Parkinson Disease
Conditions
Brief summary
The general aim of this study is to obtain long-term safety and tolerability data on pramipexole ER, in daily doses from 0.375mg to 4.5mg once daily (q.d), in patients who have previously completed a pramipexole double-blind study in early PD (248.524(NCT00479401) or 248.636(NCT00558025) trial).
Interventions
DRUGPlacebo
Patient to receive placebo tablets identical to Pramipexole ER tablets. Only during transfer phase.
DRUGPramipexole
ER 0.375-4,5 mg
Sponsors
Boehringer Ingelheim
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Completion of the double-blind trial 248.524 or 248.636 2. Male or female patient with early idiopathic Parkinson´s disease (PD), and with a Modified Hoehn and Yahr stage of I to III. 3. Patient willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures. 4. Signed informed consent obtained before any study procedures are carried out (in accordance with International Conference on Harmonisation (ICH) - Good Clinical Practice (GCP) guidelines and local legislation).
Exclusion criteria
1. Patients prematurely withdrawn from the double-blind trials 248.524 or 248.636. 2.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, fourth edition (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\. Clinically significant electrocardiogram (ECG) abnormalities at baseline. 6.Clinically significant hypotension 7.Malignant melanoma or history of previously treated malignant melanoma. 8.Any other clinically significant disease, that could put the patient at risk or could prevent compliance or completion of the study. 9. Pregnancy or breast-feeding. 10\. Sexually active female of childbearing potential not using a medically approved method of birth control for at least one month prior to the baseline and throughout the study.11 Serum levels of aspartate aminotransferase (AST) (SGOT), alanine aminotransferase (ALT) (SGPT), alkaline phosphatase or bilirubin \> 2 upper limit of normal (ULN) at baseline 12. Patients with a creatinine clearance \< 50 mL/min (estimated by the Cockcroft and Gault formula). 13. Motor complications under levodopa therapy (e.g. on-off phenomena, dyskinesia) at baseline. 14\. Any medication (including intra-muscular formulations) 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: methylphenidate, cinnarizine, amphetamines. 16. Flunarizine within 3 months prior to baseline. 17\. Known hypersensitivity to pramipexole or its excipients. 18. Drug abuse (including alcohol), according to investigator´s judgement, within 2 years prior to baseline. 19\. Participation in investigational drug studies other than trials 248.524 and 248.636 or use of other investigational drug within one month or five times the half-life of the investigational drug prior to baseline.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events | 80 weeks (patients from 248.524) or 72 weeks (patients from 248.636) | 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 early PD (248.524 (NCT00479401) or 248.636 (NCT00558025)). Therefore these items were considered as a safety evaluation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With UPDRS II+III Response From OL Baseline at Week 80 (Patients From 248.524) or Week 72 (Patients From 248.636) | OL Baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636) | A response means an improvement of \>=20% 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 |
| UPDRS I Total Score: Change From OL Baseline | OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636) | UPDRS I ranging from 0 (normal) to 16 (severe), measures Mentation, Behavior and Mood |
| UPDRS II Total Score: Change From OL Baseline | OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636) | UPDRS II ranging from 0 (normal) to 52 (severe), measures activity of daily living. |
| UPDRS III Total Score: Change From OL Baseline | OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636) | UPDRS III ranging from 0 (normal) to 108 (severe) measures motor symptoms |
| Response in Clinical Global Impression of Improvement (CGI-I) | OL Baseline and week 32 (patients from 248.524) or week 24 (patients from 248.636) | Clinicians evaluation in a rating scale of 7 steps, 1 meaning very much improved to 7 meaning 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 Pramipexole ER or Immediate Release (IR), all patients with no change to very much improved were considered as responders |
| Response in Patient Global Impression of Improvement (PGI-I) | OL Baseline and week 32 (patients from 248.524) or week 24 (patients from 248.636) | Patient rated evaluation of the PD symptoms on a rating scale of 7 steps, 1 meaning very much better to 7 meaning 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 pramipexole (PPX) ER or IR, all patients with no change to very much better were considered as responders |
| Unified Parkinson's Disease Rating Scale (UPDRS) II+III Total Score: Change From Baseline | Open Label (OL) baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636) | 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 Introducing L-Dopa Medication in OL Trial | 80 weeks (patients from 248.524) or 72 weeks (patients from 248.636) | Number of patients requiring Levodopa supplementation during the study |
| L-Dopa Dose: Change From OL Baseline | OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636) | Change from open-label baseline in Levodopa dose |
| Pramipexole Doses Respectively After 80 Weeks Compared to Pramipexole Doses at Week 8 for Previously 248.524 Patients and After 72 Weeks Compared to Pramipexole Doses at Week 0 for Previously 248.636 Patients | Week 8 and week 80 (patients from 248.524) or week 0 and week 72 (patients from 248.636) | Change from open-label baseline in Levodopa dose over the final 72 weeks of open-label assessment |
| Patient Preference Regarding Treatment Dosing | 80 weeks (patients from 248.524) or 72 weeks (patients from 248.636) | Patients were surveyed on their preference for Once Daily dosing versus Three Times Daily dosing |
| Patient Rating of Convenience of Treatment Dosing | 80 weeks (patients from 248.524) or 72 weeks (patients from 248.636) | Patients were surveyed on the convenience of Once Daily dosing versus Three Times Daily dosing |
| Parkinson Fatigue Scale (PFS-16) : Change From OL Baseline | OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636) | PFS-16 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. |
Countries
Austria, Czechia, Finland, France, Germany, Hungary, India, Japan, Malaysia, Netherlands, Russia, Slovakia, Taiwan, Ukraine, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients From 248.524 Patients who had previously completed 248.524 (NCT00479401) | 368 |
| Patients From 248.636 Patients who had previously completed 248.636 (NCT00558025) | 143 |
| Total | 511 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 42 | 14 |
| Overall Study | Lack of Efficacy | 3 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Other | 9 | 1 |
| Overall Study | Protocol Violation | 5 | 1 |
| Overall Study | Withdrawal by Subject | 18 | 9 |
Baseline characteristics
| Characteristic | Patients From 248.524 | Patients From 248.636 | Total |
|---|---|---|---|
| Age, Continuous | 62.2 Years STANDARD_DEVIATION 9.2 | 64.0 Years STANDARD_DEVIATION 9 | 62.7 Years STANDARD_DEVIATION 9.2 |
| Sex: Female, Male Female | 164 Participants | 62 Participants | 226 Participants |
| Sex: Female, Male Male | 204 Participants | 81 Participants | 285 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 214 / 368 | 62 / 143 |
| serious Total, serious adverse events | 53 / 368 | 21 / 143 |
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 early PD (248.524 (NCT00479401) or 248.636 (NCT00558025)). Therefore these items were considered as a safety evaluation
Time frame: 80 weeks (patients from 248.524) or 72 weeks (patients from 248.636)
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) |
|---|---|---|---|
| Patients From 248.524 | Percentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events | Percentage of Patients with Adverse Events | 84.5 Percentage of participants |
| Patients From 248.524 | Percentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events | Percentage of Patients with Adverse Drug Reactions | 45.7 Percentage of participants |
| Patients From 248.524 | Percentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events | Percentage of Patients with Serious Adverse Events | 14.4 Percentage of participants |
| Patients From 248.636 | Percentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events | Percentage of Patients with Adverse Events | 76.2 Percentage of participants |
| Patients From 248.636 | Percentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events | Percentage of Patients with Adverse Drug Reactions | 23.1 Percentage of participants |
| Patients From 248.636 | Percentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events | Percentage of Patients with Serious Adverse Events | 14.7 Percentage of participants |
Secondary
L-Dopa Dose: Change From OL Baseline
Change from open-label baseline in Levodopa dose
Time frame: OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)
Population: Patients from FAS and with L-Dopa at OL baseline and at week 80 (patients from 248.524) or week 72 (patients from 248.636)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients From 248.524 | L-Dopa Dose: Change From OL Baseline | Increase | 9 Patients |
| Patients From 248.524 | L-Dopa Dose: Change From OL Baseline | Decrease | 4 Patients |
| Patients From 248.524 | L-Dopa Dose: Change From OL Baseline | No change | 19 Patients |
| Patients From 248.636 | L-Dopa Dose: Change From OL Baseline | Decrease | 0 Patients |
| Patients From 248.636 | L-Dopa Dose: Change From OL Baseline | Increase | 23 Patients |
| Patients From 248.636 | L-Dopa Dose: Change From OL Baseline | No change | 41 Patients |
Secondary
Number of Patients Introducing L-Dopa Medication in OL Trial
Number of patients requiring Levodopa supplementation during the study
Time frame: 80 weeks (patients from 248.524) or 72 weeks (patients from 248.636)
Population: Patients from FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients From 248.524 | Number of Patients Introducing L-Dopa Medication in OL Trial | No | 320 Patients |
| Patients From 248.524 | Number of Patients Introducing L-Dopa Medication in OL Trial | Yes | 47 Patients |
| Patients From 248.636 | Number of Patients Introducing L-Dopa Medication in OL Trial | No | 117 Patients |
| Patients From 248.636 | Number of Patients Introducing L-Dopa Medication in OL Trial | Yes | 21 Patients |
Secondary
Number of Patients With UPDRS II+III Response From OL Baseline at Week 80 (Patients From 248.524) or Week 72 (Patients From 248.636)
A response means an improvement of \>=20% 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: OL Baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)
Population: Patients from Full Analysis Set (FAS included all patients who received at least one dose of study medication and had at least one post-baseline efficacy assessment) and who had values for UPDRS II+III at week 80 (patients from 248.524) or at week 72 (patients from 248.636)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients From 248.524 | Number of Patients With UPDRS II+III Response From OL Baseline at Week 80 (Patients From 248.524) or Week 72 (Patients From 248.636) | 73 Patients |
| Patients From 248.636 | Number of Patients With UPDRS II+III Response From OL Baseline at Week 80 (Patients From 248.524) or Week 72 (Patients From 248.636) | 27 Patients |
Secondary
Parkinson Fatigue Scale (PFS-16) : Change From OL Baseline
PFS-16 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 (patients from 248.524) or week 72 (patients from 248.636)
Population: Patients from FAS and who had values for PFS-16 at week 80 (patients from 248.524) or at week 72 (patients from 248.636)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients From 248.524 | Parkinson Fatigue Scale (PFS-16) : Change From OL Baseline | 2.0 Units of scale | Standard Deviation 12.5 |
| Patients From 248.636 | Parkinson Fatigue Scale (PFS-16) : Change From OL Baseline | 2.2 Units of scale | Standard Deviation 9.8 |
Secondary
Patient Preference Regarding Treatment Dosing
Patients were surveyed on their preference for Once Daily dosing versus Three Times Daily dosing
Time frame: 80 weeks (patients from 248.524) or 72 weeks (patients from 248.636)
Population: Patients from Full Analysis Set (FAS included all patients who received at least one dose of study medication and had at least one post-baseline efficacy assessment)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients From 248.524 | Patient Preference Regarding Treatment Dosing | Missing | 76 participants |
| Patients From 248.524 | Patient Preference Regarding Treatment Dosing | Prefer Once Daily dosing | 275 participants |
| Patients From 248.524 | Patient Preference Regarding Treatment Dosing | Prefer 3 Times Daily dosing | 9 participants |
| Patients From 248.524 | Patient Preference Regarding Treatment Dosing | No Preference | 7 participants |
| Patients From 248.636 | Patient Preference Regarding Treatment Dosing | No Preference | 4 participants |
| Patients From 248.636 | Patient Preference Regarding Treatment Dosing | Missing | 55 participants |
| Patients From 248.636 | Patient Preference Regarding Treatment Dosing | Prefer 3 Times Daily dosing | 1 participants |
| Patients From 248.636 | Patient Preference Regarding Treatment Dosing | Prefer Once Daily dosing | 78 participants |
Secondary
Patient Rating of Convenience of Treatment Dosing
Patients were surveyed on the convenience of Once Daily dosing versus Three Times Daily dosing
Time frame: 80 weeks (patients from 248.524) or 72 weeks (patients from 248.636)
Population: Patients from Full Analysis Set (FAS included all patients who received at least one dose of study medication and had at least one post-baseline efficacy assessment)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients From 248.524 | Patient Rating of Convenience of Treatment Dosing | Once Daily much more convenient | 196 participants |
| Patients From 248.524 | Patient Rating of Convenience of Treatment Dosing | Once Daily more convenient | 79 participants |
| Patients From 248.524 | Patient Rating of Convenience of Treatment Dosing | 3 Times Daily much more convenient | 2 participants |
| Patients From 248.524 | Patient Rating of Convenience of Treatment Dosing | 3 Times Daily more convenient | 6 participants |
| Patients From 248.524 | Patient Rating of Convenience of Treatment Dosing | No difference in preference | 7 participants |
| Patients From 248.524 | Patient Rating of Convenience of Treatment Dosing | Missing | 77 participants |
| Patients From 248.636 | Patient Rating of Convenience of Treatment Dosing | No difference in preference | 4 participants |
| Patients From 248.636 | Patient Rating of Convenience of Treatment Dosing | Once Daily much more convenient | 59 participants |
| Patients From 248.636 | Patient Rating of Convenience of Treatment Dosing | 3 Times Daily more convenient | 1 participants |
| Patients From 248.636 | Patient Rating of Convenience of Treatment Dosing | Once Daily more convenient | 19 participants |
| Patients From 248.636 | Patient Rating of Convenience of Treatment Dosing | Missing | 55 participants |
| Patients From 248.636 | Patient Rating of Convenience of Treatment Dosing | 3 Times Daily much more convenient | 0 participants |
Secondary
Pramipexole Doses Respectively After 80 Weeks Compared to Pramipexole Doses at Week 8 for Previously 248.524 Patients and After 72 Weeks Compared to Pramipexole Doses at Week 0 for Previously 248.636 Patients
Change from open-label baseline in Levodopa dose over the final 72 weeks of open-label assessment
Time frame: Week 8 and week 80 (patients from 248.524) or week 0 and week 72 (patients from 248.636)
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) and treated until week 80 (patients from 248.524) or week 72 (patients from 248.636)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients From 248.524 | Pramipexole Doses Respectively After 80 Weeks Compared to Pramipexole Doses at Week 8 for Previously 248.524 Patients and After 72 Weeks Compared to Pramipexole Doses at Week 0 for Previously 248.636 Patients | Decrease | 101 Patients |
| Patients From 248.524 | Pramipexole Doses Respectively After 80 Weeks Compared to Pramipexole Doses at Week 8 for Previously 248.524 Patients and After 72 Weeks Compared to Pramipexole Doses at Week 0 for Previously 248.636 Patients | Increase | 82 Patients |
| Patients From 248.524 | Pramipexole Doses Respectively After 80 Weeks Compared to Pramipexole Doses at Week 8 for Previously 248.524 Patients and After 72 Weeks Compared to Pramipexole Doses at Week 0 for Previously 248.636 Patients | No change | 156 Patients |
| Patients From 248.636 | Pramipexole Doses Respectively After 80 Weeks Compared to Pramipexole Doses at Week 8 for Previously 248.524 Patients and After 72 Weeks Compared to Pramipexole Doses at Week 0 for Previously 248.636 Patients | Decrease | 9 Patients |
| Patients From 248.636 | Pramipexole Doses Respectively After 80 Weeks Compared to Pramipexole Doses at Week 8 for Previously 248.524 Patients and After 72 Weeks Compared to Pramipexole Doses at Week 0 for Previously 248.636 Patients | Increase | 44 Patients |
| Patients From 248.636 | Pramipexole Doses Respectively After 80 Weeks Compared to Pramipexole Doses at Week 8 for Previously 248.524 Patients and After 72 Weeks Compared to Pramipexole Doses at Week 0 for Previously 248.636 Patients | No change | 73 Patients |
Secondary
Response in Clinical Global Impression of Improvement (CGI-I)
Clinicians evaluation in a rating scale of 7 steps, 1 meaning very much improved to 7 meaning 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 Pramipexole ER or Immediate Release (IR), all patients with no change to very much improved were considered as responders
Time frame: OL Baseline and week 32 (patients from 248.524) or week 24 (patients from 248.636)
Population: Patients from FAS and who had values for for CGI-I at week 32 (patients from 248.524) or at week 24 (patients from 248.636)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients From 248.524 | Response in Clinical Global Impression of Improvement (CGI-I) | 284 Patients |
| Patients From 248.636 | Response in Clinical Global Impression of Improvement (CGI-I) | 108 Patients |
Secondary
Response in Patient Global Impression of Improvement (PGI-I)
Patient rated evaluation of the PD symptoms on a rating scale of 7 steps, 1 meaning very much better to 7 meaning 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 pramipexole (PPX) ER or IR, all patients with no change to very much better were considered as responders
Time frame: OL Baseline and week 32 (patients from 248.524) or week 24 (patients from 248.636)
Population: Patients from FAS and who had values for for PGI-I at week 32 (patients from 248.524) or at week 24 (patients from 248.636)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients From 248.524 | Response in Patient Global Impression of Improvement (PGI-I) | 265 Patients |
| Patients From 248.636 | Response in Patient Global Impression of Improvement (PGI-I) | 111 Patients |
Secondary
Unified Parkinson's Disease Rating Scale (UPDRS) II+III Total Score: Change 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: Open Label (OL) baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)
Population: Patients from Full Analysis Set (FAS included all patients who received at least one dose of study medication and had at least one post-baseline efficacy assessment) and who had values for UPDRS II+III at week 80 (patients from 248.524) or at week 72 (patients from 248.636)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients From 248.524 | Unified Parkinson's Disease Rating Scale (UPDRS) II+III Total Score: Change From Baseline | 2.2 Units of scale | Standard Deviation 9.5 |
| Patients From 248.636 | Unified Parkinson's Disease Rating Scale (UPDRS) II+III Total Score: Change From Baseline | 1.5 Units of scale | Standard Deviation 7.7 |
Secondary
UPDRS III Total Score: Change From OL Baseline
UPDRS III ranging from 0 (normal) to 108 (severe) measures motor symptoms
Time frame: OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)
Population: Patients from FAS and who had values for UPDRS III at week 80 (patients from 248.524) or at week 72 (patients from 248.636)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients From 248.524 | UPDRS III Total Score: Change From OL Baseline | 1.1 Units of scale | Standard Deviation 7.2 |
| Patients From 248.636 | UPDRS III Total Score: Change From OL Baseline | 0.9 Units of scale | Standard Deviation 5.6 |
Secondary
UPDRS II Total Score: Change From OL Baseline
UPDRS II ranging from 0 (normal) to 52 (severe), measures activity of daily living.
Time frame: OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)
Population: Patients from FAS and who had values for UPDRS II at week 80 (patients from 248.524) or at week 72 (patients from 248.636)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients From 248.524 | UPDRS II Total Score: Change From OL Baseline | 1.0 Units of scale | Standard Deviation 3.2 |
| Patients From 248.636 | UPDRS II Total Score: Change From OL Baseline | 0.6 Units of scale | Standard Deviation 3.5 |
Secondary
UPDRS I Total Score: Change From OL Baseline
UPDRS I ranging from 0 (normal) to 16 (severe), measures Mentation, Behavior and Mood
Time frame: OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)
Population: Patients from FAS and who had values for UPDRS I at week 80 (patients from 248.524) or at week 72 (patients from 248.636)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients From 248.524 | UPDRS I Total Score: Change From OL Baseline | 0.3 Units of scale | Standard Deviation 1 |
| Patients From 248.636 | UPDRS I Total Score: Change From OL Baseline | 0.1 Units of scale | Standard Deviation 1.3 |