Parkinson Disease
Conditions
Brief summary
The general aim of this study is to obtain long-term safety and tolerability data on pramipexole extended release (ER), in daily doses from 0.375mg to 4.5mg once daily (qd), in patients who have previously completed a pramipexole double-blind study in advanced Parkinson's disease (PD) (248.525 trial).
Interventions
DRUGPramipexole
Pramipexole ER 0.375 -4.5 mg
DRUGPlacebo
Placebo tablets identical to Pramipexole ER tablets
Sponsors
Boehringer Ingelheim
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
32 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Completion of the double-blind trial 248.525 2. Male or female patient with advanced idiopathic Parkinson's disease (PD), with a Modified Hoehn and Yahr stage of 2 to 4 at on-time, and a concomitant treatment with standard or controlled release L-Dopa+, or a combination of L-Dopa+ and entacapone. 3. Patient willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures. In particular the patient should be able to recognise the off-time and on-time periods during waking hours and the patient (or a family member or a guardian) should be able to record them accurately in the patient diary. 4. Signed informed consent obtained before any study procedures are carried out (in accordance with International Conference of Harmonization - Good Clinical Practice (ICH-GCP) guidelines and local legislation).
Exclusion criteria
1. Patients prematurely withdrawn from the double-blind trial 248.525 2. Atypical parkinsonian syndromes due to drugs, metabolic disorders, encephalitis or degenerative diseases 3. Any psychiatric disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV criteria that could prevent compliance or completion of the study and/or put the patient at risk if he/she takes part in the study 4. History of psychosis, except history of drug induced hallucinations 5. History of deep brain stimulation 6. Clinically significant ECG abnormalities at baseline 7. Clinically significant hypotension and/or symptomatic orthostatic hypotension at baseline 8. Malignant melanoma or history of previously treated malignant melanoma 9. Any other clinically significant disease, whether treated or not, that could put the patient at risk or could prevent compliance or completion of the study 10. Pregnancy or breast-feeding 11. Sexually active female of childbearing potential not using a medically approved method of birth control 12. Serum levels of aspartate transaminase (AST) (serum glutamic oxaloacetic transaminase (SGOT)), alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase) (SGPT)), alkaline phosphatase (AP) or bilirubin \> 2 upper limit normal (ULN) at baseline 13. Patients with a creatinine clearance \< 50 mL/min at baseline 14. Any medication with central dopaminergic antagonist activity within 4 weeks prior to the baseline visit 15. Any of the following drugs within 4 weeks prior to baseline visit: methylphenidate, cinnarizine, amphetamines 16. Flunarizine within 3 months prior to baseline 17. Known hypersensitivity to pramipexole or its excipients 18. Drug abuse, according to investigators judgement, within 2 years prior to baseline 19. Participation in investigational drug studies other than the trial 248.525, or use of other investigational drugs within one month or five times the half-life of the investigational drug (whichever is longer) prior to baseline
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events | 80 weeks | The aim of this study was to obtain long-term safety and tolerability data on pramipexole ER, in patients who have previously completed a pramipexole double blind study in advanced Parkinson's Disease (PD) (248.525 (NCT00466167)). Therefore these items were considered as a safety evaluation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patients Successfully Switched From Pramipexole (PPX) IR or ER to ER Assessed on UPDRS II+III | One week | Unified Parkinson's Disease Rating Scale (UPDRS) Successfully switched means: UPDRS II+III baseline score \>20 without a relative worsening of UPDRS II+III score \> 15% from baseline or UPDRS II+III baseline score \<=20 without an absolute worsening of UPDRS II+III score \> 3 from baseline UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms |
| UPDRS II+III Change From Open Label (OL) Baseline | OL Baseline and week 80 | UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms |
| Number of Participants With UPDRS II+III Response | Week 80 | A response means an improvement of \>=20% in UPDRS II+III from OL baseline UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms |
| Number of Patients Successfully Switched From PPX IR or ER to ER Assessed on Off-time | One week | A patient was considered as successfully switched if he/she has converted to ER without a worsening of off time by more than 12.5% from baseline. Off-time is based on patient diary data and describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease). |
| Percentage Off Time During Waking Hours Total Score: Change From Baseline | Baseline and week 80 | Percentage off-time based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease). A negative change implies improvement |
| Percentage on Time Without Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks | Baseline and week 80 | Percentage on-time based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. A positive change implies improvement. |
| Percentage on Time With Non Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks | Baseline and week 80 | Percentage on-time with non troublesome dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. A positive change implies improvement |
| Percentage on Time Without Dyskinesia or With Non Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks | Baseline and week 80 | Percentage on-time without dyskinesia or with non troublesome dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. A positive change implies improvement |
| Percentage on Time With Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks | Baseline and week 80 | Percentage on-time with troublesome dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. A positive change implies improvement |
| Number of Participants With Response in CGI-I | 32 weeks | Clinical Global Impression of Improvement (CGI-I), CGI-I scores ranging from '1' (very much improved) to '7' (very much worse). For patients previously treated with Placebo, all patients with at least much improved were considered as responders. For patients previously treated with PPX ER or IR, all patients with no change to very much improved were considered as responders |
| Number of Participants With Response in PGI-I | 32 weeks | Patient Global Impression of Improvement (PGI-I), PGI-I scores ranging from '1' (very much better) to '7' (very much worse). For patients previously treated with Placebo, all patients with at least much better were considered as responders. For patients previously treated with PPX ER or IR, all patients with no change to very much better were considered as responders |
| Number of Participants With Response in PGI-I for Early Morning Off Symptoms | 32 weeks | Patient Global Impression of Improvement (PGI-I) for early morning off symptoms, PGI-I scores ranging from '1' (very much better) to '7' (very much worse). For patients previously treated with Placebo, all patients with at least much better were considered as responders. For patients previously treated with PPX ER or IR, all patients with no change to very much better were considered as responders |
| UPDRS I Total Score and Change From OL Baseline at Week 80 | OL baseline and week 80 | UPDRS I ranging from 0 (normal) to 16 (severe). UPDRS I measures Mentation, Behavior and Mood |
| UPDRS II Total Score and Change From OL Baseline at Week 80 | OL baseline and week 80 | UPDRS II ranging from 0 (normal) to 52 (severe). UPDRS Part II is calculated as the average of UPDRS part II at on and UPDRS part II at off-period for each of the 13 activities |
| UPDRS III Total Score and Change From OL Baseline at Week 80 | OL baseline and week 80 | UPDRS III ranging from 0 (normal) to 108 (severe). UPDRS part III measures motor symptoms |
| Number of Participants With Response in Percentage Off Time During Waking Hours | 80 weeks | Response means \>=20% improvement relative to OL baseline in the % off-time during waking hours |
| Parkinson Fatigue Scale (PFS-16) Score and Change From OL Baseline at Week 80 | OL baseline and week 80 | PFS-16 (Parkinson fatigue scale) ranging from 16 (better perceived health status) to 80 (severe symptoms of the disease) measuring aspects of fatigue that are relevant to patients with PD |
| Number of Participants With L-dopa Daily Dose Change: Change From OL Baseline at Week 80 | OL baseline and week 80 | — |
| Number of Participants With Changes in Pramipexole Doses After 80 Weeks Compared to Pramipexole Dose at OL Baseline | OL baseline and week 80 | — |
| Number of Participants With Serious Adverse Events | 80 weeks | — |
| Supine Diastolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set | OL Baseline and Week 80 | — |
| Standing Diastolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set | OL Baseline and Week 80 | — |
| Supine Systolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set | OL Baseline and Week 80 | — |
| Standing Systolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set | OL Baseline and Week 80 | — |
| Supine Pulse Rate, Baseline and Week 80, Vital Signs Treated Set | OL Baseline and Week 80 | — |
| Standing Pulse Rate, Baseline and Week 80, Vital Signs Treated Set | OL Baseline and Week 80 | — |
| Body Weight of Female Patients, Baseline and Week 80, Vital Signs Treated Set | OL Baseline and Week 80 | — |
| Body Weight of Male Patients, Baseline and Week 80, Vital Signs Treated Set | OL Baseline and Week 80 | — |
| Epworth Sleepiness Scale (ESS), Baseline and End of Open Label, Treated Set | OL Baseline and Week 80 | ESS Total score ranges from zero (best) to 24 (worst); scale has 8 items, each rated from zero (no chance of dozing) to 3 (high chance of dozing) |
| Modified Minnesota Impulsive Disorder Interview (mMIDI), Frequency of Patients With at Least One Abnormal Behavior, Treated Set | Baseline, 80 weeks | The mMIDI is a semi-structured interview designed to assess impulsive control disorders. The scale was modified to focus behaviors of: pathological gambling, compulsive buying and compulsive sexual behavioral. |
| UPDRS IV Total Score and Change From OL Baseline at Week 80 | OL baseline and week 80 | UPDRS IV ranging from 0 (normal) to 23 (severe). UPDRS IV measures complications of therapy |
Countries
Austria, Czechia, Hungary, India, Italy, Philippines, Poland, Russia, Slovakia, South Korea, Spain, Sweden, Ukraine, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PPX ER (Previous Placebo) Pramipexole ER Treatment with placebo in previous trial | 129 |
| PPX ER (Previous PPX ER) Pramipexole ER Treatment with Pramipexole ER in previous trial | 123 |
| PPX ER (Previous PPX IR) Pramipexole ER Treatment with Pramipexole IR in previous trial | 139 |
| Total | 391 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 11 | 7 | 14 |
| Overall Study | Lost to Follow-up | 0 | 3 | 4 |
| Overall Study | Other | 0 | 3 | 2 |
| Overall Study | Protocol Violation | 0 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 5 | 5 | 6 |
Baseline characteristics
| Characteristic | PPX ER (Previous Placebo) | PPX ER (Previous PPX ER) | PPX ER (Previous PPX IR) | Total |
|---|---|---|---|---|
| Age, Continuous | 61.3 Years STANDARD_DEVIATION 9.7 | 61.7 Years STANDARD_DEVIATION 9.8 | 61.8 Years STANDARD_DEVIATION 9.7 | 61.6 Years STANDARD_DEVIATION 9.7 |
| Sex: Female, Male Female | 58 Participants | 55 Participants | 65 Participants | 178 Participants |
| Sex: Female, Male Male | 71 Participants | 68 Participants | 74 Participants | 213 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 87 / 129 | 74 / 123 | 81 / 139 | 242 / 391 |
| serious Total, serious adverse events | 14 / 129 | 11 / 123 | 14 / 139 | 39 / 391 |
Outcome results
Primary
Percentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events
The aim of this study was to obtain long-term safety and tolerability data on pramipexole ER, in patients who have previously completed a pramipexole double blind study in advanced Parkinson's Disease (PD) (248.525 (NCT00466167)). Therefore these items were considered as a safety evaluation.
Time frame: 80 weeks
Population: Patients from Treated Set (defined as all patients who were dispensed study drug and were documented to have at least one dose of investigational treatment)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PPX ER (Previous PPX ER) | Percentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events | Percentage of Patients with Serious Adverse Events | 10.9 Percentage of participants |
| PPX ER (Previous PPX ER) | Percentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events | Percentage of Patients with Adverse Drug Reactions | 52.7 Percentage of participants |
| PPX ER (Previous PPX ER) | Percentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events | Percentage of Patients with Adverse Events | 85.3 Percentage of participants |
| PPX ER (Previous PPX IR) | Percentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events | Percentage of Patients with Adverse Drug Reactions | 48.8 Percentage of participants |
| PPX ER (Previous PPX IR) | Percentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events | Percentage of Patients with Adverse Events | 83.7 Percentage of participants |
| PPX ER (Previous PPX IR) | Percentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events | Percentage of Patients with Serious Adverse Events | 8.9 Percentage of participants |
| PPX ER (Previous PPX IR) | Percentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events | Percentage of Patients with Adverse Events | 79.9 Percentage of participants |
| PPX ER (Previous PPX IR) | Percentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events | Percentage of Patients with Serious Adverse Events | 10.1 Percentage of participants |
| PPX ER (Previous PPX IR) | Percentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events | Percentage of Patients with Adverse Drug Reactions | 45.3 Percentage of participants |
Secondary
Body Weight of Female Patients, Baseline and Week 80, Vital Signs Treated Set
Time frame: OL Baseline and Week 80
Population: Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PPX ER (Previous PPX ER) | Body Weight of Female Patients, Baseline and Week 80, Vital Signs Treated Set | OL Baseline | 61.9 kg | Standard Deviation 13 |
| PPX ER (Previous PPX ER) | Body Weight of Female Patients, Baseline and Week 80, Vital Signs Treated Set | End of OL | 63.6 kg | Standard Deviation 13.8 |
| PPX ER (Previous PPX IR) | Body Weight of Female Patients, Baseline and Week 80, Vital Signs Treated Set | OL Baseline | 61.7 kg | Standard Deviation 14 |
| PPX ER (Previous PPX IR) | Body Weight of Female Patients, Baseline and Week 80, Vital Signs Treated Set | End of OL | 61.7 kg | Standard Deviation 15 |
| PPX ER (Previous PPX IR) | Body Weight of Female Patients, Baseline and Week 80, Vital Signs Treated Set | OL Baseline | 63.8 kg | Standard Deviation 14.6 |
| PPX ER (Previous PPX IR) | Body Weight of Female Patients, Baseline and Week 80, Vital Signs Treated Set | End of OL | 63.6 kg | Standard Deviation 16 |
Secondary
Body Weight of Male Patients, Baseline and Week 80, Vital Signs Treated Set
Time frame: OL Baseline and Week 80
Population: Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PPX ER (Previous PPX ER) | Body Weight of Male Patients, Baseline and Week 80, Vital Signs Treated Set | OL Baseline | 73.0 kg | Standard Deviation 15.7 |
| PPX ER (Previous PPX ER) | Body Weight of Male Patients, Baseline and Week 80, Vital Signs Treated Set | End of OL | 73.9 kg | Standard Deviation 16.4 |
| PPX ER (Previous PPX IR) | Body Weight of Male Patients, Baseline and Week 80, Vital Signs Treated Set | OL Baseline | 72.1 kg | Standard Deviation 12.2 |
| PPX ER (Previous PPX IR) | Body Weight of Male Patients, Baseline and Week 80, Vital Signs Treated Set | End of OL | 72.7 kg | Standard Deviation 12.5 |
| PPX ER (Previous PPX IR) | Body Weight of Male Patients, Baseline and Week 80, Vital Signs Treated Set | OL Baseline | 70.8 kg | Standard Deviation 13.2 |
| PPX ER (Previous PPX IR) | Body Weight of Male Patients, Baseline and Week 80, Vital Signs Treated Set | End of OL | 72.0 kg | Standard Deviation 14 |
Secondary
Epworth Sleepiness Scale (ESS), Baseline and End of Open Label, Treated Set
ESS Total score ranges from zero (best) to 24 (worst); scale has 8 items, each rated from zero (no chance of dozing) to 3 (high chance of dozing)
Time frame: OL Baseline and Week 80
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PPX ER (Previous PPX ER) | Epworth Sleepiness Scale (ESS), Baseline and End of Open Label, Treated Set | OL Baseline | 7.2 units on a scale | Standard Deviation 4.6 |
| PPX ER (Previous PPX ER) | Epworth Sleepiness Scale (ESS), Baseline and End of Open Label, Treated Set | Change from baseline at end of OL | 0.5 units on a scale | Standard Deviation 5.1 |
| PPX ER (Previous PPX IR) | Epworth Sleepiness Scale (ESS), Baseline and End of Open Label, Treated Set | OL Baseline | 8.1 units on a scale | Standard Deviation 4.1 |
| PPX ER (Previous PPX IR) | Epworth Sleepiness Scale (ESS), Baseline and End of Open Label, Treated Set | Change from baseline at end of OL | 1.2 units on a scale | Standard Deviation 4.7 |
| PPX ER (Previous PPX IR) | Epworth Sleepiness Scale (ESS), Baseline and End of Open Label, Treated Set | OL Baseline | 8.1 units on a scale | Standard Deviation 4.9 |
| PPX ER (Previous PPX IR) | Epworth Sleepiness Scale (ESS), Baseline and End of Open Label, Treated Set | Change from baseline at end of OL | 1.2 units on a scale | Standard Deviation 4.8 |
Secondary
Modified Minnesota Impulsive Disorder Interview (mMIDI), Frequency of Patients With at Least One Abnormal Behavior, Treated Set
The mMIDI is a semi-structured interview designed to assess impulsive control disorders. The scale was modified to focus behaviors of: pathological gambling, compulsive buying and compulsive sexual behavioral.
Time frame: Baseline, 80 weeks
Population: Treated Set - all patients dispensed drug and documented to have taken at least one dose
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PPX ER (Previous PPX ER) | Modified Minnesota Impulsive Disorder Interview (mMIDI), Frequency of Patients With at Least One Abnormal Behavior, Treated Set | Abnormal behavior - compulsive sexual behavior | 2 participants |
| PPX ER (Previous PPX ER) | Modified Minnesota Impulsive Disorder Interview (mMIDI), Frequency of Patients With at Least One Abnormal Behavior, Treated Set | Abnormal behavior - compulsive buying | 2 participants |
| PPX ER (Previous PPX ER) | Modified Minnesota Impulsive Disorder Interview (mMIDI), Frequency of Patients With at Least One Abnormal Behavior, Treated Set | Abnormal behavior - pathological gambling | 0 participants |
| PPX ER (Previous PPX IR) | Modified Minnesota Impulsive Disorder Interview (mMIDI), Frequency of Patients With at Least One Abnormal Behavior, Treated Set | Abnormal behavior - compulsive sexual behavior | 2 participants |
| PPX ER (Previous PPX IR) | Modified Minnesota Impulsive Disorder Interview (mMIDI), Frequency of Patients With at Least One Abnormal Behavior, Treated Set | Abnormal behavior - pathological gambling | 0 participants |
| PPX ER (Previous PPX IR) | Modified Minnesota Impulsive Disorder Interview (mMIDI), Frequency of Patients With at Least One Abnormal Behavior, Treated Set | Abnormal behavior - compulsive buying | 0 participants |
| PPX ER (Previous PPX IR) | Modified Minnesota Impulsive Disorder Interview (mMIDI), Frequency of Patients With at Least One Abnormal Behavior, Treated Set | Abnormal behavior - compulsive buying | 2 participants |
| PPX ER (Previous PPX IR) | Modified Minnesota Impulsive Disorder Interview (mMIDI), Frequency of Patients With at Least One Abnormal Behavior, Treated Set | Abnormal behavior - pathological gambling | 0 participants |
| PPX ER (Previous PPX IR) | Modified Minnesota Impulsive Disorder Interview (mMIDI), Frequency of Patients With at Least One Abnormal Behavior, Treated Set | Abnormal behavior - compulsive sexual behavior | 0 participants |
Secondary
Number of Participants With Changes in Pramipexole Doses After 80 Weeks Compared to Pramipexole Dose at OL Baseline
Time frame: OL baseline and week 80
Population: Patients from Treated Set (all patients who were dispensed study drug and were documented to have at least one dose of investigational treatment) and treated until week 80
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PPX ER (Previous PPX ER) | Number of Participants With Changes in Pramipexole Doses After 80 Weeks Compared to Pramipexole Dose at OL Baseline | Reduced | 56 Patients |
| PPX ER (Previous PPX ER) | Number of Participants With Changes in Pramipexole Doses After 80 Weeks Compared to Pramipexole Dose at OL Baseline | Increased | 29 Patients |
| PPX ER (Previous PPX ER) | Number of Participants With Changes in Pramipexole Doses After 80 Weeks Compared to Pramipexole Dose at OL Baseline | Unchanged | 40 Patients |
| PPX ER (Previous PPX IR) | Number of Participants With Changes in Pramipexole Doses After 80 Weeks Compared to Pramipexole Dose at OL Baseline | Reduced | 33 Patients |
| PPX ER (Previous PPX IR) | Number of Participants With Changes in Pramipexole Doses After 80 Weeks Compared to Pramipexole Dose at OL Baseline | Increased | 39 Patients |
| PPX ER (Previous PPX IR) | Number of Participants With Changes in Pramipexole Doses After 80 Weeks Compared to Pramipexole Dose at OL Baseline | Unchanged | 43 Patients |
| PPX ER (Previous PPX IR) | Number of Participants With Changes in Pramipexole Doses After 80 Weeks Compared to Pramipexole Dose at OL Baseline | Unchanged | 53 Patients |
| PPX ER (Previous PPX IR) | Number of Participants With Changes in Pramipexole Doses After 80 Weeks Compared to Pramipexole Dose at OL Baseline | Reduced | 26 Patients |
| PPX ER (Previous PPX IR) | Number of Participants With Changes in Pramipexole Doses After 80 Weeks Compared to Pramipexole Dose at OL Baseline | Increased | 47 Patients |
| Total PPX ER | Number of Participants With Changes in Pramipexole Doses After 80 Weeks Compared to Pramipexole Dose at OL Baseline | Reduced | 115 Patients |
| Total PPX ER | Number of Participants With Changes in Pramipexole Doses After 80 Weeks Compared to Pramipexole Dose at OL Baseline | Increased | 115 Patients |
| Total PPX ER | Number of Participants With Changes in Pramipexole Doses After 80 Weeks Compared to Pramipexole Dose at OL Baseline | Unchanged | 136 Patients |
Secondary
Number of Participants With L-dopa Daily Dose Change: Change From OL Baseline at Week 80
Time frame: OL baseline and week 80
Population: Patients from FAS with documentation of levodopa (L-DOPA) daily dose at week 80
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PPX ER (Previous PPX ER) | Number of Participants With L-dopa Daily Dose Change: Change From OL Baseline at Week 80 | No change | 93 Patients |
| PPX ER (Previous PPX ER) | Number of Participants With L-dopa Daily Dose Change: Change From OL Baseline at Week 80 | Increase | 8 Patients |
| PPX ER (Previous PPX ER) | Number of Participants With L-dopa Daily Dose Change: Change From OL Baseline at Week 80 | Decrease | 24 Patients |
| PPX ER (Previous PPX IR) | Number of Participants With L-dopa Daily Dose Change: Change From OL Baseline at Week 80 | No change | 84 Patients |
| PPX ER (Previous PPX IR) | Number of Participants With L-dopa Daily Dose Change: Change From OL Baseline at Week 80 | Decrease | 12 Patients |
| PPX ER (Previous PPX IR) | Number of Participants With L-dopa Daily Dose Change: Change From OL Baseline at Week 80 | Increase | 18 Patients |
| PPX ER (Previous PPX IR) | Number of Participants With L-dopa Daily Dose Change: Change From OL Baseline at Week 80 | Decrease | 12 Patients |
| PPX ER (Previous PPX IR) | Number of Participants With L-dopa Daily Dose Change: Change From OL Baseline at Week 80 | No change | 93 Patients |
| PPX ER (Previous PPX IR) | Number of Participants With L-dopa Daily Dose Change: Change From OL Baseline at Week 80 | Increase | 27 Patients |
| Total PPX ER | Number of Participants With L-dopa Daily Dose Change: Change From OL Baseline at Week 80 | Increase | 53 Patients |
| Total PPX ER | Number of Participants With L-dopa Daily Dose Change: Change From OL Baseline at Week 80 | No change | 270 Patients |
| Total PPX ER | Number of Participants With L-dopa Daily Dose Change: Change From OL Baseline at Week 80 | Decrease | 48 Patients |
Secondary
Number of Participants With Response in CGI-I
Clinical Global Impression of Improvement (CGI-I), CGI-I scores ranging from '1' (very much improved) to '7' (very much worse). For patients previously treated with Placebo, all patients with at least much improved were considered as responders. For patients previously treated with PPX ER or IR, all patients with no change to very much improved were considered as responders
Time frame: 32 weeks
Population: Patients from FAS with values of CGI-I at week 32
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PPX ER (Previous PPX ER) | Number of Participants With Response in CGI-I | 50 Patients |
| PPX ER (Previous PPX IR) | Number of Participants With Response in CGI-I | 106 Patients |
| PPX ER (Previous PPX IR) | Number of Participants With Response in CGI-I | 114 Patients |
| Total PPX ER | Number of Participants With Response in CGI-I | 270 Patients |
Secondary
Number of Participants With Response in Percentage Off Time During Waking Hours
Response means \>=20% improvement relative to OL baseline in the % off-time during waking hours
Time frame: 80 weeks
Population: Patients from FAS with values of off time during waking hours at 80 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PPX ER (Previous PPX ER) | Number of Participants With Response in Percentage Off Time During Waking Hours | 35 Patients |
| PPX ER (Previous PPX IR) | Number of Participants With Response in Percentage Off Time During Waking Hours | 40 Patients |
| PPX ER (Previous PPX IR) | Number of Participants With Response in Percentage Off Time During Waking Hours | 28 Patients |
| Total PPX ER | Number of Participants With Response in Percentage Off Time During Waking Hours | 103 Patients |
Secondary
Number of Participants With Response in PGI-I
Patient Global Impression of Improvement (PGI-I), PGI-I scores ranging from '1' (very much better) to '7' (very much worse). For patients previously treated with Placebo, all patients with at least much better were considered as responders. For patients previously treated with PPX ER or IR, all patients with no change to very much better were considered as responders
Time frame: 32 weeks
Population: Patients from FAS with values of PGI-I at week 32
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PPX ER (Previous PPX ER) | Number of Participants With Response in PGI-I | 45 Patients |
| PPX ER (Previous PPX IR) | Number of Participants With Response in PGI-I | 102 Patients |
| PPX ER (Previous PPX IR) | Number of Participants With Response in PGI-I | 113 Patients |
| Total PPX ER | Number of Participants With Response in PGI-I | 260 Patients |
Secondary
Number of Participants With Response in PGI-I for Early Morning Off Symptoms
Patient Global Impression of Improvement (PGI-I) for early morning off symptoms, PGI-I scores ranging from '1' (very much better) to '7' (very much worse). For patients previously treated with Placebo, all patients with at least much better were considered as responders. For patients previously treated with PPX ER or IR, all patients with no change to very much better were considered as responders
Time frame: 32 weeks
Population: Patients from FAS with values of PGI-I for early morning off symptoms at week 32
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PPX ER (Previous PPX ER) | Number of Participants With Response in PGI-I for Early Morning Off Symptoms | 45 Patients |
| PPX ER (Previous PPX IR) | Number of Participants With Response in PGI-I for Early Morning Off Symptoms | 103 Patients |
| PPX ER (Previous PPX IR) | Number of Participants With Response in PGI-I for Early Morning Off Symptoms | 112 Patients |
| Total PPX ER | Number of Participants With Response in PGI-I for Early Morning Off Symptoms | 260 Patients |
Secondary
Number of Participants With Serious Adverse Events
Time frame: 80 weeks
Population: The Treated Set (TS) included all patients who were dispensed study drug and were documented to have at least one dose of investigational treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PPX ER (Previous PPX ER) | Number of Participants With Serious Adverse Events | 14 Patients |
| PPX ER (Previous PPX IR) | Number of Participants With Serious Adverse Events | 11 Patients |
| PPX ER (Previous PPX IR) | Number of Participants With Serious Adverse Events | 14 Patients |
| Total PPX ER | Number of Participants With Serious Adverse Events | 39 Patients |
Secondary
Number of Participants With UPDRS II+III Response
A response means an improvement of \>=20% in UPDRS II+III from OL baseline UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms
Time frame: Week 80
Population: Patients from FAS with values of UPDRS II+III at week 80
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PPX ER (Previous PPX ER) | Number of Participants With UPDRS II+III Response | 35 Patients |
| PPX ER (Previous PPX IR) | Number of Participants With UPDRS II+III Response | 30 Patients |
| PPX ER (Previous PPX IR) | Number of Participants With UPDRS II+III Response | 31 Patients |
Secondary
Number of Patients Successfully Switched From PPX IR or ER to ER Assessed on Off-time
A patient was considered as successfully switched if he/she has converted to ER without a worsening of off time by more than 12.5% from baseline. Off-time is based on patient diary data and describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease).
Time frame: One week
Population: Patients from FAS and who maintain the final dose of the previous study
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PPX ER (Previous PPX ER) | Number of Patients Successfully Switched From PPX IR or ER to ER Assessed on Off-time | 57 Patients |
| PPX ER (Previous PPX IR) | Number of Patients Successfully Switched From PPX IR or ER to ER Assessed on Off-time | 70 Patients |
Secondary
Parkinson Fatigue Scale (PFS-16) Score and Change From OL Baseline at Week 80
PFS-16 (Parkinson fatigue scale) ranging from 16 (better perceived health status) to 80 (severe symptoms of the disease) measuring aspects of fatigue that are relevant to patients with PD
Time frame: OL baseline and week 80
Population: Patients from FAS with values of PFS-16 score at week 80
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| PPX ER (Previous PPX ER) | Parkinson Fatigue Scale (PFS-16) Score and Change From OL Baseline at Week 80 | -0.3 Unit on a scale | Standard Error 1.5 |
| PPX ER (Previous PPX IR) | Parkinson Fatigue Scale (PFS-16) Score and Change From OL Baseline at Week 80 | 3.8 Unit on a scale | Standard Error 1.6 |
| PPX ER (Previous PPX IR) | Parkinson Fatigue Scale (PFS-16) Score and Change From OL Baseline at Week 80 | 3.5 Unit on a scale | Standard Error 1.6 |
p-value: 0.0148ANCOVA
p-value: 0.0201ANCOVA
Secondary
Patients Successfully Switched From Pramipexole (PPX) IR or ER to ER Assessed on UPDRS II+III
Unified Parkinson's Disease Rating Scale (UPDRS) Successfully switched means: UPDRS II+III baseline score \>20 without a relative worsening of UPDRS II+III score \> 15% from baseline or UPDRS II+III baseline score \<=20 without an absolute worsening of UPDRS II+III score \> 3 from baseline UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms
Time frame: One week
Population: Patients from Full Analysis Set (FAS included all patients who were dispensed study medication, had received at least one dose of study drug and had provided any post-baseline efficacy assessment) and who maintain the final dose of the previous study
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PPX ER (Previous PPX ER) | Patients Successfully Switched From Pramipexole (PPX) IR or ER to ER Assessed on UPDRS II+III | 88 Patients |
| PPX ER (Previous PPX IR) | Patients Successfully Switched From Pramipexole (PPX) IR or ER to ER Assessed on UPDRS II+III | 106 Patients |
Secondary
Percentage Off Time During Waking Hours Total Score: Change From Baseline
Percentage off-time based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease). A negative change implies improvement
Time frame: Baseline and week 80
Population: Patients from FAS with values of UPDRS II+III at week 80
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| PPX ER (Previous PPX ER) | Percentage Off Time During Waking Hours Total Score: Change From Baseline | -1.5 percentage during waking hours | Standard Error 2 |
| PPX ER (Previous PPX IR) | Percentage Off Time During Waking Hours Total Score: Change From Baseline | -0.3 percentage during waking hours | Standard Error 2.1 |
| PPX ER (Previous PPX IR) | Percentage Off Time During Waking Hours Total Score: Change From Baseline | 1.7 percentage during waking hours | Standard Error 2 |
p-value: 0.559ANCOVA
p-value: 0.1289ANCOVA
Secondary
Percentage on Time With Non Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks
Percentage on-time with non troublesome dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. A positive change implies improvement
Time frame: Baseline and week 80
Population: Patients from FAS with values of on time during waking hours at week 80
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| PPX ER (Previous PPX ER) | Percentage on Time With Non Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks | 3.8 percentage during waking hours | Standard Error 1.8 |
| PPX ER (Previous PPX IR) | Percentage on Time With Non Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks | -2.7 percentage during waking hours | Standard Error 1.9 |
| PPX ER (Previous PPX IR) | Percentage on Time With Non Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks | 0.2 percentage during waking hours | Standard Error 1.8 |
p-value: 0.0009ANCOVA
p-value: 0.0573ANCOVA
Secondary
Percentage on Time Without Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks
Percentage on-time based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. A positive change implies improvement.
Time frame: Baseline and week 80
Population: Patients from FAS with values of on time during waking hours at week 80
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| PPX ER (Previous PPX ER) | Percentage on Time Without Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks | -1.6 percentage during waking hours | Standard Error 2.5 |
| PPX ER (Previous PPX IR) | Percentage on Time Without Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks | 2.9 percentage during waking hours | Standard Error 2.7 |
| PPX ER (Previous PPX IR) | Percentage on Time Without Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks | -2.0 percentage during waking hours | Standard Error 2.6 |
p-value: 0.1073ANCOVA
p-value: 0.8694ANCOVA
Secondary
Percentage on Time Without Dyskinesia or With Non Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks
Percentage on-time without dyskinesia or with non troublesome dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. A positive change implies improvement
Time frame: Baseline and week 80
Population: Patients from FAS with values of on time during waking hours at week 80
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| PPX ER (Previous PPX ER) | Percentage on Time Without Dyskinesia or With Non Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks | 1.8 percentage during waking hours | Standard Error 2.2 |
| PPX ER (Previous PPX IR) | Percentage on Time Without Dyskinesia or With Non Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks | 0.7 percentage during waking hours | Standard Error 2.3 |
| PPX ER (Previous PPX IR) | Percentage on Time Without Dyskinesia or With Non Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks | -0.9 percentage during waking hours | Standard Error 2.3 |
p-value: 0.6434ANCOVA
p-value: 0.2469ANCOVA
Secondary
Percentage on Time With Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks
Percentage on-time with troublesome dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. A positive change implies improvement
Time frame: Baseline and week 80
Population: Patients from FAS with values of on time during waking hours at week 80
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| PPX ER (Previous PPX ER) | Percentage on Time With Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks | -0.4 percentage during waking hours | Standard Error 1 |
| PPX ER (Previous PPX IR) | Percentage on Time With Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks | -0.3 percentage during waking hours | Standard Error 1.1 |
| PPX ER (Previous PPX IR) | Percentage on Time With Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks | -0.7 percentage during waking hours | Standard Error 1.1 |
p-value: 0.9741ANCOVA
p-value: 0.762ANCOVA
Secondary
Standing Diastolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set
Time frame: OL Baseline and Week 80
Population: Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PPX ER (Previous PPX ER) | Standing Diastolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set | OL Baseline | 77.8 mm Hg | Standard Deviation 9.2 |
| PPX ER (Previous PPX ER) | Standing Diastolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set | End of OL | 77.6 mm Hg | Standard Deviation 9.1 |
| PPX ER (Previous PPX IR) | Standing Diastolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set | OL Baseline | 77.3 mm Hg | Standard Deviation 9.1 |
| PPX ER (Previous PPX IR) | Standing Diastolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set | End of OL | 78.1 mm Hg | Standard Deviation 9.3 |
| PPX ER (Previous PPX IR) | Standing Diastolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set | OL Baseline | 77.6 mm Hg | Standard Deviation 9.9 |
| PPX ER (Previous PPX IR) | Standing Diastolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set | End of OL | 76.4 mm Hg | Standard Deviation 9.7 |
Secondary
Standing Pulse Rate, Baseline and Week 80, Vital Signs Treated Set
Time frame: OL Baseline and Week 80
Population: Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PPX ER (Previous PPX ER) | Standing Pulse Rate, Baseline and Week 80, Vital Signs Treated Set | OL Baseline | 78.3 beats per minute | Standard Deviation 10.7 |
| PPX ER (Previous PPX ER) | Standing Pulse Rate, Baseline and Week 80, Vital Signs Treated Set | End of OL | 79.3 beats per minute | Standard Deviation 8.7 |
| PPX ER (Previous PPX IR) | Standing Pulse Rate, Baseline and Week 80, Vital Signs Treated Set | OL Baseline | 78.0 beats per minute | Standard Deviation 9.5 |
| PPX ER (Previous PPX IR) | Standing Pulse Rate, Baseline and Week 80, Vital Signs Treated Set | End of OL | 77.7 beats per minute | Standard Deviation 7.5 |
| PPX ER (Previous PPX IR) | Standing Pulse Rate, Baseline and Week 80, Vital Signs Treated Set | OL Baseline | 77.7 beats per minute | Standard Deviation 9.9 |
| PPX ER (Previous PPX IR) | Standing Pulse Rate, Baseline and Week 80, Vital Signs Treated Set | End of OL | 78.8 beats per minute | Standard Deviation 10.4 |
Secondary
Standing Systolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set
Time frame: OL Baseline and Week 80
Population: Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PPX ER (Previous PPX ER) | Standing Systolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set | OL Baseline | 120.2 mm Hg | Standard Deviation 13.9 |
| PPX ER (Previous PPX ER) | Standing Systolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set | End of OL | 121.9 mm Hg | Standard Deviation 15 |
| PPX ER (Previous PPX IR) | Standing Systolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set | OL Baseline | 121.1 mm Hg | Standard Deviation 16.4 |
| PPX ER (Previous PPX IR) | Standing Systolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set | End of OL | 121.6 mm Hg | Standard Deviation 14.3 |
| PPX ER (Previous PPX IR) | Standing Systolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set | OL Baseline | 120.9 mm Hg | Standard Deviation 15.9 |
| PPX ER (Previous PPX IR) | Standing Systolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set | End of OL | 120.5 mm Hg | Standard Deviation 16 |
Secondary
Supine Diastolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set
Time frame: OL Baseline and Week 80
Population: Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PPX ER (Previous PPX ER) | Supine Diastolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set | OL Baseline | 77.4 mm Hg | Standard Deviation 8.9 |
| PPX ER (Previous PPX ER) | Supine Diastolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set | End of OL | 77.4 mm Hg | Standard Deviation 8.9 |
| PPX ER (Previous PPX IR) | Supine Diastolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set | OL Baseline | 77.3 mm Hg | Standard Deviation 8.6 |
| PPX ER (Previous PPX IR) | Supine Diastolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set | End of OL | 78.3 mm Hg | Standard Deviation 8.9 |
| PPX ER (Previous PPX IR) | Supine Diastolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set | OL Baseline | 77.6 mm Hg | Standard Deviation 9.4 |
| PPX ER (Previous PPX IR) | Supine Diastolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set | End of OL | 77.2 mm Hg | Standard Deviation 8.3 |
Secondary
Supine Pulse Rate, Baseline and Week 80, Vital Signs Treated Set
Time frame: OL Baseline and Week 80
Population: Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PPX ER (Previous PPX ER) | Supine Pulse Rate, Baseline and Week 80, Vital Signs Treated Set | OL Baseline | 73.6 beats per minute | Standard Deviation 9.6 |
| PPX ER (Previous PPX ER) | Supine Pulse Rate, Baseline and Week 80, Vital Signs Treated Set | End of OL | 75.8 beats per minute | Standard Deviation 9 |
| PPX ER (Previous PPX IR) | Supine Pulse Rate, Baseline and Week 80, Vital Signs Treated Set | OL Baseline | 72.6 beats per minute | Standard Deviation 9.2 |
| PPX ER (Previous PPX IR) | Supine Pulse Rate, Baseline and Week 80, Vital Signs Treated Set | End of OL | 74.2 beats per minute | Standard Deviation 7.9 |
| PPX ER (Previous PPX IR) | Supine Pulse Rate, Baseline and Week 80, Vital Signs Treated Set | OL Baseline | 73.2 beats per minute | Standard Deviation 9 |
| PPX ER (Previous PPX IR) | Supine Pulse Rate, Baseline and Week 80, Vital Signs Treated Set | End of OL | 74.4 beats per minute | Standard Deviation 10 |
Secondary
Supine Systolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set
Time frame: OL Baseline and Week 80
Population: Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PPX ER (Previous PPX ER) | Supine Systolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set | OL Baseline | 121.6 mm Hg | Standard Deviation 12.2 |
| PPX ER (Previous PPX ER) | Supine Systolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set | End of OL | 124.2 mm Hg | Standard Deviation 13.5 |
| PPX ER (Previous PPX IR) | Supine Systolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set | OL Baseline | 124.5 mm Hg | Standard Deviation 15.4 |
| PPX ER (Previous PPX IR) | Supine Systolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set | End of OL | 123.8 mm Hg | Standard Deviation 14.2 |
| PPX ER (Previous PPX IR) | Supine Systolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set | OL Baseline | 125.7 mm Hg | Standard Deviation 14.8 |
| PPX ER (Previous PPX IR) | Supine Systolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set | End of OL | 124.4 mm Hg | Standard Deviation 14.7 |
Secondary
UPDRS II+III Change From Open Label (OL) Baseline
UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms
Time frame: OL Baseline and week 80
Population: Patients from FAS with values of UPDRS II+III at week 80
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| PPX ER (Previous PPX ER) | UPDRS II+III Change From Open Label (OL) Baseline | -3.6 Scores on a scale | Standard Error 1.5 |
| PPX ER (Previous PPX IR) | UPDRS II+III Change From Open Label (OL) Baseline | 1.1 Scores on a scale | Standard Error 1.6 |
| PPX ER (Previous PPX IR) | UPDRS II+III Change From Open Label (OL) Baseline | 2.5 Scores on a scale | Standard Error 1.5 |
Comparison: PPX ER versus Placebop-value: 0.0039ANCOVA
Comparison: PPX IR versus Placebop-value: 0.0001ANCOVA
Secondary
UPDRS III Total Score and Change From OL Baseline at Week 80
UPDRS III ranging from 0 (normal) to 108 (severe). UPDRS part III measures motor symptoms
Time frame: OL baseline and week 80
Population: Patients from FAS with values of UPDRS III at week 80
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| PPX ER (Previous PPX ER) | UPDRS III Total Score and Change From OL Baseline at Week 80 | -3.1 units on a scale | Standard Error 1.1 |
| PPX ER (Previous PPX IR) | UPDRS III Total Score and Change From OL Baseline at Week 80 | 0.7 units on a scale | Standard Error 1.1 |
| PPX ER (Previous PPX IR) | UPDRS III Total Score and Change From OL Baseline at Week 80 | 1.3 units on a scale | Standard Error 1.1 |
p-value: 0.0015ANCOVA
p-value: 0.0002ANCOVA
Secondary
UPDRS II Total Score and Change From OL Baseline at Week 80
UPDRS II ranging from 0 (normal) to 52 (severe). UPDRS Part II is calculated as the average of UPDRS part II at on and UPDRS part II at off-period for each of the 13 activities
Time frame: OL baseline and week 80
Population: Patients from FAS with values of UPDRS II at week 80
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| PPX ER (Previous PPX ER) | UPDRS II Total Score and Change From OL Baseline at Week 80 | -0.4 units on a scale | Standard Error 0.5 |
| PPX ER (Previous PPX IR) | UPDRS II Total Score and Change From OL Baseline at Week 80 | 0.4 units on a scale | Standard Error 0.6 |
| PPX ER (Previous PPX IR) | UPDRS II Total Score and Change From OL Baseline at Week 80 | 1.0 units on a scale | Standard Error 0.5 |
p-value: 0.1713ANCOVA
p-value: 0.013ANCOVA
Secondary
UPDRS I Total Score and Change From OL Baseline at Week 80
UPDRS I ranging from 0 (normal) to 16 (severe). UPDRS I measures Mentation, Behavior and Mood
Time frame: OL baseline and week 80
Population: Patients from FAS with values of UPDRS I at week 80
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| PPX ER (Previous PPX ER) | UPDRS I Total Score and Change From OL Baseline at Week 80 | 0.1 units on a scale | Standard Error 0.2 |
| PPX ER (Previous PPX IR) | UPDRS I Total Score and Change From OL Baseline at Week 80 | 0.5 units on a scale | Standard Error 0.2 |
| PPX ER (Previous PPX IR) | UPDRS I Total Score and Change From OL Baseline at Week 80 | 0.5 units on a scale | Standard Error 0.2 |
p-value: 0.0831ANCOVA
p-value: 0.0759ANCOVA
Secondary
UPDRS IV Total Score and Change From OL Baseline at Week 80
UPDRS IV ranging from 0 (normal) to 23 (severe). UPDRS IV measures complications of therapy
Time frame: OL baseline and week 80
Population: Patients from FAS with values of UPDRS IV at week 80
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| PPX ER (Previous PPX ER) | UPDRS IV Total Score and Change From OL Baseline at Week 80 | 0.0 Unit on a scale | Standard Error 0.2 |
| PPX ER (Previous PPX IR) | UPDRS IV Total Score and Change From OL Baseline at Week 80 | -0.0 Unit on a scale | Standard Error 0.3 |
| PPX ER (Previous PPX IR) | UPDRS IV Total Score and Change From OL Baseline at Week 80 | 0.2 Unit on a scale | Standard Error 0.2 |
p-value: 0.876ANCOVA
p-value: 0.5113ANCOVA