Efficacy, Safety, and Tolerability of E2007 in Levodopa T... | NCT00368108

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
2 mg perampanel	Experimental	The Perampanel 2mg dosage was fixed for the entire double-blind study. Subjects taking perampanel 2mg were to take the dose orally once every day in the evening.	Drug: 2 mg perampanel
4 mg perampanel	Experimental	The Perampanel 4mg group first were subjected to a 4 week titration period, followed by a maintenance period for the remaining weeks. Subjects taking perampanel 4mg had a titration period of 4 weeks, starting at 2mg per day adding 1mg of perampel every two weeks up to 4mg. The dosages were to be taken orally once every day in the evening.	Drug: 4 mg perampanel
placebo	Placebo Comparator	The placebo dosage was a fixed dosage for the entire double-blind study. Subjects receiving the placebo were to take one dose orally once every day in the evening.	Drug: placebo comparator

Name	Type	Description	Arm Group Labels	Other Names
2 mg perampanel	Drug	2 mg perampanel	2 mg perampanel
4 mg perampanel

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean Change From Baseline in Total Daily OFF Time (Hours) to Week 20 (Including Last Observation Carried Forward [LOCF] Data)	Patients described themselves in home diaries as "OFF", "ON" without dyskinesias, "ON" with non troublesome dyskinesias, "ON" with troublesome dyskinesias, or Asleep, every 30 minutes during waking hours for 3 consecutive days prior to Baseline, Weeks 8, 10, 18, and 20. OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor.	Baseline and Week 20

Secondary Outcomes

Measure	Description	Time Frame
Mean Change From Baseline in Scale UPDRS Part II (ADL) Score in Total Daily OFF Time to Week 20 (Including LOCF Data)	Patients described themselves in home diaries every 30 minutes during waking hours for 3 consecutive days prior to Baseline, Weeks 8, 12, 16, and 20. Unified Parkinson's Disease (PD) Rating Scale (UPDRS) is a standardized assessment of the symptoms and signs of PD. 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. Range of possible total scores, 0 to 52. ON state is when medication is providing benefits to mobility, slowness, and stiffness. OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor.

Eligibility Module

Name	Affiliation	Role
David Squillacote, M.D.	Eisai Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35233	United States
North Alabama Neuroscience Research Associates

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	The placebo dosage was a fixed dosage for the entire double-blind study. Subjects receiving the placebo were to take one dose orally once every day in the evening.
FG001	Perampanel 2mg

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Placebo	The placebo dosage was a fixed dosage for the entire double-blind study. Subjects receiving the placebo were to take one dose orally once every day in the evening.
BG001	Perampanel 2mg	The Perampanel 2mg dosage was fixed for the entire double-blind study. Subjects taking perampanel 2mg were to take the dose orally once every day in the evening.
BG002	Perampanel 4mg	The Perampanel 4mg group first were subjected to a 4 week titration period, followed by a maintenance period for the remaining weeks. Subjects taking perampanel 4mg had a titration period of 4 weeks, starting at 2mg per day adding 1mg of perampanel every two weeks up to 4mg. The dosages were to be taken orally once every day in the evening.
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Customized

Number

Participants

Title

Denominators

Categories

<65 years

Title	Measurements
	BG000149 BG001144 BG002147 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00086 BG00187 BG002

Race/Ethnicity, Customized

Number

Participants

Title

Denominators

Categories

White

Title	Measurements
	BG000233 BG001239 BG002

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) to Week 20 (Including Last Observation Carried Forward [LOCF] Data)

Patients described themselves in home diaries as "OFF", "ON" without dyskinesias, "ON" with non troublesome dyskinesias, "ON" with troublesome dyskinesias, or Asleep, every 30 minutes during waking hours for 3 consecutive days prior to Baseline, Weeks 8, 10, 18, and 20. OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor.

The Intent-to-treat (ITT) Population for diary data consisted of all subjects who were randomized to either perampanel or placebo, had taken at least 1 dose, had a valid, nonmissing Baseline diary measurement and at least 1 valid, non-missing, postbaseline diary measurement at Last Observation Carried Forward (LOCF).

Posted

Least Squares Mean

95% Confidence Interval

Hours

Baseline and Week 20

ID	Title	Description
OG000	Placebo	The placebo dosage was a fixed dosage for the entire double-blind study. Subjects receiving the placebo were to take one dose orally once every day in the evening.
OG001	Perampanel 2mg	The Perampanel 2mg dosage was fixed for the entire double-blind study. Subjects taking perampanel 2mg were to take the dose orally once every day in the evening.
OG002	Perampanel 4mg	The Perampanel 4mg group first were subjected to a 4 week titration period, followed by a maintenance period for the remaining weeks. Subjects taking perampanel 4mg had a titration period of 4 weeks, starting at 2mg per day adding 1mg of perampanel every two weeks up to 4mg. The dosages were to be taken orally once every day in the evening.

Units	Counts
Participants	OG000208 OG001213 OG002201

Title

Denominators

Categories

Title	Measurements
	OG000-0.96(-1.42 to -0.51) OG001-0.93(-1.38 to -0.49) OG002-0.76(-1.20 to -0.31)

Secondary

Mean Change From Baseline in Scale UPDRS Part II (ADL) Score in Total Daily OFF Time to Week 20 (Including LOCF Data)

Patients described themselves in home diaries every 30 minutes during waking hours for 3 consecutive days prior to Baseline, Weeks 8, 12, 16, and 20. Unified Parkinson's Disease (PD) Rating Scale (UPDRS) is a standardized assessment of the symptoms and signs of PD. 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. Range of possible total scores, 0 to 52. ON state is when medication is providing benefits to mobility, slowness, and stiffness. OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor.

ITT Population

Posted

Least Squares Mean

95% Confidence Interval

Scores on a scale

Baseline and Week 20

ID	Title	Description
OG000	Placebo	The placebo dosage was a fixed dosage for the entire double-blind study. Subjects receiving the placebo were to take one dose orally once every day in the evening.
OG001	Perampanel 2mg	The Perampanel 2mg dosage was fixed for the entire double-blind study. Subjects taking perampanel 2mg were to take the dose orally once every day in the evening.
OG002

Secondary

Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) to Week 20 (Including LOCF Data)

Patients described themselves in home diaries every 30 minutes during waking hours for 3 days prior to Baseline, Weeks 8, 12, 16, and 20. UPDRS is a standardized assessment of the symptoms and signs of PD. 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. ON state is when medication is providing benefits to stiffness, slowness, and tremor.

ITT Population

Posted

Least Squares Mean

95% Confidence Interval

Scores on a Scale

Baseline and Week 20

ID	Title	Description
OG000	Placebo	The placebo dosage was a fixed dosage for the entire double-blind study. Subjects receiving the placebo were to take one dose orally once every day in the evening.
OG001	Perampanel 2mg	The Perampanel 2mg dosage was fixed for the entire double-blind study. Subjects taking perampanel 2mg were to take the dose orally once every day in the evening.
OG002	Perampanel 4mg	The Perampanel 4mg group first were subjected to a 4 week titration period, followed by a maintenance period for the remaining weeks. Subjects taking perampanel 4mg had a titration period of 4 weeks, starting at 2mg per day adding 1mg of perampanel every two weeks up to 4mg. The dosages were to be taken orally once every day in the evening.

Secondary

Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) to Week 20 (Including LOCF Data)

Patients described themselves in home diaries every 30 minutes during waking hours for 3 days prior to Baseline, Weeks 8, 12, 16, and 20. ON state is when medication is providing benefits to stiffness, slowness, and tremor.

ITT Population

Posted

Least Squares Mean

95% Confidence Interval

Hours

Baseline and Week 20

ID	Title	Description
OG000	Placebo	The placebo dosage was a fixed dosage for the entire double-blind study. Subjects receiving the placebo were to take one dose orally once every day in the evening.
OG001	Perampanel 2mg	The Perampanel 2mg dosage was fixed for the entire double-blind study. Subjects taking perampanel 2mg were to take the dose orally once every day in the evening.
OG002	Perampanel 4mg	The Perampanel 4mg group first were subjected to a 4 week titration period, followed by a maintenance period for the remaining weeks. Subjects taking perampanel 4mg had a titration period of 4 weeks, starting at 2mg per day adding 1mg of perampanel every two weeks up to 4mg. The dosages were to be taken orally once every day in the evening.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	The placebo dosage was a fixed dosage for the entire double-blind study. Subjects receiving the placebo were to take one dose orally once every day in the evening.	22	250	111	250
EG001	Perampanel 2mg	The Perampanel 2mg dosage was fixed for the entire double-blind study. Subjects taking perampanel 2mg were to take the dose orally once every day in the evening.	12	251	110	251
EG002	Perampanel 4mg	The Perampanel 4mg group first were subjected to a 4 week titration period, followed by a maintenance period for the remaining weeks. Subjects taking perampanel 4mg had a titration period of 4 weeks, starting at 2mg per day adding 1mg of perampanel every two weeks up to 4mg. The dosages were to be taken orally once every day in the evening.	18	250	144	250

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Syncope	Nervous system disorders	MedDRA V. 10.1	Systematic Assessment	EG0001 affected250 at risk EG0011 affected251 at risk EG0021 affected250 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA V. 10.1	Systematic Assessment	EG0000 affected250 at risk EG0010 affected251 at risk EG0021 affected250 at risk
Memory Impairment	Nervous system disorders	MedDRA V. 10.1	Systematic Assessment	EG0000 affected250 at risk EG0010 affected251 at risk EG0021 affected250 at risk
Myasthenia gravis	Nervous system disorders	MedDRA V. 10.1	Systematic Assessment	EG0000 affected250 at risk EG0010 affected251 at risk EG0021 affected250 at risk
ON and OFF phenomenon	Nervous system disorders	MedDRA V. 10.1	Systematic Assessment	EG0000 affected250 at risk EG0011 affected251 at risk EG0020 affected250 at risk
Quadriparesis	Nervous system disorders	MedDRA V. 10.1	Systematic Assessment	EG0000 affected250 at risk EG0010 affected251 at risk EG0021 affected250 at risk
Tremor	Nervous system disorders	MedDRA V. 10.1	Systematic Assessment	EG0000 affected250 at risk EG0011 affected251 at risk EG0020 affected250 at risk
Reversible ischaemic neurological deficit	Nervous system disorders	MedDRA V. 10.1	Systematic Assessment	EG0001 affected250 at risk EG0010 affected251 at risk EG0020 affected250 at risk
Tonic convulsion	Nervous system disorders	MedDRA V. 10.1	Systematic Assessment	EG0001 affected250 at risk EG0010 affected251 at risk EG0020 affected250 at risk
Atrial flutter	Cardiac disorders	MedDRA V. 10.1	Systematic Assessment	EG0000 affected250 at risk EG0010 affected251 at risk EG0021 affected250 at risk
Coronary artery disease	Cardiac disorders	MedDRA V. 10.1	Systematic Assessment	EG0000 affected250 at risk EG0011 affected251 at risk EG0020 affected250 at risk
Myocardial infarction	Cardiac disorders	MedDRA V. 10.1	Systematic Assessment	EG0002 affected250 at risk EG0011 affected251 at risk EG0020 affected250 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA V. 10.1	Systematic Assessment	EG0000 affected250 at risk EG0011 affected251 at risk EG0020 affected250 at risk
Angina Pectoris	Cardiac disorders	MedDRA V. 10.1	Systematic Assessment	EG0001 affected250 at risk EG0010 affected251 at risk EG0020 affected250 at risk
Cardio-Respiratory arrest	Cardiac disorders	MedDRA V. 10.1	Systematic Assessment	EG0001 affected250 at risk EG0010 affected251 at risk EG0020 affected250 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA V. 10.1	Systematic Assessment	EG0001 affected250 at risk EG0010 affected251 at risk EG0020 affected250 at risk
Constipation	Gastrointestinal disorders	MedDRA V. 10.1	Systematic Assessment	EG0000 affected250 at risk EG0010 affected251 at risk EG0021 affected250 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA V. 10.1	Systematic Assessment	EG0000 affected250 at risk EG0010 affected251 at risk EG0021 affected250 at risk
Oesophageal stenosis	Gastrointestinal disorders	MedDRA V. 10.1	Systematic Assessment	EG0000 affected250 at risk EG0010 affected251 at risk EG0021 affected250 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA V. 10.1	Systematic Assessment	EG0000 affected250 at risk EG0011 affected251 at risk EG0020 affected250 at risk
Crohn's disease	Gastrointestinal disorders	MedDRA V. 10.1	Systematic Assessment	EG0001 affected250 at risk EG0010 affected251 at risk EG0020 affected250 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA V. 10.1	Systematic Assessment	EG0001 affected250 at risk EG0010 affected251 at risk EG0020 affected250 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA V. 10.1	Systematic Assessment	EG0001 affected250 at risk EG0010 affected251 at risk EG0020 affected250 at risk
Non-cardiac chest pain	General disorders	MedDRA V. 10.1	Systematic Assessment	EG0000 affected250 at risk EG0011 affected251 at risk EG0021 affected250 at risk
Chest pain	General disorders	MedDRA V. 10.1	Systematic Assessment	EG0000 affected250 at risk EG0011 affected251 at risk EG0020 affected250 at risk
Pain	General disorders	MedDRA V. 10.1	Systematic Assessment	EG0000 affected250 at risk EG0011 affected251 at risk EG0020 affected250 at risk
Pneumonia	Infections and infestations	MedDRA V. 10.1	Systematic Assessment	EG0002 affected250 at risk EG0010 affected251 at risk EG0022 affected250 at risk
Cellulitis	Infections and infestations	MedDRA V. 10.1	Systematic Assessment	EG0000 affected250 at risk EG0010 affected251 at risk EG0021 affected250 at risk
Urinary tract infection	Infections and infestations	MedDRA V. 10.1	Systematic Assessment	EG0000 affected250 at risk EG0011 affected251 at risk EG0020 affected250 at risk
Fall	Injury, poisoning and procedural complications	MedDRA V. 10.1	Systematic Assessment	EG0001 affected250 at risk EG0011 affected251 at risk EG0021 affected250 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA V. 10.1	Systematic Assessment	EG0001 affected250 at risk EG0010 affected251 at risk EG0021 affected250 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA V. 10.1	Systematic Assessment	EG0002 affected250 at risk EG0010 affected251 at risk EG0021 affected250 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA V. 10.1	Systematic Assessment	EG0000 affected250 at risk EG0010 affected251 at risk EG0021 affected250 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA V. 10.1	Systematic Assessment	EG0001 affected250 at risk EG0010 affected251 at risk EG0020 affected250 at risk
Stress fracture	Injury, poisoning and procedural complications	MedDRA V. 10.1	Systematic Assessment	EG0001 affected250 at risk EG0010 affected251 at risk EG0020 affected250 at risk
Confusional state	Psychiatric disorders	MedDRA V. 10.1	Systematic Assessment	EG0000 affected250 at risk EG0010 affected251 at risk EG0021 affected250 at risk
Hallucination	Psychiatric disorders	MedDRA V. 10.1	Systematic Assessment	EG0000 affected250 at risk EG0011 affected251 at risk EG0020 affected250 at risk
Suicide attempt	Psychiatric disorders	MedDRA V. 10.1	Systematic Assessment	EG0000 affected250 at risk EG0010 affected251 at risk EG0021 affected250 at risk
Delirium	Psychiatric disorders	MedDRA V. 10.1	Systematic Assessment	EG0001 affected250 at risk EG0010 affected251 at risk EG0020 affected250 at risk
Hallucination, visual	Psychiatric disorders	MedDRA V. 10.1	Systematic Assessment	EG0001 affected250 at risk EG0010 affected251 at risk EG0020 affected250 at risk
Major depression	Psychiatric disorders	MedDRA V. 10.1	Systematic Assessment	EG0001 affected250 at risk EG0010 affected251 at risk EG0020 affected250 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA V. 10.1	Systematic Assessment	EG0000 affected250 at risk EG0010 affected251 at risk EG0021 affected250 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA V. 10.1	Systematic Assessment	EG0001 affected250 at risk EG0011 affected251 at risk EG0020 affected250 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA V. 10.1	Systematic Assessment	EG0001 affected250 at risk EG0010 affected251 at risk EG0020 affected250 at risk
Melanoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA V. 10.1	Systematic Assessment	EG0000 affected250 at risk EG0011 affected251 at risk EG0020 affected250 at risk
Bile duct cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA V. 10.1	Systematic Assessment	EG0001 affected250 at risk EG0010 affected251 at risk EG0020 affected250 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA V. 10.1	Systematic Assessment	EG0001 affected250 at risk EG0010 affected251 at risk EG0020 affected250 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA V. 10.1	Systematic Assessment	EG0000 affected250 at risk EG0010 affected251 at risk EG0021 affected250 at risk
Micturition urgency	Renal and urinary disorders	MedDRA V. 10.1	Systematic Assessment	EG0001 affected250 at risk EG0010 affected251 at risk EG0020 affected250 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA V. 10.1	Systematic Assessment	EG0000 affected250 at risk EG0010 affected251 at risk EG0021 affected250 at risk
Hospitalization	Surgical and medical procedures	MedDRA V. 10.1	Systematic Assessment	EG0000 affected250 at risk EG0011 affected251 at risk EG0020 affected250 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA V. 10.1	Systematic Assessment	EG0001 affected250 at risk EG0010 affected251 at risk EG0020 affected250 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA V. 10.1	Systematic Assessment	EG00016 affected250 at risk EG00111 affected251 at risk EG00212 affected250 at risk
Urinary Tract Infection	Infections and infestations	MedDRA V. 10.1	Systematic Assessment	EG00010 affected250 at risk EG00111 affected251 at risk EG00213 affected250 at risk
Fall	Injury, poisoning and procedural complications	MedDRA V. 10.1	Systematic Assessment	EG00023 affected250 at risk EG00123 affected251 at risk EG00219 affected250 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA V. 10.1	Systematic Assessment	EG0007 affected250 at risk EG00116 affected251 at risk EG00212 affected250 at risk
Balance Disorder	Nervous system disorders	MedDRA V. 10.1	Systematic Assessment	EG0003 affected250 at risk EG0016 affected251 at risk EG00217 affected250 at risk
Dizziness	Nervous system disorders	MedDRA V. 10.1	Systematic Assessment	EG00014 affected250 at risk EG00115 affected251 at risk EG00229 affected250 at risk
Dyskinesia	Nervous system disorders	MedDRA V. 10.1	Systematic Assessment	EG00039 affected250 at risk EG00121 affected251 at risk EG00243 affected250 at risk
Headache	Nervous system disorders	MedDRA V. 10.1	Systematic Assessment	EG00018 affected250 at risk EG00110 affected251 at risk EG00212 affected250 at risk
ON and OFF phenomenon	Nervous system disorders	MedDRA V. 10.1	Systematic Assessment	EG00024 affected250 at risk EG00118 affected251 at risk EG00221 affected250 at risk
Somnolence	Nervous system disorders	MedDRA V. 10.1	Systematic Assessment	EG00013 affected250 at risk EG00132 affected251 at risk EG00240 affected250 at risk
Insomnia	Psychiatric disorders	MedDRA V. 10.1	Systematic Assessment	EG00015 affected250 at risk EG00114 affected251 at risk EG00215 affected250 at risk

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D009069	Movement Disorders
D000080874	Synucleinopathies
D019636	Neurodegenerative Diseases