Trial Outcomes & Findings for Assessment of the Safety and Efficacy of Pramipexole Extended Release in Patients With Parkinson's Disease in Routine Clinical Practice (NCT NCT01061567)

Results Overview

The number of patients with any adverse events (AEs), patients with drug-related AEs.

Recruitment status

COMPLETED

Target enrollment

1814 participants

Primary outcome timeframe

From the treatment initiation to the end of study, on average 92.9 days

Results posted on

2014-07-08

Participant Flow

Participant milestones

Participant milestones
Measure	All Patients Patients with Parkinson's disease in routine clinical practice.
Overall Study STARTED	1814
Overall Study COMPLETED	1738
Overall Study NOT COMPLETED	76

Reasons for withdrawal

Reasons for withdrawal
Measure	All Patients Patients with Parkinson's disease in routine clinical practice.
Overall Study Adverse Event	32
Overall Study Death	2
Overall Study Lack of Efficacy	3
Overall Study Lost to Follow-up	24
Overall Study Protocol Violation	1
Overall Study Withdrawal by Subject	11
Overall Study Other reason than stated above	3

Baseline Characteristics

Assessment of the Safety and Efficacy of Pramipexole Extended Release in Patients With Parkinson's Disease in Routine Clinical Practice

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Patients n=1814 Participants Patients with Parkinson's disease in routine clinical practice.
Age, Continuous	68.8 years STANDARD_DEVIATION 9.2 • n=5 Participants
Gender Female	910 participants n=5 Participants
Gender Male	889 participants n=5 Participants

PRIMARY outcome

Timeframe: From the treatment initiation to the end of study, on average 92.9 days

Population: Patients from the Treated Set (TS).

The number of patients with any adverse events (AEs), patients with drug-related AEs.

Outcome measures

Outcome measures
Measure	All Patients n=1814 Participants Patients with Parkinson's disease in routine clinical practice.
Incidence of Adverse Events Patients with any AE	105 participants
Incidence of Adverse Events Patients with drug-related AEs	56 participants

PRIMARY outcome

Timeframe: 16 weeks

Population: Patients from the Treated Set (TS).

Patients who discontinued treatment due to adverse events including deaths.

Outcome measures

Outcome measures
Measure	All Patients n=1814 Participants Patients with Parkinson's disease in routine clinical practice.
Proportion of Patients With Withdrawals Due to Adverse Events.	0.019 proportion of participants

SECONDARY outcome

Timeframe: Baseline and the end of study (up to 16 weeks)

Population: Patients from the Full Analysis Set (FAS) which includes all treated patients who have data for at least one post baseline visit.

Mentation, behaviour and mood is scored from 0-16 in UPDRS I (0 = best score to 16 = worst score), result of motor examination scored from 0-108 in UPDRS III (0=no disability, 108=maximum disability) . The change was calculated by Baseline value minus value at visit 3. A decrease (change\>0) in the score means improvement.

Outcome measures

Outcome measures
Measure	All Patients n=1807 Participants Patients with Parkinson's disease in routine clinical practice.
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts I and III Total Score UPDRS Part I score (N=1756)	1.1 units on a scale Standard Deviation 1.6
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts I and III Total Score UPDRS Part III score (N=1670)	10.6 units on a scale Standard Deviation 9.4

SECONDARY outcome

Timeframe: Baseline and the end of study (up to 16 weeks)

Population: Patients from FAS

The CGI-I was rated (from 1: very much improved, to 7: very much worse) to assess the overall status of Parkinson's disease. The clinician rated how much a patient's condition had improved or worsened relative to baseline state. The patients are considered to be a CGI-I responder if they are rated at least by minimally improved.

Outcome measures

Outcome measures
Measure	All Patients n=1807 Participants Patients with Parkinson's disease in routine clinical practice.
Clinical Global Impression of Improvement (CGI-I) Responder Rate	84.3 percentage of participants

SECONDARY outcome

Timeframe: Baseline and the end of study (up to 16 weeks)

Population: Patients from FAS with evaluable data in VAS at baseline and at visit 3.

The visual analogue scale measures overall patient satisfaction with treatment on a continuous axis ranging from 0 (no satisfaction) to 100 (highest patient satisfaction). The change was calculated by the value at the final visit minus the value at baseline. Therefore, an increase (change\>0) reflects an improvement in patient satisfaction.

Outcome measures

Outcome measures
Measure	All Patients n=1657 Participants Patients with Parkinson's disease in routine clinical practice.
Change From Baseline in Visual Analogue Scale (VAS) of Patient Satisfaction	18.5 units on a scale Standard Deviation 22.6

SECONDARY outcome

Timeframe: Baseline and the end of study (up to 16 weeks)

Population: Patients from FAS with evaluable data in the Morisky scale for baseline and at visit 3.

The Morisky Medication Adherence Scale with 4 items was administered to examine medication adherence. The score ranges from 0 (best adherence) to 4 (worst adherence). The change was calculated by the value at baseline minus the value at visit 3. Therefore, a change \>0 reflects an improvement

Outcome measures

Outcome measures
Measure	All Patients n=1629 Participants Patients with Parkinson's disease in routine clinical practice.
Change From Baseline in Morisky Medication Adherence Scale (MMAS) 4 Item Score	0.6 units on a scale Standard Deviation 1.1

Adverse Events

All Patients

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	All Patients n=1814 participants at risk Patients with Parkinson's disease in routine clinical practice.
Nervous system disorders Cerebral insult	0.06% 1/1814 • From the treatment initiation to the end of study, on average 92.9 days
Psychiatric disorders Gambling	0.06% 1/1814 • From the treatment initiation to the end of study, on average 92.9 days
Respiratory, thoracic and mediastinal disorders Aspiration	0.06% 1/1814 • From the treatment initiation to the end of study, on average 92.9 days
Vascular disorders Heart failure	0.06% 1/1814 • From the treatment initiation to the end of study, on average 92.9 days

Other adverse events

Adverse event data not reported

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim Pharmaceuticals

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee There was no PI assigned for the overall study
Publication restrictions are in place

Restriction type: OTHER