Trial Outcomes & Findings for Special Survey on Parkinson's Disease (PD) Patients Without Concomitant Use of L-Dopa (NCT NCT00613301)
NCT ID: NCT00613301
Last Updated: 2014-06-06
Results Overview
The aim of this Post Marketing Surveillance (PMS) was to obtain safety data in Parkinson's disease (PD) patients without concomitant use of levodopa for 3 years.
COMPLETED
416 participants
during 36 months
2014-06-06
Participant Flow
Participant milestones
| Measure |
Pramipexole
BI-Sifrol® Tablets dose: 0.125 mg, 0.5 mg mode of administration: oral
|
|---|---|
|
Overall Study
STARTED
|
416
|
|
Overall Study
COMPLETED
|
188
|
|
Overall Study
NOT COMPLETED
|
228
|
Reasons for withdrawal
| Measure |
Pramipexole
BI-Sifrol® Tablets dose: 0.125 mg, 0.5 mg mode of administration: oral
|
|---|---|
|
Overall Study
Adverse Event
|
49
|
|
Overall Study
Lost to Follow-up
|
88
|
|
Overall Study
Withdrawal by Subject
|
5
|
|
Overall Study
Death
|
6
|
|
Overall Study
Lack of Efficacy
|
13
|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
No data was collected
|
53
|
|
Overall Study
Irregularly enrolled patients
|
12
|
Baseline Characteristics
Special Survey on Parkinson's Disease (PD) Patients Without Concomitant Use of L-Dopa
Baseline characteristics by cohort
| Measure |
Pramipexole
n=346 Participants
The number of patients enrolled was 416. The number of case report form which were collected was 364. Moreover the number of patients analyzed as safety analysis was 346 because 18 patients were excluded due to protocol violations.
|
|---|---|
|
Age, Continuous
|
66.2 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
187 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
159 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: during 36 monthsPopulation: 364 patients had available case report forms. Patients excluded: 5 patients with no visit since the first prescription, 12 irregularly enrolled patients, 9 excluded from analysis according to regulatory requirement, and 1 patient with no safety data available. As a result, there were 346 patients in the safety analysis set.
The aim of this Post Marketing Surveillance (PMS) was to obtain safety data in Parkinson's disease (PD) patients without concomitant use of levodopa for 3 years.
Outcome measures
| Measure |
Pramipexole
n=346 Participants
Substance (INN): Pramipexole Trade name: BI-Sifrol® Pharmaceutical form: Tablet Source: Marketed products (There was no investigational products in this PMS) Unit strength: 0.125 mg and 0.5 mg Daily dose: Approved dose range (From 0.25 mg/day to 4.5 mg/day) Duration of use: 3 years Route of administration: Orally
|
|---|---|
|
Proportion of Adverse Events, Adverse Drug Reactions, Serious Adverse Events
Proportion of Adverse Events
|
51.7 Proportion (percentage of participants)
|
|
Proportion of Adverse Events, Adverse Drug Reactions, Serious Adverse Events
Proportion of Adverse Drug Reactions
|
41.3 Proportion (percentage of participants)
|
|
Proportion of Adverse Events, Adverse Drug Reactions, Serious Adverse Events
Proportion of Serious Adverse Events
|
8.4 Proportion (percentage of participants)
|
SECONDARY outcome
Timeframe: after 36 months treatmentPopulation: There were 346 patients in the safety analysis set. Patients excluded from this population: 5 because of administration to patients who didn't suffer from PD and 2 with no efficacy data available. As a result, 339 patients were evaluated for efficacy.
Investigators evaluation of the PD symptoms on a rating scale of 5 categories (very much improved, much improved, minimally improved, no effect, and unassessable).
Outcome measures
| Measure |
Pramipexole
n=339 Participants
Substance (INN): Pramipexole Trade name: BI-Sifrol® Pharmaceutical form: Tablet Source: Marketed products (There was no investigational products in this PMS) Unit strength: 0.125 mg and 0.5 mg Daily dose: Approved dose range (From 0.25 mg/day to 4.5 mg/day) Duration of use: 3 years Route of administration: Orally
|
|---|---|
|
Clinical Global Impression of Improvement
Very much improved
|
19 Participants
|
|
Clinical Global Impression of Improvement
Much improved
|
137 Participants
|
|
Clinical Global Impression of Improvement
Minimally improved
|
97 Participants
|
|
Clinical Global Impression of Improvement
No effect
|
15 Participants
|
|
Clinical Global Impression of Improvement
Unassessable
|
71 Participants
|
SECONDARY outcome
Timeframe: Baseline and at 36 months (or at the time of discontinuation)Population: The number of patients (291) means a population who have the assessment of UPDRS Part III total score at baseline and at least one post-visit after administration of pramipexole.
Motor examination is assessed by 27 questionnaire items in UPDRS Part III section. Each item is scored from 0 (best) to 4 (worst), and the total score of UPDRS Part III is from 0 (best) to 108 (worst). A decrease in the score means improvement.
Outcome measures
| Measure |
Pramipexole
n=291 Participants
Substance (INN): Pramipexole Trade name: BI-Sifrol® Pharmaceutical form: Tablet Source: Marketed products (There was no investigational products in this PMS) Unit strength: 0.125 mg and 0.5 mg Daily dose: Approved dose range (From 0.25 mg/day to 4.5 mg/day) Duration of use: 3 years Route of administration: Orally
|
|---|---|
|
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score
|
-5.2 Unit on a scale
Standard Deviation 11.2
|
SECONDARY outcome
Timeframe: Baseline and at 36 months (or at the time of discontinuation)Population: The number of patients (295) means a population who have the assessment of Modified Hoehn \& Yahr rating scale at baseline and at least one post-visit after administration of pramipexole.
A severity of PD symptom are assessed by Modified Hoehn \& Yahr rating scale. This scale consist of 10 levels including additional evaluation levels defined in Japan. Ten levels are described by 0 (best), 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5 (worst).
Outcome measures
| Measure |
Pramipexole
n=295 Participants
Substance (INN): Pramipexole Trade name: BI-Sifrol® Pharmaceutical form: Tablet Source: Marketed products (There was no investigational products in this PMS) Unit strength: 0.125 mg and 0.5 mg Daily dose: Approved dose range (From 0.25 mg/day to 4.5 mg/day) Duration of use: 3 years Route of administration: Orally
|
|---|---|
|
Change From Baseline in Modified Hoehn & Yahr Rating Scale
|
-0.1 Unit on a scale
Standard Deviation 0.7
|
Adverse Events
Pramipexole
Serious adverse events
| Measure |
Pramipexole
n=346 participants at risk
The drug was administered orally to patients according to the package insert in Japan. The drug form is only tablet. The initial dose was 0.125 mg twice a day, and was escalated in case of lack of efficacy. The maintenance dose was between 1.5 mg/day and 4.5 mg/day (0.5 mg - 1.5 mg three times a day).
|
|---|---|
|
Infections and infestations
Pneumonia
|
0.29%
1/346 • 36 months
|
|
Infections and infestations
Septic shock
|
0.29%
1/346 • 36 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.29%
1/346 • 36 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.29%
1/346 • 36 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.58%
2/346 • 36 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large intestine carcinoma
|
0.29%
1/346 • 36 months
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.29%
1/346 • 36 months
|
|
Metabolism and nutrition disorders
Cachexia
|
0.29%
1/346 • 36 months
|
|
Psychiatric disorders
Agitation
|
0.29%
1/346 • 36 months
|
|
Psychiatric disorders
Delusion
|
0.29%
1/346 • 36 months
|
|
Psychiatric disorders
Hallucination
|
0.29%
1/346 • 36 months
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.29%
1/346 • 36 months
|
|
Nervous system disorders
Cerebral infarction
|
0.87%
3/346 • 36 months
|
|
Nervous system disorders
Diabetic hyperosmolar coma
|
0.29%
1/346 • 36 months
|
|
Nervous system disorders
Neuroleptic malignant syndrome
|
0.58%
2/346 • 36 months
|
|
Nervous system disorders
Thalamus haemorrhage
|
0.29%
1/346 • 36 months
|
|
Cardiac disorders
Angina pectoris
|
0.29%
1/346 • 36 months
|
|
Cardiac disorders
Myocardial infarction
|
0.29%
1/346 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.29%
1/346 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.29%
1/346 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.87%
3/346 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.29%
1/346 • 36 months
|
|
Gastrointestinal disorders
Ileus
|
0.29%
1/346 • 36 months
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.29%
1/346 • 36 months
|
|
Hepatobiliary disorders
Jaundice
|
0.29%
1/346 • 36 months
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.29%
1/346 • 36 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.29%
1/346 • 36 months
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.29%
1/346 • 36 months
|
|
Renal and urinary disorders
Neurogenic bladder
|
0.29%
1/346 • 36 months
|
|
Renal and urinary disorders
Urinary retention
|
0.29%
1/346 • 36 months
|
|
Renal and urinary disorders
Renal impairment
|
0.29%
1/346 • 36 months
|
|
General disorders
Death
|
0.29%
1/346 • 36 months
|
|
General disorders
Hernia
|
0.29%
1/346 • 36 months
|
|
General disorders
Pyrexia
|
0.29%
1/346 • 36 months
|
|
Investigations
C-reactive protein increased
|
0.29%
1/346 • 36 months
|
|
Investigations
Platelet count decreased
|
0.29%
1/346 • 36 months
|
|
Investigations
White blood cell count increased
|
0.29%
1/346 • 36 months
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.29%
1/346 • 36 months
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.29%
1/346 • 36 months
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.29%
1/346 • 36 months
|
Other adverse events
| Measure |
Pramipexole
n=346 participants at risk
The drug was administered orally to patients according to the package insert in Japan. The drug form is only tablet. The initial dose was 0.125 mg twice a day, and was escalated in case of lack of efficacy. The maintenance dose was between 1.5 mg/day and 4.5 mg/day (0.5 mg - 1.5 mg three times a day).
|
|---|---|
|
Psychiatric disorders
Hallucination
|
8.1%
28/346 • 36 months
|
|
Nervous system disorders
Somnolence
|
17.1%
59/346 • 36 months
|
|
Gastrointestinal disorders
Constipation
|
7.2%
25/346 • 36 months
|
|
Gastrointestinal disorders
Nausea
|
5.8%
20/346 • 36 months
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
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