Trial Outcomes & Findings for Survey on PD Patients With Depressive Symptoms (NCT NCT00614575)
NCT ID: NCT00614575
Last Updated: 2014-08-06
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
1089 participants
Primary outcome timeframe
for 12 weeks
Results posted on
2014-08-06
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
1089
|
|
Overall Study
COMPLETED
|
861
|
|
Overall Study
NOT COMPLETED
|
228
|
Reasons for withdrawal
| Measure |
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.
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|---|---|
|
Overall Study
Adverse Event
|
106
|
|
Overall Study
Lost to Follow-up
|
55
|
|
Overall Study
Lack of Efficacy
|
14
|
|
Overall Study
Withdrawal by Subject
|
6
|
|
Overall Study
Death
|
3
|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
No data were collected.
|
18
|
|
Overall Study
Irregularly enrolled patients
|
23
|
|
Overall Study
No treatment
|
1
|
Baseline Characteristics
Survey on PD Patients With Depressive Symptoms
Baseline characteristics by cohort
| Measure |
BI-Sifrol Tablets
n=1044 Participants
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.
|
|---|---|
|
Age, Continuous
|
70.5 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
668 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
376 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: for 12 weeksPopulation: Safety Analysis Set
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.
Outcome measures
| Measure |
BI-Sifrol Tablets
n=1044 Participants
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.
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|---|---|
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Percentage of Participants With Adverse Events, Adverse Drug Reactions, and Serious Adverse Events
Proportion of Adverse Events
|
21.7 percentage of participants
|
|
Percentage of Participants With Adverse Events, Adverse Drug Reactions, and Serious Adverse Events
Proportion of Adverse Drug Reactions
|
19.2 percentage of participants
|
|
Percentage of Participants With Adverse Events, Adverse Drug Reactions, and Serious Adverse Events
Proportion of Serious Adverse Events
|
2.5 percentage of participants
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SECONDARY outcome
Timeframe: for 12 weeks after initiation of the treatmentPopulation: Efficacy analysis set
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).
Outcome measures
| Measure |
BI-Sifrol Tablets
n=949 Participants
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.
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|---|---|
|
Clinical Global Impression of Improvement
Very much improved
|
76 participants
|
|
Clinical Global Impression of Improvement
Much improved
|
399 participants
|
|
Clinical Global Impression of Improvement
Minimally improved
|
348 participants
|
|
Clinical Global Impression of Improvement
No effect
|
102 participants
|
|
Clinical Global Impression of Improvement
Unassessable
|
24 participants
|
SECONDARY outcome
Timeframe: Baseline and after 12 weeks (or at the time of discontinuation)Population: Efficacy analysis set
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.
Outcome measures
| Measure |
BI-Sifrol Tablets
n=933 Participants
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.
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|---|---|
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Mean Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score
|
-7.2 Unit on a scale
Standard Deviation 9.0
|
SECONDARY outcome
Timeframe: Baseline and after 12 weeks (or at the time of discontinuation)Population: Efficacy analysis set
The degree of severity in depressive state are scored between 0-63 in BDI. A decrease in the score means improvement.
Outcome measures
| Measure |
BI-Sifrol Tablets
n=887 Participants
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.
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|---|---|
|
Mean Change From Baseline in Beck's Depression Inventory (BDI) Total Score
|
-4.8 Unit on a scale
Standard Deviation 7.8
|
SECONDARY outcome
Timeframe: Baseline and after 12 weeks (or at the time of discontinuation)Population: Efficacy analysis set
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.
Outcome measures
| Measure |
BI-Sifrol Tablets
n=945 Participants
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.
|
|---|---|
|
Mean Change From Baseline in UPDRS (Unified Parkinson's Disease Rating Scale) Part I Item 3 Score
|
-0.7 Unit on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: After 12 weeks or at the time of discontinuationPopulation: Efficacy Analysis Set
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.
Outcome measures
| Measure |
BI-Sifrol Tablets
n=945 Participants
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.
|
|---|---|
|
Mean Change From Baseline in Modified Hoehn & Yahr Rating Scale
|
-0.3 units on a scale
Standard Deviation 0.6
|
Adverse Events
BI-Sifrol Tablets
Serious events: 26 serious events
Other events: 71 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BI-Sifrol Tablets
n=1044 participants at risk
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.
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|---|---|
|
Infections and infestations
Bronchitis
|
0.10%
1/1044 • Number of events 1 • 12 weeks
Interview at each visit. 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.
|
|
Infections and infestations
Pneumonia
|
0.19%
2/1044 • Number of events 2 • 12 weeks
Interview at each visit. 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nasal sinus cancer
|
0.10%
1/1044 • Number of events 1 • 12 weeks
Interview at each visit. 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.10%
1/1044 • Number of events 1 • 12 weeks
Interview at each visit. 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large intestine carcinoma
|
0.10%
1/1044 • Number of events 1 • 12 weeks
Interview at each visit. 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal neoplasm
|
0.10%
1/1044 • Number of events 1 • 12 weeks
Interview at each visit. 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.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.10%
1/1044 • Number of events 1 • 12 weeks
Interview at each visit. 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.
|
|
Psychiatric disorders
Confusional state
|
0.10%
1/1044 • Number of events 1 • 12 weeks
Interview at each visit. 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.
|
|
Psychiatric disorders
Delirium
|
0.19%
2/1044 • Number of events 2 • 12 weeks
Interview at each visit. 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.
|
|
Psychiatric disorders
Delusion
|
0.29%
3/1044 • Number of events 3 • 12 weeks
Interview at each visit. 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.
|
|
Psychiatric disorders
Hallucination
|
0.38%
4/1044 • Number of events 4 • 12 weeks
Interview at each visit. 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.
|
|
Psychiatric disorders
Somatoform disorder
|
0.10%
1/1044 • Number of events 1 • 12 weeks
Interview at each visit. 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.
|
|
Nervous system disorders
Cerebral infarction
|
0.10%
1/1044 • Number of events 1 • 12 weeks
Interview at each visit. 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.
|
|
Nervous system disorders
Dizziness
|
0.10%
1/1044 • Number of events 1 • 12 weeks
Interview at each visit. 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.
|
|
Nervous system disorders
Neuroleptic malignant syndrome
|
0.10%
1/1044 • Number of events 1 • 12 weeks
Interview at each visit. 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.
|
|
Nervous system disorders
Dementia with Lewy bodies
|
0.10%
1/1044 • Number of events 1 • 12 weeks
Interview at each visit. 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.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.10%
1/1044 • Number of events 1 • 12 weeks
Interview at each visit. 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.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.38%
4/1044 • Number of events 4 • 12 weeks
Interview at each visit. 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.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.10%
1/1044 • Number of events 1 • 12 weeks
Interview at each visit. 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.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.10%
1/1044 • Number of events 1 • 12 weeks
Interview at each visit. 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.
|
|
Gastrointestinal disorders
Ileus
|
0.10%
1/1044 • Number of events 1 • 12 weeks
Interview at each visit. 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.
|
|
Gastrointestinal disorders
Vomiting
|
0.10%
1/1044 • Number of events 1 • 12 weeks
Interview at each visit. 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.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.10%
1/1044 • Number of events 1 • 12 weeks
Interview at each visit. 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.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.10%
1/1044 • Number of events 1 • 12 weeks
Interview at each visit. 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.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.10%
1/1044 • Number of events 1 • 12 weeks
Interview at each visit. 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.
|
|
General disorders
Death
|
0.19%
2/1044 • Number of events 2 • 12 weeks
Interview at each visit. 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.
|
|
Injury, poisoning and procedural complications
Fall
|
0.29%
3/1044 • Number of events 3 • 12 weeks
Interview at each visit. 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.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.19%
2/1044 • Number of events 2 • 12 weeks
Interview at each visit. 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.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.10%
1/1044 • Number of events 1 • 12 weeks
Interview at each visit. 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.
|
Other adverse events
| Measure |
BI-Sifrol Tablets
n=1044 participants at risk
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.
|
|---|---|
|
Nervous system disorders
Somnolence
|
6.8%
71/1044 • Number of events 71 • 12 weeks
Interview at each visit. 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.
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
- Publication restrictions are in place
Restriction type: OTHER