Parkinson's Disease
Conditions
Brief summary
Patients who have completed one of the core trials (E2007-E044-301 or E2007-A001-302) and who meet inclusion/exclusion criteria will be enrolled and will enter the Titration Phase, lasting 4 weeks (weeks 0-3) followed by the Maintenance Phase, lasting 52 weeks (weeks 4-56). All patients will receive active study drug. During the Titration Phase, patients will receive E2007 2 mg once daily (o.d.) for 2 weeks followed by 4 mg o.d. for 2 weeks. During the Maintenance Phase, patients will receive 4 mg o.d. Patients not tolerating the study drug at 4 mg, will be allowed to down titrate to 2 mg. Patients not tolerating 2 mg will be withdrawn from the study. Patients will have visits at 2, 4, 8, 20, 32, 44, and 56 weeks after study entry. In addition, a follow-up visit will occur 4 weeks after study treatment has ended (week 60). A home diary will be completed in which patients rate themselves as either: 1. OFF 2. ON without dyskinesia 3. ON with non-troublesome dyskinesias 4. ON with troublesome dyskinesias 5. Asleep These entries will be completed every half hour during the waking day and will be completed for 3 consecutive days following the visits at weeks 4, 8, 20, 32 and 44, and three days prior to the visits at weeks 56 and 60. At entry into the study (week 0) and at weeks 8, 20, 32, 44 and 56, the Unified Parkinson's Disease Rating Scale (UPDRS), Clinician's Global Impression of Change (CGIC) and Clinical Global Impression of Tolerance (CGIT) will be performed.
Interventions
DRUGE2007
Sponsors
Eisai Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Male or female patients with idiopathic PD who have fulfilled the entry criteria to either E2007-E044-301 or E2007-A001-302 and have completed that study up to and including the final efficacy visit. Patients will not be eligible if they withdrew from the core study prior to the final efficacy visit for any reason including lack of efficacy. Patients with SAEs which are ongoing or possibly or probably related to the study drug, will not be eligible for this study. Patients with ongoing adverse events categorized as severe and thought to be related to E2007 should not be entered. Patients with mild or moderate adverse events thought to be related to E2007 can be entered to the study if the investigator considers it safe.
Exclusion criteria
1. Pregnant or lactating women. 2. Women of child bearing potential unless infertile (including surgically sterile) or practicing effective contraception (e.g., abstinence, IUD or barrier method plus hormonal method). These patients must have a negative serum or urine B-HCG test at their first study visit. These patients must also be willing to remain on their current form of contraception for the duration of the study. Postmenopausal women may be recruited but must be amenorrhoeic for at least 1 year to be considered of non-child bearing potential as determined by the investigator. 3. Patients with a past (within the past 5 years) or present history of drug or alcohol abuse as per DSM IV criteria. 4. Patients with a past (within one year) or present history of suicidal ideation or suicide attempts. 5. Patients with a past (within one year) or present history of psychotic symptoms requiring antipsychotic treatment. Patients may be taking anti-depressant medication, however the dose must be stable for 4 weeks prior to the baseline visit. Use of anti-psychotic medication including clozapine and quetiapine is prohibited even if the indication is for movement disorders. 6. Patients with unstable abnormalities of the hepatic, renal, cardiovascular, respiratory, gastro-intestinal, haematological, endocrine or metabolic systems which might complicate assessment of the tolerability of the study medication. 7. Patients with significantly elevated liver enzymes (abnormal bilirubin or serum transaminase levels of more than 1.5 times the upper normal limit). 8. Medication known to induce the enzyme cytochrome P450 3A4 is prohibited throughout the study. 9. Current or prior treatment (within 4 weeks prior to entry visit) with tolcapone, methyldopa, budipine, reserpine, seroquel. 10. Patients with conditions affecting the peripheral or central sensory system unless related to Parkinson's disease (such as mild sensory or pain syndromes limited to OFF periods) that could interfere with the evaluation of any such symptoms caused by the study drug. 11. Patients receiving or with planned (next 12 months) deep brain stimulation. 12. Patients with any condition that would make the patient, in the opinion of the Investigator, unsuitable for the study. 13. Patients with clinically significant ECG abnormalities, including prolonged QTc (defined as QTc ≥ 450 msec). 14. Patients with previous stereotactic surgery (e.g., pallidotomy) for Parkinson's disease or with planned stereotactic surgery during the study period. 15. Patients on pergolide as of April 5, 2007.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study | Baseline, Week 0, Week 4, Week 8, Week 20, Week 32, Week 44, Week 56, Week 68 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) During Open-label Extension Study | Baseline, Week 0, Week 4, Week 8, Week 20, Week 32, Week 44, Week 56, Week 68 | 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. |
| Mean Change From Baseline in UPDRS Part II (ADL) Score in OFF State (Hours) During Open-label Extension Study | Baseline, Week 0, Week, 8, Week 20, Week 32, Week 44, Week 56, Week 68 | Unified Parkinson's Disease Rating Scale (UPDRS) is a standardized assessment of the symptoms and signs of Parkinson's Disease. Part II assesses activities of daily living (ADL) based on 13 items, such as speech, hygiene, and falling. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms, for a range of total possible scores of 0-52. OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor. |
| Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) During Open- Label Extension Study | Baseline, Week 0, Week 8, Week 20, Week 32, Week 44, Week 56, Week 68 | 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, for a range of total possible scores of 0-56. ON state is when medication is providing benefits with regard to stiffness, slowness, and tremor. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Perampanel (Placebo During Core Study) Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study. | 333 |
| Perampanel (Perampanel 2 mg or 4 mg During Core Study) Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study. | 664 |
| Total | 997 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 37 | 65 |
| Overall Study | Lack of therapeutic efficacy | 46 | 61 |
| Overall Study | Other | 5 | 6 |
| Overall Study | Patient withdrew consent | 27 | 52 |
| Overall Study | Physician Decision | 2 | 4 |
| Overall Study | Protocol Violation | 2 | 5 |
| Overall Study | Study termination by Sponsor | 214 | 469 |
Baseline characteristics
| Characteristic | Total | Perampanel (Placebo During Core Study) | Perampanel (Perampanel 2 mg or 4 mg During Core Study) |
|---|---|---|---|
| Age, Customized <65 years | 544 Participants | 187 Participants | 357 Participants |
| Age, Customized >=65 years | 453 Participants | 146 Participants | 307 Participants |
| Race/Ethnicity, Customized Asian | 6 Participants | 4 Participants | 2 Participants |
| Race/Ethnicity, Customized Black | 7 Participants | 3 Participants | 4 Participants |
| Race/Ethnicity, Customized Other | 21 Participants | 6 Participants | 15 Participants |
| Race/Ethnicity, Customized White | 963 Participants | 320 Participants | 643 Participants |
| Sex: Female, Male Female | 353 Participants | 117 Participants | 236 Participants |
| Sex: Female, Male Male | 644 Participants | 216 Participants | 428 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 104 / 333 | 201 / 664 |
| serious Total, serious adverse events | 33 / 333 | 57 / 664 |
Outcome results
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.
Time frame: Baseline, Week 0, Week 4, Week 8, Week 20, Week 32, Week 44, Week 56, Week 68
Population: Safety Population- all subjects entering the open-label extension study who took at least 1 dose of perampanel
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Perampanel (Placebo During Core Study) | Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study | Week 0 | -0.78 Hours | Standard Deviation 2.158 |
| Perampanel (Placebo During Core Study) | Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study | Week 4 | -1.37 Hours | Standard Deviation 2.483 |
| Perampanel (Placebo During Core Study) | Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study | Week 8 | -1.21 Hours | Standard Deviation 2.4 |
| Perampanel (Placebo During Core Study) | Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study | Week 20 | -1.11 Hours | Standard Deviation 2.537 |
| Perampanel (Placebo During Core Study) | Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study | Week 32 | -0.91 Hours | Standard Deviation 2.663 |
| Perampanel (Placebo During Core Study) | Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study | Week 44 | -0.73 Hours | Standard Deviation 2.371 |
| Perampanel (Placebo During Core Study) | Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study | Week 56 | -0.64 Hours | Standard Deviation 2.607 |
| Perampanel (Placebo During Core Study) | Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study | week 68 | -0.92 Hours | Standard Deviation 2.239 |
| Perampanel (Perampanel 2 mg or 4 mg During Core Study) | Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study | week 68 | -1.05 Hours | Standard Deviation 1.82 |
| Perampanel (Perampanel 2 mg or 4 mg During Core Study) | Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study | Week 0 | -0.85 Hours | Standard Deviation 2.498 |
| Perampanel (Perampanel 2 mg or 4 mg During Core Study) | Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study | Week 32 | -1.38 Hours | Standard Deviation 2.676 |
| Perampanel (Perampanel 2 mg or 4 mg During Core Study) | Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study | Week 4 | -1.16 Hours | Standard Deviation 2.632 |
| Perampanel (Perampanel 2 mg or 4 mg During Core Study) | Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study | Week 56 | -0.78 Hours | Standard Deviation 2.01 |
| Perampanel (Perampanel 2 mg or 4 mg During Core Study) | Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study | Week 8 | -1.19 Hours | Standard Deviation 2.568 |
| Perampanel (Perampanel 2 mg or 4 mg During Core Study) | Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study | Week 44 | -1.44 Hours | Standard Deviation 2.47 |
| Perampanel (Perampanel 2 mg or 4 mg During Core Study) | Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study | Week 20 | -1.34 Hours | Standard Deviation 2.694 |
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.
Time frame: Baseline, Week 0, Week 4, Week 8, Week 20, Week 32, Week 44, Week 56, Week 68
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Perampanel (Placebo During Core Study) | Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) During Open-label Extension Study | Week 0 | 0.73 Hours | Standard Deviation 2.389 |
| Perampanel (Placebo During Core Study) | Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) During Open-label Extension Study | Week 32 | 0.77 Hours | Standard Deviation 2.716 |
| Perampanel (Placebo During Core Study) | Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) During Open-label Extension Study | Week 8 | 0.82 Hours | Standard Deviation 2.741 |
| Perampanel (Placebo During Core Study) | Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) During Open-label Extension Study | Week 44 | 0.60 Hours | Standard Deviation 2.742 |
| Perampanel (Placebo During Core Study) | Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) During Open-label Extension Study | Week 4 | 1.02 Hours | Standard Deviation 2.664 |
| Perampanel (Placebo During Core Study) | Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) During Open-label Extension Study | Week 20 | 0.95 Hours | Standard Deviation 2.811 |
| Perampanel (Placebo During Core Study) | Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) During Open-label Extension Study | Week 68 | 0.50 Hours | Standard Deviation 2.121 |
| Perampanel (Placebo During Core Study) | Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) During Open-label Extension Study | Week 56 | 0.40 Hours | Standard Deviation 2.596 |
| Perampanel (Perampanel 2 mg or 4 mg During Core Study) | Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) During Open-label Extension Study | Week 68 | 0.21 Hours | Standard Deviation 1.539 |
| Perampanel (Perampanel 2 mg or 4 mg During Core Study) | Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) During Open-label Extension Study | Week 0 | 0.65 Hours | Standard Deviation 2.567 |
| Perampanel (Perampanel 2 mg or 4 mg During Core Study) | Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) During Open-label Extension Study | Week 4 | 0.98 Hours | Standard Deviation 2.665 |
| Perampanel (Perampanel 2 mg or 4 mg During Core Study) | Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) During Open-label Extension Study | Week 8 | 0.96 Hours | Standard Deviation 2.801 |
| Perampanel (Perampanel 2 mg or 4 mg During Core Study) | Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) During Open-label Extension Study | Week 20 | 1.14 Hours | Standard Deviation 2.803 |
| Perampanel (Perampanel 2 mg or 4 mg During Core Study) | Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) During Open-label Extension Study | Week 32 | 1.05 Hours | Standard Deviation 2.695 |
| Perampanel (Perampanel 2 mg or 4 mg During Core Study) | Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) During Open-label Extension Study | Week 44 | 0.98 Hours | Standard Deviation 2.634 |
| Perampanel (Perampanel 2 mg or 4 mg During Core Study) | Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) During Open-label Extension Study | Week 56 | 0.02 Hours | Standard Deviation 2.132 |
Secondary
Mean Change From Baseline in UPDRS Part II (ADL) Score in OFF 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 II assesses activities of daily living (ADL) based on 13 items, such as speech, hygiene, and falling. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms, for a range of total possible scores of 0-52. OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor.
Time frame: Baseline, Week 0, Week, 8, Week 20, Week 32, Week 44, Week 56, Week 68
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Perampanel (Placebo During Core Study) | Mean Change From Baseline in UPDRS Part II (ADL) Score in OFF State (Hours) During Open-label Extension Study | Week 20 | -0.38 Scores on a scale | Standard Deviation 4.667 |
| Perampanel (Placebo During Core Study) | Mean Change From Baseline in UPDRS Part II (ADL) Score in OFF State (Hours) During Open-label Extension Study | Week 44 | -0.22 Scores on a scale | Standard Deviation 5.217 |
| Perampanel (Placebo During Core Study) | Mean Change From Baseline in UPDRS Part II (ADL) Score in OFF State (Hours) During Open-label Extension Study | Week 8 | -0.31 Scores on a scale | Standard Deviation 4.752 |
| Perampanel (Placebo During Core Study) | Mean Change From Baseline in UPDRS Part II (ADL) Score in OFF State (Hours) During Open-label Extension Study | Week 56 | -1.00 Scores on a scale | Standard Deviation 5.228 |
| Perampanel (Placebo During Core Study) | Mean Change From Baseline in UPDRS Part II (ADL) Score in OFF State (Hours) During Open-label Extension Study | Week 32 | 0.07 Scores on a scale | Standard Deviation 5.018 |
| Perampanel (Placebo During Core Study) | Mean Change From Baseline in UPDRS Part II (ADL) Score in OFF State (Hours) During Open-label Extension Study | Week 68 | -3.00 Scores on a scale | Standard Deviation 0 |
| Perampanel (Placebo During Core Study) | Mean Change From Baseline in UPDRS Part II (ADL) Score in OFF State (Hours) During Open-label Extension Study | Week 0 | -0.36 Scores on a scale | Standard Deviation 4.035 |
| Perampanel (Perampanel 2 mg or 4 mg During Core Study) | Mean Change From Baseline in UPDRS Part II (ADL) Score in OFF State (Hours) During Open-label Extension Study | Week 68 | 2.43 Scores on a scale | Standard Deviation 5.623 |
| Perampanel (Perampanel 2 mg or 4 mg During Core Study) | Mean Change From Baseline in UPDRS Part II (ADL) Score in OFF State (Hours) During Open-label Extension Study | Week 0 | -0.39 Scores on a scale | Standard Deviation 4.567 |
| Perampanel (Perampanel 2 mg or 4 mg During Core Study) | Mean Change From Baseline in UPDRS Part II (ADL) Score in OFF State (Hours) During Open-label Extension Study | Week 8 | -0.60 Scores on a scale | Standard Deviation 4.797 |
| Perampanel (Perampanel 2 mg or 4 mg During Core Study) | Mean Change From Baseline in UPDRS Part II (ADL) Score in OFF State (Hours) During Open-label Extension Study | Week 20 | -0.36 Scores on a scale | Standard Deviation 5.152 |
| Perampanel (Perampanel 2 mg or 4 mg During Core Study) | Mean Change From Baseline in UPDRS Part II (ADL) Score in OFF State (Hours) During Open-label Extension Study | Week 32 | -0.12 Scores on a scale | Standard Deviation 5.436 |
| Perampanel (Perampanel 2 mg or 4 mg During Core Study) | Mean Change From Baseline in UPDRS Part II (ADL) Score in OFF State (Hours) During Open-label Extension Study | Week 44 | -0.25 Scores on a scale | Standard Deviation 5.39 |
| Perampanel (Perampanel 2 mg or 4 mg During Core Study) | Mean Change From Baseline in UPDRS Part II (ADL) Score in OFF State (Hours) During Open-label Extension Study | Week 56 | 0.38 Scores on a scale | Standard Deviation 6.171 |
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, for a range of total possible scores of 0-56. ON state is when medication is providing benefits with regard to stiffness, slowness, and tremor.
Time frame: Baseline, Week 0, Week 8, Week 20, Week 32, Week 44, Week 56, Week 68
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Perampanel (Placebo During Core Study) | Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) During Open- Label Extension Study | Week 20 | -2.48 Scores on a scale | Standard Deviation 7.425 |
| Perampanel (Placebo During Core Study) | Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) During Open- Label Extension Study | Week 44 | -2.23 Scores on a scale | Standard Deviation 8.428 |
| Perampanel (Placebo During Core Study) | Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) During Open- Label Extension Study | Week 8 | -3.17 Scores on a scale | Standard Deviation 7.712 |
| Perampanel (Placebo During Core Study) | Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) During Open- Label Extension Study | Week 56 | -1.91 Scores on a scale | Standard Deviation 7.77 |
| Perampanel (Placebo During Core Study) | Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) During Open- Label Extension Study | Week 32 | -2.86 Scores on a scale | Standard Deviation 8.501 |
| Perampanel (Placebo During Core Study) | Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) During Open- Label Extension Study | Week 68 | -7.00 Scores on a scale | Standard Deviation 0 |
| Perampanel (Placebo During Core Study) | Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) During Open- Label Extension Study | Week 0 | -1.92 Scores on a scale | Standard Deviation 6.945 |
| Perampanel (Perampanel 2 mg or 4 mg During Core Study) | Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) During Open- Label Extension Study | Week 68 | -1.29 Scores on a scale | Standard Deviation 6.775 |
| Perampanel (Perampanel 2 mg or 4 mg During Core Study) | Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) During Open- Label Extension Study | Week 0 | -1.87 Scores on a scale | Standard Deviation 7.518 |
| Perampanel (Perampanel 2 mg or 4 mg During Core Study) | Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) During Open- Label Extension Study | Week 8 | -3.08 Scores on a scale | Standard Deviation 8.273 |
| Perampanel (Perampanel 2 mg or 4 mg During Core Study) | Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) During Open- Label Extension Study | Week 20 | -2.72 Scores on a scale | Standard Deviation 8.521 |
| Perampanel (Perampanel 2 mg or 4 mg During Core Study) | Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) During Open- Label Extension Study | Week 32 | -2.84 Scores on a scale | Standard Deviation 7.677 |
| Perampanel (Perampanel 2 mg or 4 mg During Core Study) | Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) During Open- Label Extension Study | Week 44 | -2.07 Scores on a scale | Standard Deviation 9.209 |
| Perampanel (Perampanel 2 mg or 4 mg During Core Study) | Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) During Open- Label Extension Study | Week 56 | -0.84 Scores on a scale | Standard Deviation 9.428 |