Parkinson Disease
Conditions
Brief summary
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.
Interventions
Sponsors
Boehringer Ingelheim
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients suffering from idiopathic PD who before inclusion into the observation had been planned to be treated with PPX ER according to the SP, and where decision of treatment was made independently of the patients¿ inclusion into this observational study 2. Stable dose of PPX IR for at least 4 weeks before inclusion into the observation 3. Male or female PD patients aged at least 30 4. Ability to reliably complete self-rating scales (Morisky Medication Adherence Measure, patient preference scale) according to the physician¿s judgement 5. Written informed consent by the patient for study participation.
Exclusion criteria
1. Patients who are not able to understand the questionnaires (e.g. due to mental impairment or language problems) according to the physician¿s judgement. 2. Any contraindications against PPX ER according to the Summary of Product Characteristics (SPC).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patients With a Score of 4 in Morisky Scale After 8-12 Weeks of Treatment | 8-12 weeks | 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. |
| Level of Adherence | 8-12 weeks | Points on Morisky scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pramipexole (PPX) Dose | pre-treatment and after 8-12 weeks | mean Pramipexole (PPX) dose |
| Patient Preference | 8-12 weeks | Patients were asked about their preference regarding frequency of intake (once daily or three times daily) |
| Patients Global Impressions (PGI) | 8-12 weeks | 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. |
| Clinical Global Impressions (CGI) | 8-12 weeks | Clinical Global Impression (CGI) scale at final visit |
| Adverse Events (AE) Considered Related to Observed Medication | 8-12 weeks | Some patients had not related AEs as well as related AEs. |
Participant flow
Recruitment details
There were 328 patients entered and treated with a documented baseline observation in this study.
Pre-assignment details
This was an open-label, prospective, non-controlled, non-interventional observational, post marketing surveillance study.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 326 |
| Total | 326 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 8 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Protocol Violation | 2 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Pramipexole Extended Release |
|---|---|
| Age, Continuous | 70.6 Years STANDARD_DEVIATION 9.5 |
| Sex: Female, Male Female | 116 Participants |
| Sex: Female, Male Male | 210 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 328 |
| serious Total, serious adverse events | 3 / 328 |
Outcome results
Primary
Level of Adherence
Points on Morisky scale
Time frame: 8-12 weeks
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pramipexole Extended Release | Level of Adherence | Low Adherence | 4 Participants |
| Pramipexole Extended Release | Level of Adherence | Moderate Adherence | 77 Participants |
| Pramipexole Extended Release | Level of Adherence | High Adherence | 245 Participants |
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.
Time frame: 8-12 weeks
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pramipexole Extended Release | Patients With a Score of 4 in Morisky Scale After 8-12 Weeks of Treatment | 75.2 Percent |
Secondary
Adverse Events (AE) Considered Related to Observed Medication
Some patients had not related AEs as well as related AEs.
Time frame: 8-12 weeks
Population: Safety Analysis Set (SAS) defined as all treated patients with a documented baseline observation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pramipexole Extended Release | Adverse Events (AE) Considered Related to Observed Medication | related | 20 Patients |
| Pramipexole Extended Release | Adverse Events (AE) Considered Related to Observed Medication | not related | 21 Patients |
| Pramipexole Extended Release | Adverse Events (AE) Considered Related to Observed Medication | total AE - related and not related | 39 Patients |
Secondary
Clinical Global Impressions (CGI)
Clinical Global Impression (CGI) scale at final visit
Time frame: 8-12 weeks
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pramipexole Extended Release | Clinical Global Impressions (CGI) | Very much improved | 0 Participants |
| Pramipexole Extended Release | Clinical Global Impressions (CGI) | Much improved | 38 Participants |
| Pramipexole Extended Release | Clinical Global Impressions (CGI) | Minimally improved | 106 Participants |
| Pramipexole Extended Release | Clinical Global Impressions (CGI) | No change | 149 Participants |
| Pramipexole Extended Release | Clinical Global Impressions (CGI) | Minimally worse | 26 Participants |
| Pramipexole Extended Release | Clinical Global Impressions (CGI) | Much worse | 7 Participants |
| Pramipexole Extended Release | Clinical Global Impressions (CGI) | Very much worse | 0 Participants |
Secondary
Patient Preference
Patients were asked about their preference regarding frequency of intake (once daily or three times daily)
Time frame: 8-12 weeks
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pramipexole Extended Release | Patient Preference | Once daily intake | 284 Participants |
| Pramipexole Extended Release | Patient Preference | Three times daily intake | 18 Participants |
| Pramipexole Extended Release | Patient Preference | No difference | 24 Participants |
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.
Time frame: 8-12 weeks
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pramipexole Extended Release | Patients Global Impressions (PGI) | Very much improved | 3 Participants |
| Pramipexole Extended Release | Patients Global Impressions (PGI) | Much improved | 45 Participants |
| Pramipexole Extended Release | Patients Global Impressions (PGI) | Minimally improved | 91 Participants |
| Pramipexole Extended Release | Patients Global Impressions (PGI) | No change | 138 Participants |
| Pramipexole Extended Release | Patients Global Impressions (PGI) | Minimally worse | 39 Participants |
| Pramipexole Extended Release | Patients Global Impressions (PGI) | Much worse | 9 Participants |
| Pramipexole Extended Release | Patients Global Impressions (PGI) | Very much worse | 1 Participants |
Secondary
Pramipexole (PPX) Dose
mean Pramipexole (PPX) dose
Time frame: pre-treatment and after 8-12 weeks
Population: FAS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pramipexole Extended Release | Pramipexole (PPX) Dose | pre-treatment immediate release dose | 1.07 mg/24 hr | Standard Deviation 0.73 |
| Pramipexole Extended Release | Pramipexole (PPX) Dose | extended release dose at final observation | 1.05 mg/24 hr | Standard Deviation 0.75 |