Trial Outcomes & Findings for Observational Study With Neupro® to Evaluate the Patient´s Perception of Pain Associated With Parkinson´s Disease (NCT NCT01606670)

NCT ID: NCT01606670

Last Updated: 2018-04-04

Results Overview

The Pain Description List (SBL, question 10) is part of the validated German Pain Questionnaire (DSF). The SBL consists of a 12 item list of adjectives. Each adjective is ranked from 0 (not applicable) to 3 (exactly applicable). 8 of the 12 adjectives will be used to assess the sensory items of pain and 4 adjectives to describe the affective items of pain. The 8 sensory items are used to assess qualitative description of pain. For the 4 affective pain items, a sum score ranges from 0 (not applicable) to 12 (exactly applicable). Values above 8 can be considered noticeable.

Recruitment status

COMPLETED

Target enrollment

93 participants

Primary outcome timeframe

From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®)

Results posted on

2018-04-04

Participant Flow

The study started to enroll subjects in May 2012. Overall, 28 sites enrolled 93 patients in this study.

Participant Flow refers to the Enrolled Set (ES).

Participant milestones

Participant milestones
Measure	Neupro® Treatment Routine treatment with Neupro® (2, 4, 6, 8, 10, 12, 14, 16 mg/24 h) as per approved label in the EU, which is applicable in the EU member states Germany and Austria.
Overall Study STARTED	93
Overall Study Safety Set	93
Overall Study Full Analysis Set	70
Overall Study COMPLETED	77
Overall Study NOT COMPLETED	16

Reasons for withdrawal

Reasons for withdrawal
Measure	Neupro® Treatment Routine treatment with Neupro® (2, 4, 6, 8, 10, 12, 14, 16 mg/24 h) as per approved label in the EU, which is applicable in the EU member states Germany and Austria.
Overall Study Adverse Event	6
Overall Study Lack of Efficacy	2
Overall Study Lost to Follow-up	3
Overall Study Withdrawal by Subject	3
Overall Study Other Reason	2

Baseline Characteristics

Observational Study With Neupro® to Evaluate the Patient´s Perception of Pain Associated With Parkinson´s Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Neupro® Treatment n=93 Participants Routine treatment with Neupro® (2, 4, 6, 8, 10, 12, 14, 16 mg/24 h) as per approved label in the EU, which is applicable in the EU member states Germany and Austria.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=99 Participants
Age, Categorical >=65 years	76 Participants n=99 Participants
Age, Continuous	71.1 years STANDARD_DEVIATION 9.0 • n=99 Participants
Sex: Female, Male Female	45 Participants n=99 Participants
Sex: Female, Male Male	48 Participants n=99 Participants
Region of Enrollment Austria	6 participants n=99 Participants
Region of Enrollment Germany	87 participants n=99 Participants

PRIMARY outcome

Timeframe: From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®)

Population: Full Analysis Set (FAS). The FAS includes all enrolled patients who had applied the rotigotine transdermal patch at least once and for whom valid data for the primary effectiveness variable were available from Baseline and a subsequent routine visit.

The Pain Description List (SBL, question 10) is part of the validated German Pain Questionnaire (DSF). The SBL consists of a 12 item list of adjectives. Each adjective is ranked from 0 (not applicable) to 3 (exactly applicable). 8 of the 12 adjectives will be used to assess the sensory items of pain and 4 adjectives to describe the affective items of pain. The 8 sensory items are used to assess qualitative description of pain. For the 4 affective pain items, a sum score ranges from 0 (not applicable) to 12 (exactly applicable). Values above 8 can be considered noticeable.

Outcome measures

Outcome measures
Measure	Neupro® Treatment n=70 Participants Routine treatment with Neupro® (2, 4, 6, 8, 10, 12, 14, 16 mg/24 h) as per approved label in the EU, which is applicable in the EU member states Germany and Austria.
Change From Baseline to Visit 2 in the Sum Score Calculated From the 4 Items of the Affective Dimension of the Pain Description List (Schmerzbeschreibungsliste SBL, Question 10) of the German Pain Questionnaire	-1.3 units on a scale Standard Deviation 2.8

SECONDARY outcome

Timeframe: From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®)

Population: Of the 70 patients in the Full Analysis Set (FAS), 68 patients had complete data for UPDRS Part II and are included in the analysis of this outcome measure.

The UPDRS is a scale for the assessment of function in Parkinson's disease. Part II measures 'Activities of Daily Living'. It consists of 13 questions, each ranging from 0 (none) to 4 (severe abnormalities). The sum score of the UPDRS Part II ranges from 0 (normal) to 52 (worst score possible).

Outcome measures

Outcome measures
Measure	Neupro® Treatment n=68 Participants Routine treatment with Neupro® (2, 4, 6, 8, 10, 12, 14, 16 mg/24 h) as per approved label in the EU, which is applicable in the EU member states Germany and Austria.
Change From Baseline to Visit 2 in the Sum Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II	-1.3 units on a scale Standard Deviation 4.3

SECONDARY outcome

Timeframe: From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®)

Population: Of the 70 patients in the Full Analysis Set (FAS), 67 patients had complete data for UPDRS Part III and are included in the analysis of this outcome measure.

The UPDRS is a scale for the assessment of function in Parkinson's disease. Part III measures 'Motor Function'. It consists of 14 items with 27 questions, each ranging from 0 (normal) to 4 (severe abnormalities). The sum score of the UPDRS Part III ranges from 0 (normal) to 108 (worst score possible).

Outcome measures

Outcome measures
Measure	Neupro® Treatment n=67 Participants Routine treatment with Neupro® (2, 4, 6, 8, 10, 12, 14, 16 mg/24 h) as per approved label in the EU, which is applicable in the EU member states Germany and Austria.
Change From Baseline to Visit 2 in the Sum Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part III	-3.9 units on a scale Standard Deviation 7.6

SECONDARY outcome

Timeframe: From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®)

Population: Of the 70 patients in the Full Analysis Set (FAS), 68 patients had complete data for UPDRS Part II and 67 patients had complete data for UPDRS Part III. Thus, of the 70 patients in the FAS, 67 patients are included in the analysis of this outcome measure.

The UPDRS is a scale for the assessment of function in Parkinson's disease. Part II measures 'Activities of Daily Living' and Part III 'Motor Function'. They consist of 40 questions, each ranging from 0 (normal) to 4 (severe abnormalities). The sum score of the UPDRS Part II+III ranges from 0 (normal) to 160 (worst score possible).

Outcome measures

Outcome measures
Measure	Neupro® Treatment n=67 Participants Routine treatment with Neupro® (2, 4, 6, 8, 10, 12, 14, 16 mg/24 h) as per approved label in the EU, which is applicable in the EU member states Germany and Austria.
Change From Baseline to Visit 2 in the Sum Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III	-5.3 units on a scale Standard Deviation 10.5

SECONDARY outcome

Timeframe: From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®)

Population: Full Analysis Set (FAS). The FAS includes all enrolled patients who had applied the rotigotine transdermal patch at least once and for whom valid data for the primary effectiveness variable were available from Baseline and a subsequent routine visit.

The PDQ-8 is a self-administered 8 item questionnaire that assesses the overall health status. The questions will be rated from 0 (never) to 4 (always \[or cannot do at all\]). The total score ranges from 0 (never) to 32 (always \[or cannot do at all\]) with lower scores indicating a better health status.

Outcome measures

Outcome measures
Measure	Neupro® Treatment n=70 Participants Routine treatment with Neupro® (2, 4, 6, 8, 10, 12, 14, 16 mg/24 h) as per approved label in the EU, which is applicable in the EU member states Germany and Austria.
Change From Baseline to Visit 2 in the Short-form Parkinson's Disease Questionnaire (PDQ-8) Total Score	-2.0 units on a scale Standard Deviation 4.8

Adverse Events

Neupro® Treatment

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Neupro® Treatment n=93 participants at risk Routine treatment with Neupro® (2, 4, 6, 8, 10, 12, 14, 16 mg/24 h) as per approved label in the EU, which is applicable in the EU member states Germany and Austria.
Ear and labyrinth disorders VERTIGO	1.1% 1/93 • Number of events 1 • Adverse Events were collected over the whole study from Visit 1 (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro). Since this was a NIS with no safety objectives, only the related adverse events (AEs), ie, adverse drug reactions (ADRs), were documented.
Gastrointestinal disorders NAUSEA	1.1% 1/93 • Number of events 1 • Adverse Events were collected over the whole study from Visit 1 (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro). Since this was a NIS with no safety objectives, only the related adverse events (AEs), ie, adverse drug reactions (ADRs), were documented.
General disorders APPLICATION SITE ERYTHEMA	1.1% 1/93 • Number of events 1 • Adverse Events were collected over the whole study from Visit 1 (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro). Since this was a NIS with no safety objectives, only the related adverse events (AEs), ie, adverse drug reactions (ADRs), were documented.
General disorders APPLICATION SITE HYPERSENSITIVITY	1.1% 1/93 • Number of events 1 • Adverse Events were collected over the whole study from Visit 1 (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro). Since this was a NIS with no safety objectives, only the related adverse events (AEs), ie, adverse drug reactions (ADRs), were documented.
Nervous system disorders HEADACHE	1.1% 1/93 • Number of events 1 • Adverse Events were collected over the whole study from Visit 1 (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro). Since this was a NIS with no safety objectives, only the related adverse events (AEs), ie, adverse drug reactions (ADRs), were documented.
Nervous system disorders DIZZINESS	1.1% 1/93 • Number of events 1 • Adverse Events were collected over the whole study from Visit 1 (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro). Since this was a NIS with no safety objectives, only the related adverse events (AEs), ie, adverse drug reactions (ADRs), were documented.
Psychiatric disorders HALLUCINATION	1.1% 1/93 • Number of events 1 • Adverse Events were collected over the whole study from Visit 1 (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro). Since this was a NIS with no safety objectives, only the related adverse events (AEs), ie, adverse drug reactions (ADRs), were documented.
Psychiatric disorders HALLUCINATION, VISUAL	1.1% 1/93 • Number of events 1 • Adverse Events were collected over the whole study from Visit 1 (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro). Since this was a NIS with no safety objectives, only the related adverse events (AEs), ie, adverse drug reactions (ADRs), were documented.
Psychiatric disorders SLEEP DISORDER	1.1% 1/93 • Number of events 1 • Adverse Events were collected over the whole study from Visit 1 (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro). Since this was a NIS with no safety objectives, only the related adverse events (AEs), ie, adverse drug reactions (ADRs), were documented.
Skin and subcutaneous tissue disorders PRURITUS	3.2% 3/93 • Number of events 3 • Adverse Events were collected over the whole study from Visit 1 (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro). Since this was a NIS with no safety objectives, only the related adverse events (AEs), ie, adverse drug reactions (ADRs), were documented.
Skin and subcutaneous tissue disorders PRURITUS GENERALISED	1.1% 1/93 • Number of events 1 • Adverse Events were collected over the whole study from Visit 1 (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro). Since this was a NIS with no safety objectives, only the related adverse events (AEs), ie, adverse drug reactions (ADRs), were documented.
Skin and subcutaneous tissue disorders ERYTHEMA	1.1% 1/93 • Number of events 1 • Adverse Events were collected over the whole study from Visit 1 (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro). Since this was a NIS with no safety objectives, only the related adverse events (AEs), ie, adverse drug reactions (ADRs), were documented.
Skin and subcutaneous tissue disorders GENERALISED ERYTHEMA	1.1% 1/93 • Number of events 1 • Adverse Events were collected over the whole study from Visit 1 (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro). Since this was a NIS with no safety objectives, only the related adverse events (AEs), ie, adverse drug reactions (ADRs), were documented.
Skin and subcutaneous tissue disorders DERMATITIS ALLERGIC	1.1% 1/93 • Number of events 1 • Adverse Events were collected over the whole study from Visit 1 (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro). Since this was a NIS with no safety objectives, only the related adverse events (AEs), ie, adverse drug reactions (ADRs), were documented.
Vascular disorders HYPERTENSION	1.1% 1/93 • Number of events 1 • Adverse Events were collected over the whole study from Visit 1 (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro). Since this was a NIS with no safety objectives, only the related adverse events (AEs), ie, adverse drug reactions (ADRs), were documented.

Additional Information

UCB Clinical Trial Call Center

UCB

Phone: +1 877 822 9493 (UCB)

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60