Trial Outcomes & Findings for First Presentation of Parkinson Disease Patients to Neurologist (NCT NCT00802178)

Results Overview

Successful initiation was defined as a clinical assessment of efficacy by the neurologist rated at least as "good" on a 4 point scale after 4-8 weeks Mirapexin® treatment, where:1 = very good; 2 = good; 3 = moderate; and 4 = poor. De-novo patients were identified by: those who were referred: - if 'Reason for Referral' = 'initiation of therapy' or for 'diagnostic reason' and for those not referred: - if initial pharmacotherapy = 'Mirapexin® monotherapy' (i.e., no other anti Parkinson Disease (PD) therapy)

Recruitment status

COMPLETED

Target enrollment

2448 participants

Primary outcome timeframe

4 - 8 weeks

Results posted on

2014-04-11

Participant Flow

Participant milestones

Participant milestones
Measure	Mirapexin® (Pramipexole) The dose of Mirapexin® was selected by the neurologist upon his/her clinical judgement based on individual patient need and on recommendations given in the Mirapexin® Summary of Product Characteristics. mode of administration (admin.): Tablets for oral use
Overall Study STARTED	2448
Overall Study COMPLETED	2335
Overall Study NOT COMPLETED	113

Reasons for withdrawal

Reasons for withdrawal
Measure	Mirapexin® (Pramipexole) The dose of Mirapexin® was selected by the neurologist upon his/her clinical judgement based on individual patient need and on recommendations given in the Mirapexin® Summary of Product Characteristics. mode of administration (admin.): Tablets for oral use
Overall Study Lack of Efficacy	36
Overall Study Insufficient tolerability (IT)	17
Overall Study Withdrawal by Subject	18
Overall Study Other	32
Overall Study Lack of efficacy and patient wish	1
Overall Study IT and patient wish	8
Overall Study Patients wish and other reason	1

Baseline Characteristics

First Presentation of Parkinson Disease Patients to Neurologist

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mirapexin® (Pramipexole) n=2448 Participants The dose of Mirapexin® was selected by the neurologist upon his/her clinical judgement based on individual patient need and on recommendations given in the Mirapexin® Summary of Product Characteristics. mode of admin.: Tablets for oral use.
Age, Continuous	67.23 years n=5 Participants
Sex/Gender, Customized Female	1145 participants n=5 Participants
Sex/Gender, Customized Male	1274 participants n=5 Participants
Sex/Gender, Customized missing	29 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 - 8 weeks

Population: Full Analysis set (FAS) of De-novo patients in whom monotherapy with Mirapexin® could be successfully initiated

Successful initiation was defined as a clinical assessment of efficacy by the neurologist rated at least as "good" on a 4 point scale after 4-8 weeks Mirapexin® treatment, where:1 = very good; 2 = good; 3 = moderate; and 4 = poor. De-novo patients were identified by: those who were referred: - if 'Reason for Referral' = 'initiation of therapy' or for 'diagnostic reason' and for those not referred: - if initial pharmacotherapy = 'Mirapexin® monotherapy' (i.e., no other anti Parkinson Disease (PD) therapy)

Outcome measures

Outcome measures
Measure	Mirapexin® (Pramipexole) n=833 Participants The dose of Mirapexin® was selected by the neurologist upon his/her clinical judgement based on individual patient need and on recommendations given in the Mirapexin® Summary of Product Characteristics. mode of admin.: Tablets for oral use.
Number of De-novo Patients in Whom Monotherapy With Mirapexin® Could be Successfully Initiated Very good	403 Participants
Number of De-novo Patients in Whom Monotherapy With Mirapexin® Could be Successfully Initiated Good	323 Participants
Number of De-novo Patients in Whom Monotherapy With Mirapexin® Could be Successfully Initiated Moderate	73 Participants
Number of De-novo Patients in Whom Monotherapy With Mirapexin® Could be Successfully Initiated Poor	15 Participants
Number of De-novo Patients in Whom Monotherapy With Mirapexin® Could be Successfully Initiated Global Clinical Assessment (GCA) missing	19 Participants

SECONDARY outcome

Timeframe: Baseline and 4 to 8 weeks

Population: Full Analysis set (FAS)

Change in UPDRS Part I score from baseline to final visit. The score ranging from 0-16 (0= no disability, 16= maximum disability)

Outcome measures

Outcome measures
Measure	Mirapexin® (Pramipexole) n=2370 Participants The dose of Mirapexin® was selected by the neurologist upon his/her clinical judgement based on individual patient need and on recommendations given in the Mirapexin® Summary of Product Characteristics. mode of admin.: Tablets for oral use.
Change From Baseline in UPDRS (Unified Parkinson's Disease Rating Scale) Part I	-1.20 Unit on a scale

SECONDARY outcome

Timeframe: Baseline and 4 - 8 weeks

Population: Full Analysis set (FAS)

Change in UPDRS Part III score from baseline to final visit. Score ranging from 0 - 108 (0= no disability, 108 = worst disability).

Outcome measures

Outcome measures
Measure	Mirapexin® (Pramipexole) n=2370 Participants The dose of Mirapexin® was selected by the neurologist upon his/her clinical judgement based on individual patient need and on recommendations given in the Mirapexin® Summary of Product Characteristics. mode of admin.: Tablets for oral use.
Change From Baseline in UPDRS Part III	-11.18 Unit on a scale

SECONDARY outcome

Timeframe: 4 - 8 weeks

Population: Treated set (TS)

Successful initiation was defined as a clinical assessment of efficacy by the neurologist rated at least as "good" on a 4 point scale after 4-8 weeks Mirapexin® treatment, where:1 = very good; 2 = good; 3 = moderate; and 4 = poor.

Outcome measures

Outcome measures
Measure	Mirapexin® (Pramipexole) n=2448 Participants The dose of Mirapexin® was selected by the neurologist upon his/her clinical judgement based on individual patient need and on recommendations given in the Mirapexin® Summary of Product Characteristics. mode of admin.: Tablets for oral use.
Global Clinical Assessments of Efficacy of Mirapexin® for All Patients Very good	1043 Number of Participants
Global Clinical Assessments of Efficacy of Mirapexin® for All Patients Good	1004 Number of Participants
Global Clinical Assessments of Efficacy of Mirapexin® for All Patients Moderate	263 Number of Participants
Global Clinical Assessments of Efficacy of Mirapexin® for All Patients Poor	55 Number of Participants
Global Clinical Assessments of Efficacy of Mirapexin® for All Patients Global Clinical Assessment (GCA) missing	83 Number of Participants

Adverse Events

Mirapexin® (Pramipexole)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

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 Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
Publication restrictions are in place

Restriction type: OTHER