A Study of E2007 In Patients With Parkinson's Disease | NCT00427011

NCT00427011

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Label	Type	Description	Intervention Names
1	Experimental		Drug: E2007

Name	Type	Description	Arm Group Labels	Other Names
E2007	Drug	E2007 2mg tablets. Dose (2mg, 4mg, 6mg or 8mg), is taken orally at nighttime.	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean Change From Baseline by Visit in Absolute 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 12, Week 20, Week 32, Week 44, Week 56

Secondary Outcomes

Measure	Description	Time Frame
Mean Change From Baseline by Visit in Absolute ON Time (Without Dyskinesias or With Nontroublesome 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 12, Week 20, Week 32, Week 44, Week 56

Eligibility Module

Eligibility Criteria

INCLUSION CRITERIA

1. Male or female patients with idiopathic Parkinson's disease who have fulfilled the entry criteria for E2007-A001-214 and have completed that study up to and including the end of treatment (Day 70) visit and the Follow-up Visit at Day 91.

EXCLUSION CRITERIA

Pregnant or lactating women.
Women of child bearing potential unless infertile (including surgically sterile) or practicing effective contraception (e.g., intrauterine device or barrier method plus hormonal method). These patients must have a negative serum beta human chorionic gonadotropin (B-HCG) test at the initial visit (Visit 1) and urine pregnancy tests throughout the study. 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 nonchildbearing potential as determined by the investigator.
Patients who withdrew from Study 214 prior to the final efficacy visit for any reason, including lack of efficacy.
Patients with serious adverse events in Study 214 that are either ongoing or that are possibly or probably related to the study drug.
Patients with ongoing adverse events from Study 214 thought to be related to E2007.
Patients with a past (within the past 5 years) or present history of drug or alcohol abuse as per the criteria in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM IV).
Patients with a past (within 1 year) or present history of psychotic symptoms requiring antipsychotic treatment.
Patients with a past (within 1 year) or present history of suicidal ideation or suicide attempts.
Patients with active hepatic disease, significantly reduced hepatic function or significantly elevated liver enzymes (abnormal bilirubin or serum transaminase levels of more than 1.5 times the upper limit of the normal range).
Patients with clinically significant ECG abnormality, including prolonged QTc (defined as QTc >= 450 msec using Fridericia's correction).
Patients with clinically significant cardiovascular, metabolic, respiratory, renal, endocrinological, gastrointestinal diseases, psychiatric disorders, and bacterial or viral infections within the previous 30 days.
Patients who are currently taking medications known to induce the enzyme cytochrome P450 3A4.
Patients with current or prior treatment (within 4 weeks before entry visit) with tolcapone, methyldopa, budipine, reserpine, seroquel, or intermittent use of either liquid forms of levodopa or subcutaneous apomorphine.
Patients with previous stereotactic surgery (e.g., pallidotomy) for Parkinson's disease or with planned stereotactic surgery during the study period.
Patients receiving or with planned (next 6 months) deep brain stimulation.
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.
Patients with any condition that would make the patient, in the opinion of the investigator, unsuitable for the study.
Patients who have received an investigational product (other than E2007) within 4 weeks before screening.
Patients with clinically significant cognitive impairment (mini-mental state examination [MMSE] <24 or fulfilling DSM IV criteria for dementia due to Parkinson's disease).
Patients with any condition that could, in the opinion of the investigator, place the patient at increased risk or is likely to prevent completion of the study.

Name	Affiliation	Role
David Squillacote, MD	Eisai Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pivotal Research Centers		Peoria	Arizona	85381	United States
Clinical Trials Incorporated

ID	Title	Description
FG000	Perampanel	Subjects entered this open-label extension study from the double-blind core study E2007-A001-214 (NCT00165789), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Perampanel	Subjects entered this open-label extension study from the double-blind core study (E2007 A001 214), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age Continuous	Safety population.

Outcome Measures Module

Outcome Measures

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 by Visit in Absolute 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.

Safety population.

Posted

Mean

Standard Deviation

hours

Baseline, Week 12, Week 20, Week 32, Week 44, Week 56

ID	Title	Description
OG000	Perampanel (Placebo During Core Study)	Subjects entered this open-label extension study from the double-blind core study (E2007 A001 214), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Perampanel	Subjects entered this open-label extension study from the double-blind core study (E2007 A001 214), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases