Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is an open-label, prospective post marketing surveillance study to be performed in Sweden. Only data of patients idiopathic PD should be documented, in whom the treating physician plans to initiate a pharmacotherapy with PPX ER independent of this observational study. The questionnaires (Morisky Medication Adherence Measure, patient preference scale, CGI-I, PGI-I) will be used to document routine care in a standardized way and thus ensure high validity of the observational data. As the degree medication adherence of patients is routinely evaluated by their physicians, as is patient preference and possible symptom improvement after initiation of a new therapy, the patient questionnaires will be used to standardise medical routine care and to ensure validity of observational data.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient with parkinsons disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pramipexole Extended Release | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patients With a Score of 4 in Morisky Scale After 8-12 Weeks of Treatment | Morisky scale: 4 Yes/No Questions: Do you ever forget to take your medicine? Are you careless at times about taking your medicine? When you feel better do you sometimes stop taking your medicine? Sometimes if you feel worse when you take the medicine, do you stop taking it? Score one point for every NO: 0-1 points = low adherence, 2-3 points = moderate, 4 points = high adherence Confidence interval computed using the Clopper-Pearson (exact) method. | 8-12 weeks |
| Level of Adherence | Points on Morisky scale | 8-12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Preference | Patients were asked about their preference regarding frequency of intake (once daily or three times daily) | 8-12 weeks |
| Adverse Events (AE) Considered Related to Observed Medication |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
specialist care
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
Not provided
This was an open-label, prospective, non-controlled, non-interventional observational, post marketing surveillance study.
There were 328 patients entered and treated with a documented baseline observation in this study.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Pramipexole Extended Release | individual doses planned in the range of 0.26 mg (0.375 mg of salt) to 3.15 mg (4.5 mg of salt) of base per day |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Full analysis set (FAS)
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pramipexole Extended Release | individual doses planned in the range of 0.26 mg (0.375 mg of salt) to 3.15 mg (4.5 mg of salt) of base per day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Patients With a Score of 4 in Morisky Scale After 8-12 Weeks of Treatment | Morisky scale: 4 Yes/No Questions: Do you ever forget to take your medicine? Are you careless at times about taking your medicine? When you feel better do you sometimes stop taking your medicine? Sometimes if you feel worse when you take the medicine, do you stop taking it? Score one point for every NO: 0-1 points = low adherence, 2-3 points = moderate, 4 points = high adherence Confidence interval computed using the Clopper-Pearson (exact) method. | Full Analysis Set (FAS) defined as all patients who had taken at least one dose of the investigational medicinal product (IMP) and had a post-baseline assessment. | Posted | Number | 95% Confidence Interval | Percent | 8-12 weeks |
|
8-12 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pramipexole Extended Release | individual doses planned in the range of 0.26 mg (0.375 mg of salt) to 3.15 mg (4.5 mg of salt) of base per day |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Some patients had not related AEs as well as related AEs.
| 8-12 weeks |
| Pramipexole (PPX) Dose | mean Pramipexole (PPX) dose | pre-treatment and after 8-12 weeks |
| Clinical Global Impressions (CGI) | Clinical Global Impression (CGI) scale at final visit | 8-12 weeks |
| Patients Global Impressions (PGI) | Assessed by asking the patient at the final visit which alternative described how they had felt during the last 7 days as compared to how they felt at the baseline observation. | 8-12 weeks |
| Withdrawal by Subject |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | Level of Adherence | Points on Morisky scale | FAS | Posted | Number | Participants | 8-12 weeks |
|
|
|
| Secondary | Patient Preference | Patients were asked about their preference regarding frequency of intake (once daily or three times daily) | FAS | Posted | Number | Participants | 8-12 weeks |
|
|
|
| Secondary | Adverse Events (AE) Considered Related to Observed Medication | Some patients had not related AEs as well as related AEs. | Safety Analysis Set (SAS) defined as all treated patients with a documented baseline observation. | Posted | Number | Patients | 8-12 weeks |
|
|
|
| Secondary | Pramipexole (PPX) Dose | mean Pramipexole (PPX) dose | FAS | Posted | Mean | Standard Deviation | mg/24 hr | pre-treatment and after 8-12 weeks |
|
|
|
| Secondary | Clinical Global Impressions (CGI) | Clinical Global Impression (CGI) scale at final visit | FAS | Posted | Number | Participants | 8-12 weeks |
|
|
|
| Secondary | Patients Global Impressions (PGI) | Assessed by asking the patient at the final visit which alternative described how they had felt during the last 7 days as compared to how they felt at the baseline observation. | FAS | Posted | Number | Participants | 8-12 weeks |
|
|
|
| 3 |
| 328 |
| 0 |
| 328 |
| Cardiac failure | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Sudden death | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
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.
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| Measurements |
|---|
|
| No change |
|
| Minimally worse |
|
| Much worse |
|
| Very much worse |
|
| Measurements |
|---|
|
| No change |
|
| Minimally worse |
|
| Much worse |
|
| Very much worse |
|