Survey on PD Patients With Depressive Symptoms | NCT00614575

Status Module

Sponsor/Collaborators Module

Description Module

Design Module

Interventional Study Design

Biospecimen

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Arms/Interventions Module

Label	Type	Description	Intervention Names
BI-Sifrol® Tablets (Pramipexole)		BI-Sifrol® Tablets, pramipexole dose: 0.125 mg, 0.5 mg, No reference therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Adverse Events, Adverse Drug Reactions, and Serious Adverse Events	The aim of this Post Marketing Surveillance (PMS) was to obtain safety data with treatment of pramipexole in Parkinson's disease patients with depressive symptoms. The percentage of participants with adverse events, adverse drug reactions, and serious adverse events are presented.	for 12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Clinical Global Impression of Improvement	Investigators evaluation of the Parkinson's disease (PD) symptoms on the Clinical Global Impression (CGI) with 5 categories (very much improved, much improved, minimally improved, no effect, and unassessable).	for 12 weeks after initiation of the treatment
Mean Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Boehringer Ingelheim Investigational Site		Akashi			Japan
Boehringer Ingelheim Investigational Site 1

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	BI-Sifrol Tablets	According to the dosage and administration described in the package insert of the drug in Japan, the drug was administered orally to PD patients with depressive symptoms under condition of routine medical practice. The description is as follows; Usually in adults, the starting dosage of pramipexole hydrochloride hydrate is 0.25 mg/day, followed by 0.5 mg/day during Week 2 of treatment, and the dosage is then increased by 0.5 mg/day each week under close observation to determine the maintenance dose (standard daily dose, 1.5-4.5 mg). When the daily dose of pramipexole hydrochloride hydrate is less than 1.5 mg, the daily dose will be divided into two doses to be taken after breakfast and after dinner. When the daily dose is 1.5 mg or higher, the daily dose will be divided into three doses to be taken after every meal. The dosage may be adjusted according to age and symptoms of the patient, but the daily dose should not exceed 4.5 mg.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Derived Section

Miscellaneous Info Module

Submission Tracking

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Condition Browse Module

Intervention Browse Module

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Arm/Group Information

ID	Title	Description
BG000	BI-Sifrol Tablets	According to the dosage and administration described in the package insert of the drug in Japan, the drug was administered orally to PD patients with depressive symptoms under condition of routine medical practice. The description is as follows; Usually in adults, the starting dosage of pramipexole hydrochloride hydrate is 0.25 mg/day, followed by 0.5 mg/day during Week 2 of treatment, and the dosage is then increased by 0.5 mg/day each week under close observation to determine the maintenance dose (standard daily dose, 1.5-4.5 mg). When the daily dose of pramipexole hydrochloride hydrate is less than 1.5 mg, the daily dose will be divided into two doses to be taken after breakfast and after dinner. When the daily dose is 1.5 mg or higher, the daily dose will be divided into three doses to be taken after every meal. The dosage may be adjusted according to age and symptoms of the patient, but the daily dose should not exceed 4.5 mg.

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

The number of patients enrolled was 1089. The number of case reports collected from the patients enrolled in this survey was 1071. Moreover the number of patients analyzed as safety analysis was 1044, because 27 patients were excluded due to protocol violations.

Mean

Standard Deviation

years

Title

Denominators

Categories

Very much improved

Title	Measurements
	OG00076

Much improved

Title	Measurements
	OG000399

Minimally improved

Secondary

Mean Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score

Part III of the UPDRS contains the clinician-scored motor evaluation, and includes 14 individual items each scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56. A negative change in the Part III total score indicates improvement.

Efficacy analysis set

Posted

Mean

Standard Deviation

Unit on a scale

Baseline and after 12 weeks (or at the time of discontinuation)

ID	Title	Description
OG000	BI-Sifrol Tablets	According to the dosage and administration described in the package insert of the drug in Japan, the drug was administered orally to PD patients with depressive symptoms under condition of routine medical practice. The description is as follows; Usually in adults, the starting dosage of pramipexole hydrochloride hydrate is 0.25 mg/day, followed by 0.5 mg/day during Week 2 of treatment, and the dosage is then increased by 0.5 mg/day each week under close observation to determine the maintenance dose (standard daily dose, 1.5-4.5 mg). When the daily dose of pramipexole hydrochloride hydrate is less than 1.5 mg, the daily dose will be divided into two doses to be taken after breakfast and after dinner. When the daily dose is 1.5 mg or higher, the daily dose will be divided into three doses to be taken after every meal. The dosage may be adjusted according to age and symptoms of the patient, but the daily dose should not exceed 4.5 mg.

Secondary

Mean Change From Baseline in Beck's Depression Inventory (BDI) Total Score

The degree of severity in depressive state are scored between 0-63 in BDI. A decrease in the score means improvement.

Efficacy analysis set

Posted

Mean

Standard Deviation

Unit on a scale

Baseline and after 12 weeks (or at the time of discontinuation)

ID	Title	Description
OG000	BI-Sifrol Tablets	According to the dosage and administration described in the package insert of the drug in Japan, the drug was administered orally to PD patients with depressive symptoms under condition of routine medical practice. The description is as follows; Usually in adults, the starting dosage of pramipexole hydrochloride hydrate is 0.25 mg/day, followed by 0.5 mg/day during Week 2 of treatment, and the dosage is then increased by 0.5 mg/day each week under close observation to determine the maintenance dose (standard daily dose, 1.5-4.5 mg). When the daily dose of pramipexole hydrochloride hydrate is less than 1.5 mg, the daily dose will be divided into two doses to be taken after breakfast and after dinner. When the daily dose is 1.5 mg or higher, the daily dose will be divided into three doses to be taken after every meal. The dosage may be adjusted according to age and symptoms of the patient, but the daily dose should not exceed 4.5 mg.

Units	Counts
Participants

Secondary

Mean Change From Baseline in UPDRS (Unified Parkinson's Disease Rating Scale) Part I Item 3 Score

Unified Parkinson's Disease Rating Scale Part I Item 3 assesses the participant for symptoms of depression. Item 3 scores range from 0 (None) to 4 (Sustained depression with suicidal thoughts or intent). A higher score indicates more severe depression symptoms. A negative change in the item 3 score indicates improvement.

Efficacy analysis set

Posted

Mean

Standard Deviation

Unit on a scale

Baseline and after 12 weeks (or at the time of discontinuation)

ID	Title	Description
OG000	BI-Sifrol Tablets	According to the dosage and administration described in the package insert of the drug in Japan, the drug was administered orally to PD patients with depressive symptoms under condition of routine medical practice. The description is as follows; Usually in adults, the starting dosage of pramipexole hydrochloride hydrate is 0.25 mg/day, followed by 0.5 mg/day during Week 2 of treatment, and the dosage is then increased by 0.5 mg/day each week under close observation to determine the maintenance dose (standard daily dose, 1.5-4.5 mg). When the daily dose of pramipexole hydrochloride hydrate is less than 1.5 mg, the daily dose will be divided into two doses to be taken after breakfast and after dinner. When the daily dose is 1.5 mg or higher, the daily dose will be divided into three doses to be taken after every meal. The dosage may be adjusted according to age and symptoms of the patient, but the daily dose should not exceed 4.5 mg.

Secondary

Mean Change From Baseline in Modified Hoehn & Yahr Rating Scale

This scale is an investigator-completed assessment of the degree of complications arising from Parkinson's disease. The scale ranges from 0 (No signs) to 5 (Bedridden). A negative change in the Yahr rating scale indicates improvement.

Efficacy Analysis Set

Posted

Mean

Standard Deviation

units on a scale

After 12 weeks or at the time of discontinuation

ID	Title	Description
OG000	BI-Sifrol Tablets	According to the dosage and administration described in the package insert of the drug in Japan, the drug was administered orally to PD patients with depressive symptoms under condition of routine medical practice. The description is as follows; Usually in adults, the starting dosage of pramipexole hydrochloride hydrate is 0.25 mg/day, followed by 0.5 mg/day during Week 2 of treatment, and the dosage is then increased by 0.5 mg/day each week under close observation to determine the maintenance dose (standard daily dose, 1.5-4.5 mg). When the daily dose of pramipexole hydrochloride hydrate is less than 1.5 mg, the daily dose will be divided into two doses to be taken after breakfast and after dinner. When the daily dose is 1.5 mg or higher, the daily dose will be divided into three doses to be taken after every meal. The dosage may be adjusted according to age and symptoms of the patient, but the daily dose should not exceed 4.5 mg.

Units	Counts

Primary

Percentage of Participants With Adverse Events, Adverse Drug Reactions, and Serious Adverse Events

The aim of this Post Marketing Surveillance (PMS) was to obtain safety data with treatment of pramipexole in Parkinson's disease patients with depressive symptoms. The percentage of participants with adverse events, adverse drug reactions, and serious adverse events are presented.

Safety Analysis Set

Posted

Number

percentage of participants

for 12 weeks

ID	Title	Description
OG000	BI-Sifrol Tablets	According to the dosage and administration described in the package insert of the drug in Japan, the drug was administered orally to PD patients with depressive symptoms under condition of routine medical practice. The description is as follows; Usually in adults, the starting dosage of pramipexole hydrochloride hydrate is 0.25 mg/day, followed by 0.5 mg/day during Week 2 of treatment, and the dosage is then increased by 0.5 mg/day each week under close observation to determine the maintenance dose (standard daily dose, 1.5-4.5 mg). When the daily dose of pramipexole hydrochloride hydrate is less than 1.5 mg, the daily dose will be divided into two doses to be taken after breakfast and after dinner. When the daily dose is 1.5 mg or higher, the daily dose will be divided into three doses to be taken after every meal. The dosage may be adjusted according to age and symptoms of the patient, but the daily dose should not exceed 4.5 mg.

Units

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	BI-Sifrol Tablets	According to the dosage and administration described in the package insert of the drug in Japan, the drug was administered orally to PD patients with depressive symptoms under condition of routine medical practice. The description is as follows; Usually in adults, the starting dosage of pramipexole hydrochloride hydrate is 0.25 mg/day, followed by 0.5 mg/day during Week 2 of treatment, and the dosage is then increased by 0.5 mg/day each week under close observation to determine the maintenance dose (standard daily dose, 1.5-4.5 mg). When the daily dose of pramipexole hydrochloride hydrate is less than 1.5 mg, the daily dose will be divided into two doses to be taken after breakfast and after dinner. When the daily dose is 1.5 mg or higher, the daily dose will be divided into three doses to be taken after every meal. The dosage may be adjusted according to age and symptoms of the patient, but the daily dose should not exceed 4.5 mg.			26	1,044	71	1,044

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Bronchitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected1,044 at risk
Pneumonia	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected1,044 at risk
Nasal sinus cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected1,044 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected1,044 at risk
Large intestine carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected1,044 at risk
Gastrointestinal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected1,044 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected1,044 at risk
Confusional state	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected1,044 at risk
Delirium	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected1,044 at risk
Delusion	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0003 events3 affected1,044 at risk
Hallucination	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0004 events4 affected1,044 at risk
Somatoform disorder	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected1,044 at risk
Cerebral infarction	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected1,044 at risk
Dizziness	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected1,044 at risk
Neuroleptic malignant syndrome	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected1,044 at risk
Dementia with Lewy bodies	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected1,044 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected1,044 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0004 events4 affected1,044 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected1,044 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected1,044 at risk
Ileus	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected1,044 at risk
Vomiting	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected1,044 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected1,044 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected1,044 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected1,044 at risk
Death	General disorders	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected1,044 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0003 events3 affected1,044 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected1,044 at risk
Fracture	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected1,044 at risk

Ancestor Terms

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