | MedDRA version 11.0 | Systematic Assessment |
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| Psychotic disorder | Psychiatric disorders | MedDRA version 11.0 | Systematic Assessment |
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| Delirium | Psychiatric disorders | MedDRA version 11.0 | Systematic Assessment |
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| Delusion | Psychiatric disorders | MedDRA version 11.0 | Systematic Assessment |
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| Dissociation | Psychiatric disorders | MedDRA version 11.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA version 11.0 | Systematic Assessment |
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| Hip fracture | Injury, poisoning and procedural complications | MedDRA version 11.0 | Systematic Assessment |
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| Device malfunction | Injury, poisoning and procedural complications | MedDRA version 11.0 | Systematic Assessment |
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| Femur fracture | Injury, poisoning and procedural complications | MedDRA version 11.0 | Systematic Assessment |
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| Head injury | Injury, poisoning and procedural complications | MedDRA version 11.0 | Systematic Assessment |
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| Humerous fracture | Injury, poisoning and procedural complications | MedDRA version 11.0 | Systematic Assessment |
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| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA version 11.0 | Systematic Assessment |
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| Radial nerve injury | Injury, poisoning and procedural complications | MedDRA version 11.0 | Systematic Assessment |
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| Spinal fracture | Injury, poisoning and procedural complications | MedDRA version 11.0 | Systematic Assessment |
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| Ulna fracture | Injury, poisoning and procedural complications | MedDRA version 11.0 | Systematic Assessment |
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| Benign ovarian tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 11.0 | Systematic Assessment |
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| Gastrointestinal stromal tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 11.0 | Systematic Assessment |
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| Prostrate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 11.0 | Systematic Assessment |
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| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 11.0 | Systematic Assessment |
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| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 11.0 | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA version 11.0 | Systematic Assessment |
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| Arterial stenosis limb | Vascular disorders | MedDRA version 11.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA version 11.0 | Systematic Assessment |
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| Orthostatic hypotension | Vascular disorders | MedDRA version 11.0 | Systematic Assessment |
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| Angina unstable | Cardiac disorders | MedDRA version 11.0 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA version 11.0 | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA version 11.0 | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA version 11.0 | Systematic Assessment |
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| Gait disturbance | General disorders | MedDRA version 11.0 | Systematic Assessment |
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| General physical health deterioration | General disorders | MedDRA version 11.0 | Systematic Assessment |
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| Hernia | General disorders | MedDRA version 11.0 | Systematic Assessment |
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| Sudden death | General disorders | MedDRA version 11.0 | Systematic Assessment |
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| Infection | Infections and infestations | MedDRA version 11.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA version 11.0 | Systematic Assessment |
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| Blood alkaline phosphatase | Investigations | MedDRA version 11.0 | Systematic Assessment |
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| Blood pressure decrease | Investigations | MedDRA version 11.0 | Systematic Assessment |
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| Heamatocrit decreased | Investigations | MedDRA version 11.0 | Systematic Assessment |
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| Investigation | Investigations | MedDRA version 11.0 | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA version 11.0 | Systematic Assessment |
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| Epigastric discomfort | Gastrointestinal disorders | MedDRA version 11.0 | Systematic Assessment |
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| Inguinal hernia | Gastrointestinal disorders | MedDRA version 11.0 | Systematic Assessment |
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| Obstructive uropathy | Renal and urinary disorders | MedDRA version 11.0 | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA version 11.0 | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA version 11.0 | Systematic Assessment |
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| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA version 11.0 | Systematic Assessment |
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| Social stay hospitalisation | Social circumstances | MedDRA version 11.0 | Systematic Assessment |
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| Deep brain stimulation | Surgical and medical procedures | MedDRA version 11.0 | Systematic Assessment |
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| Knee arthroplasty | Surgical and medical procedures | MedDRA version 11.0 | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA version 11.0 | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA version 11.0 | Systematic Assessment |
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| Cachexia | Metabolism and nutrition disorders | MedDRA version 11.0 | Systematic Assessment |
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| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA version 11.0 | Systematic Assessment |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| Week 24 |
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| Week 36 |
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| Week 52 |
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| Week 78 |
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| Week 104 |
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| Week 130 |
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| Week 156 |
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| Week 24 |
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| Week 36 |
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| Week 52 |
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| Week 78 |
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| Week 104 |
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| Week 130 |
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| Week 156 |
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