Trial Outcomes & Findings for Influence of Pramipexole Extended Release on Medication Adherence in Parkinson´s Disease (NCT NCT01097421)

NCT ID: NCT01097421

Last Updated: 2014-04-11

Results Overview

Morisky scale: 4 Yes/No Questions: Do you ever forget to take your medicine? Are you careless at times about taking your medicine? When you feel better do you sometimes stop taking your medicine? Sometimes if you feel worse when you take the medicine, do you stop taking it? Score one point for every NO: 0-1 points = low adherence, 2-3 points = moderate, 4 points = high adherence Confidence interval computed using the Clopper-Pearson (exact) method.

• Recruitment status: COMPLETED
• Target enrollment: 329 participants
• Primary outcome timeframe: 8-12 weeks
• Results posted on: 2014-04-11

Participant Flow

There were 328 patients entered and treated with a documented baseline observation in this study.

This was an open-label, prospective, non-controlled, non-interventional observational, post marketing surveillance study.

Participant milestones

Measure	Pramipexole Extended Release individual doses planned in the range of 0.26 mg (0.375 mg of salt) to 3.15 mg (4.5 mg of salt) of base per day
Overall Study STARTED	328
Overall Study COMPLETED	314
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Measure	Pramipexole Extended Release individual doses planned in the range of 0.26 mg (0.375 mg of salt) to 3.15 mg (4.5 mg of salt) of base per day
Overall Study Adverse Event	8
Overall Study Protocol Violation	2
Overall Study Lost to Follow-up	1
Overall Study Withdrawal by Subject	3

Baseline Characteristics

Influence of Pramipexole Extended Release on Medication Adherence in Parkinson´s Disease

Baseline characteristics by cohort

Measure	Pramipexole Extended Release n=326 Participants individual doses planned in the range of 0.26 mg (0.375 mg of salt) to 3.15 mg (4.5 mg of salt) of base per day
Age, Continuous	70.6 Years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	116 Participants n=5 Participants
Sex: Female, Male Male	210 Participants n=5 Participants

PRIMARY outcome

Timeframe: 8-12 weeks

Population: Full Analysis Set (FAS) defined as all patients who had taken at least one dose of the investigational medicinal product (IMP) and had a post-baseline assessment.

Morisky scale: 4 Yes/No Questions: Do you ever forget to take your medicine? Are you careless at times about taking your medicine? When you feel better do you sometimes stop taking your medicine? Sometimes if you feel worse when you take the medicine, do you stop taking it? Score one point for every NO: 0-1 points = low adherence, 2-3 points = moderate, 4 points = high adherence Confidence interval computed using the Clopper-Pearson (exact) method.

Outcome measures

Measure	Pramipexole Extended Release n=326 Participants individual doses planned in the range of 0.26 mg (0.375 mg of salt) to 3.15 mg (4.5 mg of salt) of base per day
Patients With a Score of 4 in Morisky Scale After 8-12 Weeks of Treatment	75.2 Percent 95% Confidence Interval (70.1, 79.8) • Interval 70.1 to 79.8

PRIMARY outcome

Timeframe: 8-12 weeks

Population: FAS

Points on Morisky scale

Outcome measures

Measure	Pramipexole Extended Release n=326 Participants individual doses planned in the range of 0.26 mg (0.375 mg of salt) to 3.15 mg (4.5 mg of salt) of base per day
Level of Adherence Low Adherence	4 Participants
Level of Adherence Moderate Adherence	77 Participants
Level of Adherence High Adherence	245 Participants

SECONDARY outcome

Timeframe: 8-12 weeks

Population: FAS

Patients were asked about their preference regarding frequency of intake (once daily or three times daily)

Outcome measures

Measure	Pramipexole Extended Release n=326 Participants individual doses planned in the range of 0.26 mg (0.375 mg of salt) to 3.15 mg (4.5 mg of salt) of base per day
Patient Preference Once daily intake	284 Participants
Patient Preference Three times daily intake	18 Participants
Patient Preference No difference	24 Participants

SECONDARY outcome

Timeframe: 8-12 weeks

Population: Safety Analysis Set (SAS) defined as all treated patients with a documented baseline observation.

Some patients had not related AEs as well as related AEs.

Outcome measures

Measure	Pramipexole Extended Release n=328 Participants individual doses planned in the range of 0.26 mg (0.375 mg of salt) to 3.15 mg (4.5 mg of salt) of base per day
Adverse Events (AE) Considered Related to Observed Medication related	20 Patients
Adverse Events (AE) Considered Related to Observed Medication not related	21 Patients
Adverse Events (AE) Considered Related to Observed Medication total AE - related and not related	39 Patients

SECONDARY outcome

Timeframe: pre-treatment and after 8-12 weeks

Population: FAS

mean Pramipexole (PPX) dose

Outcome measures

Measure	Pramipexole Extended Release n=326 Participants individual doses planned in the range of 0.26 mg (0.375 mg of salt) to 3.15 mg (4.5 mg of salt) of base per day
Pramipexole (PPX) Dose pre-treatment immediate release dose	1.07 mg/24 hr Standard Deviation 0.73
Pramipexole (PPX) Dose extended release dose at final observation	1.05 mg/24 hr Standard Deviation 0.75

SECONDARY outcome

Timeframe: 8-12 weeks

Population: FAS

Clinical Global Impression (CGI) scale at final visit

Outcome measures

Measure	Pramipexole Extended Release n=326 Participants individual doses planned in the range of 0.26 mg (0.375 mg of salt) to 3.15 mg (4.5 mg of salt) of base per day
Clinical Global Impressions (CGI) Very much improved	0 Participants
Clinical Global Impressions (CGI) Much improved	38 Participants
Clinical Global Impressions (CGI) Minimally improved	106 Participants
Clinical Global Impressions (CGI) No change	149 Participants
Clinical Global Impressions (CGI) Minimally worse	26 Participants
Clinical Global Impressions (CGI) Much worse	7 Participants
Clinical Global Impressions (CGI) Very much worse	0 Participants

SECONDARY outcome

Timeframe: 8-12 weeks

Population: FAS

Assessed by asking the patient at the final visit which alternative described how they had felt during the last 7 days as compared to how they felt at the baseline observation.

Outcome measures

Measure	Pramipexole Extended Release n=326 Participants individual doses planned in the range of 0.26 mg (0.375 mg of salt) to 3.15 mg (4.5 mg of salt) of base per day
Patients Global Impressions (PGI) Very much improved	3 Participants
Patients Global Impressions (PGI) Much improved	45 Participants
Patients Global Impressions (PGI) Minimally improved	91 Participants
Patients Global Impressions (PGI) No change	138 Participants
Patients Global Impressions (PGI) Minimally worse	39 Participants
Patients Global Impressions (PGI) Much worse	9 Participants
Patients Global Impressions (PGI) Very much worse	1 Participants

Adverse Events

Pramipexole Extended Release

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Pramipexole Extended Release n=328 participants at risk individual doses planned in the range of 0.26 mg (0.375 mg of salt) to 3.15 mg (4.5 mg of salt) of base per day
Cardiac disorders Atrial fibrillation	0.30% 1/328 • 8-12 weeks
Cardiac disorders Cardiac failure	0.30% 1/328 • 8-12 weeks
General disorders Sudden death	0.30% 1/328 • 8-12 weeks
Injury, poisoning and procedural complications Fall	0.30% 1/328 • 8-12 weeks
Injury, poisoning and procedural complications Tibia fracture	0.30% 1/328 • 8-12 weeks

Other adverse events

Adverse event data not reported

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim Pharmaceuticals

Phone: 1-800-243-0127

Email: clintriage.rdg@boehringer-ingelheim.com

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