Trial Outcomes & Findings for Change in Gastrointestinal Complaints After Switch From Oral Parkinson's Disease Treatment to Neupro® Transdermal Patch (NCT NCT01159691)

Last Updated: 2013-05-21

Results Overview

Patients were asked to classify the intensity of their GI complaints on a scale ranging from 0 (no complaints) to 100 (extremely severe complaints). Negative values indicate an improvement from Baseline to Visit 3 with larger negative values showing a better improvement.

Recruitment status

COMPLETED

Target enrollment

76 participants

Primary outcome timeframe

From Baseline to Visit 3 (approximately 6 weeks)

Results posted on

2013-05-21

Participant Flow

This study started to enroll subjects in June 2010 in order to end up with 21 centers in Germany.

76 patients were included in the Enrolled Set (ES), 75 of whom were treated with Neupro® at least once during the Observational Period and, thus, constituted the Safety Set (SS). The Full Analysis Set (FAS) encompassed all 65 patients who had been treated with Neupro® at least once and who had valid Baseline and Follow-up Visit values.

Participant milestones

Participant milestones
Measure	Neupro Routine treatment as per approved label in Europe/ in accordance with the terms of the local marketing authorization for Neupro® transdermal patch.
Overall Study STARTED	76
Overall Study COMPLETED	54
Overall Study NOT COMPLETED	22

Reasons for withdrawal

Reasons for withdrawal
Measure	Neupro Routine treatment as per approved label in Europe/ in accordance with the terms of the local marketing authorization for Neupro® transdermal patch.
Overall Study Lost to Follow-up	2
Overall Study Unknown reasons	1
Overall Study Discontinued Neupro due to Adverse Event	6
Overall Study Discontinued Neupro due to other reasons	1
Overall Study Disc. Neupro other & lost to follow-up	2
Overall Study Disc. Neupro other & unknown reasons	7
Overall Study Disc. Neupro due to AE & unknown reasons	2
Overall Study Disc. Neupro lack of efficacy & unknown	1

Baseline Characteristics

Change in Gastrointestinal Complaints After Switch From Oral Parkinson's Disease Treatment to Neupro® Transdermal Patch

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Neupro n=76 Participants Routine treatment as per approved label in Europe/ in accordance with the terms of the local marketing authorization for Neupro® transdermal patch.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants
Age, Categorical >=65 years	62 Participants n=5 Participants
Age Continuous	70.3 years STANDARD_DEVIATION 9.8 • n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants
Sex: Female, Male Male	45 Participants n=5 Participants
Region of Enrollment Germany	76 participants n=5 Participants
Weight	78.1 kilogram (kg) STANDARD_DEVIATION 12.9 • n=5 Participants
Height	171.1 centimeter (cm) STANDARD_DEVIATION 9.6 • n=5 Participants

PRIMARY outcome

Timeframe: From Baseline to Visit 3 (approximately 6 weeks)

Population: Of the 65 subjects in the Full Analysis Set, 58 are included in this analysis.

Outcome measures

Outcome measures
Measure	Neupro n=58 Participants Routine treatment as per approved label in Europe/ in accordance with the terms of the local marketing authorization for Neupro® transdermal patch.
Change From Baseline to Visit 3 in the Assessment of Intensity of Gastrointestinal (GI) Complaints for Any Reason as Per Visual Analogue Scale (VAS)	-26.8 millimeter (mm) Standard Deviation 28.8

PRIMARY outcome

Timeframe: From Baseline to Visit 3 (approximately 6 weeks)

Population: Of the 65 subjects in the Full Analysis Set, 58 are included in this analysis.

Sum score of GI complaints was calculated from frequency and intensity of the complaints. The intensity of GI complaints during the last week ranges from 0 (no complaints) to 3 (severe) and the frequency of these complaints during the last week ranges from 0 (never) to 4 (every day). For each of the seven GI complaints assessed at a visit (swallowing disorders, heartburn, feeling of fullness, nausea, vomiting, abdominal pain, and diarrhea), intensity and frequency were multiplied to achieve individual item scores of GI complaints (range: 0 - 12). Finally, the sum score of GI complaints per visit was calculated by accumulating 6 of the 7 item scores (excluding swallowing disorders, which was recorded at Baseline only) for patients with valid values in each score (range: 0 - 72). Negative values indicate an improvement from Baseline to Visit 3 with larger negative values showing a better improvement.

Outcome measures

Outcome measures
Measure	Neupro n=58 Participants Routine treatment as per approved label in Europe/ in accordance with the terms of the local marketing authorization for Neupro® transdermal patch.
Change From Baseline to Visit 3 in the Sum Score of Gastrointestinal (GI) Complaints	-8.4 units on a scale Standard Deviation 8.1

PRIMARY outcome

Timeframe: At Visit 2 (after approximately 2-4 weeks)

Population: All of the 65 subjects in the Full Analysis Set are included in this analysis.

Patient satisfaction referring to GI complaints is classified into 5 categories: * Missing * Very satisfied * Satisfied * Moderately satisfied * Not satisfied.

Outcome measures

Outcome measures
Measure	Neupro n=65 Participants Routine treatment as per approved label in Europe/ in accordance with the terms of the local marketing authorization for Neupro® transdermal patch.
Assessment of Patient Satisfaction Referring to Gastrointestinal (GI) Complaints Following Treatment Switch to Neupro® at Visit 2 Missing	1 participants
Assessment of Patient Satisfaction Referring to Gastrointestinal (GI) Complaints Following Treatment Switch to Neupro® at Visit 2 Very satisfied	25 participants
Assessment of Patient Satisfaction Referring to Gastrointestinal (GI) Complaints Following Treatment Switch to Neupro® at Visit 2 Satisfied	26 participants
Assessment of Patient Satisfaction Referring to Gastrointestinal (GI) Complaints Following Treatment Switch to Neupro® at Visit 2 Moderately satisfied	8 participants
Assessment of Patient Satisfaction Referring to Gastrointestinal (GI) Complaints Following Treatment Switch to Neupro® at Visit 2 Not satisfied	5 participants

PRIMARY outcome

Timeframe: At Visit 3 (after approximately 6 weeks)

Population: All of the 65 subjects in the Full Analysis Set are included in this analysis.

Patient satisfaction referring to GI complaints is classified into 5 categories: * Missing * Very satisfied * Satisfied * Moderately satisfied * Not satisfied.

Outcome measures

Outcome measures
Measure	Neupro n=65 Participants Routine treatment as per approved label in Europe/ in accordance with the terms of the local marketing authorization for Neupro® transdermal patch.
Assessment of Patient Satisfaction Referring to Gastrointestinal (GI) Complaints Following Treatment Switch to Neupro® at Visit 3 Missing	7 participants
Assessment of Patient Satisfaction Referring to Gastrointestinal (GI) Complaints Following Treatment Switch to Neupro® at Visit 3 Very satisfied	28 participants
Assessment of Patient Satisfaction Referring to Gastrointestinal (GI) Complaints Following Treatment Switch to Neupro® at Visit 3 Satisfied	22 participants
Assessment of Patient Satisfaction Referring to Gastrointestinal (GI) Complaints Following Treatment Switch to Neupro® at Visit 3 Moderately satisfied	6 participants
Assessment of Patient Satisfaction Referring to Gastrointestinal (GI) Complaints Following Treatment Switch to Neupro® at Visit 3 Not satisfied	2 participants

Adverse Events

Neupro

Serious events: 4 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Neupro n=75 participants at risk Routine treatment as per approved label in Europe/ in accordance with the terms of the local marketing authorization for Neupro® transdermal patch.
General disorders Death	1.3% 1/75 • Number of events 1 • Adverse Events (AEs) were collected over the entire Study Period from Baseline (Visit 1) up to approximately 6 weeks (Visit 3). Adverse Events refer to the Safety Set. The Safety Set encompasses all included patients who were treated with Neupro® at least once. Of the 76 patients in the Enrolled Set, 75 patients are included in the Safety Set.
Injury, poisoning and procedural complications Lumbar vertebral fracture	2.7% 2/75 • Number of events 2 • Adverse Events (AEs) were collected over the entire Study Period from Baseline (Visit 1) up to approximately 6 weeks (Visit 3). Adverse Events refer to the Safety Set. The Safety Set encompasses all included patients who were treated with Neupro® at least once. Of the 76 patients in the Enrolled Set, 75 patients are included in the Safety Set.
Surgical and medical procedures Haematoma evacuation	1.3% 1/75 • Number of events 1 • Adverse Events (AEs) were collected over the entire Study Period from Baseline (Visit 1) up to approximately 6 weeks (Visit 3). Adverse Events refer to the Safety Set. The Safety Set encompasses all included patients who were treated with Neupro® at least once. Of the 76 patients in the Enrolled Set, 75 patients are included in the Safety Set.

Other adverse events

Other adverse events
Measure	Neupro n=75 participants at risk Routine treatment as per approved label in Europe/ in accordance with the terms of the local marketing authorization for Neupro® transdermal patch.
Eye disorders Lacrimation increased	1.3% 1/75 • Number of events 1 • Adverse Events (AEs) were collected over the entire Study Period from Baseline (Visit 1) up to approximately 6 weeks (Visit 3). Adverse Events refer to the Safety Set. The Safety Set encompasses all included patients who were treated with Neupro® at least once. Of the 76 patients in the Enrolled Set, 75 patients are included in the Safety Set.
Gastrointestinal disorders Dyspepsia	1.3% 1/75 • Number of events 1 • Adverse Events (AEs) were collected over the entire Study Period from Baseline (Visit 1) up to approximately 6 weeks (Visit 3). Adverse Events refer to the Safety Set. The Safety Set encompasses all included patients who were treated with Neupro® at least once. Of the 76 patients in the Enrolled Set, 75 patients are included in the Safety Set.
General disorders Application site erythema	1.3% 1/75 • Number of events 1 • Adverse Events (AEs) were collected over the entire Study Period from Baseline (Visit 1) up to approximately 6 weeks (Visit 3). Adverse Events refer to the Safety Set. The Safety Set encompasses all included patients who were treated with Neupro® at least once. Of the 76 patients in the Enrolled Set, 75 patients are included in the Safety Set.
General disorders Fatigue	1.3% 1/75 • Number of events 1 • Adverse Events (AEs) were collected over the entire Study Period from Baseline (Visit 1) up to approximately 6 weeks (Visit 3). Adverse Events refer to the Safety Set. The Safety Set encompasses all included patients who were treated with Neupro® at least once. Of the 76 patients in the Enrolled Set, 75 patients are included in the Safety Set.
General disorders Chest discomfort	1.3% 1/75 • Number of events 1 • Adverse Events (AEs) were collected over the entire Study Period from Baseline (Visit 1) up to approximately 6 weeks (Visit 3). Adverse Events refer to the Safety Set. The Safety Set encompasses all included patients who were treated with Neupro® at least once. Of the 76 patients in the Enrolled Set, 75 patients are included in the Safety Set.
General disorders Oedema peripheral	1.3% 1/75 • Number of events 1 • Adverse Events (AEs) were collected over the entire Study Period from Baseline (Visit 1) up to approximately 6 weeks (Visit 3). Adverse Events refer to the Safety Set. The Safety Set encompasses all included patients who were treated with Neupro® at least once. Of the 76 patients in the Enrolled Set, 75 patients are included in the Safety Set.
General disorders Pain	1.3% 1/75 • Number of events 1 • Adverse Events (AEs) were collected over the entire Study Period from Baseline (Visit 1) up to approximately 6 weeks (Visit 3). Adverse Events refer to the Safety Set. The Safety Set encompasses all included patients who were treated with Neupro® at least once. Of the 76 patients in the Enrolled Set, 75 patients are included in the Safety Set.
General disorders Drug ineffective	1.3% 1/75 • Number of events 1 • Adverse Events (AEs) were collected over the entire Study Period from Baseline (Visit 1) up to approximately 6 weeks (Visit 3). Adverse Events refer to the Safety Set. The Safety Set encompasses all included patients who were treated with Neupro® at least once. Of the 76 patients in the Enrolled Set, 75 patients are included in the Safety Set.
Investigations Hepatic enzyme increased	1.3% 1/75 • Number of events 1 • Adverse Events (AEs) were collected over the entire Study Period from Baseline (Visit 1) up to approximately 6 weeks (Visit 3). Adverse Events refer to the Safety Set. The Safety Set encompasses all included patients who were treated with Neupro® at least once. Of the 76 patients in the Enrolled Set, 75 patients are included in the Safety Set.
Musculoskeletal and connective tissue disorders Muscle spasms	1.3% 1/75 • Number of events 1 • Adverse Events (AEs) were collected over the entire Study Period from Baseline (Visit 1) up to approximately 6 weeks (Visit 3). Adverse Events refer to the Safety Set. The Safety Set encompasses all included patients who were treated with Neupro® at least once. Of the 76 patients in the Enrolled Set, 75 patients are included in the Safety Set.
Nervous system disorders Somnolence	1.3% 1/75 • Number of events 1 • Adverse Events (AEs) were collected over the entire Study Period from Baseline (Visit 1) up to approximately 6 weeks (Visit 3). Adverse Events refer to the Safety Set. The Safety Set encompasses all included patients who were treated with Neupro® at least once. Of the 76 patients in the Enrolled Set, 75 patients are included in the Safety Set.
Nervous system disorders Restless legs syndrome	1.3% 1/75 • Number of events 1 • Adverse Events (AEs) were collected over the entire Study Period from Baseline (Visit 1) up to approximately 6 weeks (Visit 3). Adverse Events refer to the Safety Set. The Safety Set encompasses all included patients who were treated with Neupro® at least once. Of the 76 patients in the Enrolled Set, 75 patients are included in the Safety Set.
Nervous system disorders Dizziness	1.3% 1/75 • Number of events 1 • Adverse Events (AEs) were collected over the entire Study Period from Baseline (Visit 1) up to approximately 6 weeks (Visit 3). Adverse Events refer to the Safety Set. The Safety Set encompasses all included patients who were treated with Neupro® at least once. Of the 76 patients in the Enrolled Set, 75 patients are included in the Safety Set.
Nervous system disorders Paraesthesia	1.3% 1/75 • Number of events 1 • Adverse Events (AEs) were collected over the entire Study Period from Baseline (Visit 1) up to approximately 6 weeks (Visit 3). Adverse Events refer to the Safety Set. The Safety Set encompasses all included patients who were treated with Neupro® at least once. Of the 76 patients in the Enrolled Set, 75 patients are included in the Safety Set.
Nervous system disorders On and off phenomenon	1.3% 1/75 • Number of events 1 • Adverse Events (AEs) were collected over the entire Study Period from Baseline (Visit 1) up to approximately 6 weeks (Visit 3). Adverse Events refer to the Safety Set. The Safety Set encompasses all included patients who were treated with Neupro® at least once. Of the 76 patients in the Enrolled Set, 75 patients are included in the Safety Set.
Nervous system disorders Dysgeusia	1.3% 1/75 • Number of events 1 • Adverse Events (AEs) were collected over the entire Study Period from Baseline (Visit 1) up to approximately 6 weeks (Visit 3). Adverse Events refer to the Safety Set. The Safety Set encompasses all included patients who were treated with Neupro® at least once. Of the 76 patients in the Enrolled Set, 75 patients are included in the Safety Set.
Nervous system disorders Tremor	1.3% 1/75 • Number of events 1 • Adverse Events (AEs) were collected over the entire Study Period from Baseline (Visit 1) up to approximately 6 weeks (Visit 3). Adverse Events refer to the Safety Set. The Safety Set encompasses all included patients who were treated with Neupro® at least once. Of the 76 patients in the Enrolled Set, 75 patients are included in the Safety Set.
Psychiatric disorders Hallucination	1.3% 1/75 • Number of events 1 • Adverse Events (AEs) were collected over the entire Study Period from Baseline (Visit 1) up to approximately 6 weeks (Visit 3). Adverse Events refer to the Safety Set. The Safety Set encompasses all included patients who were treated with Neupro® at least once. Of the 76 patients in the Enrolled Set, 75 patients are included in the Safety Set.
Psychiatric disorders Sleep disorder	2.7% 2/75 • Number of events 2 • Adverse Events (AEs) were collected over the entire Study Period from Baseline (Visit 1) up to approximately 6 weeks (Visit 3). Adverse Events refer to the Safety Set. The Safety Set encompasses all included patients who were treated with Neupro® at least once. Of the 76 patients in the Enrolled Set, 75 patients are included in the Safety Set.
Skin and subcutaneous tissue disorders Blister	1.3% 1/75 • Number of events 1 • Adverse Events (AEs) were collected over the entire Study Period from Baseline (Visit 1) up to approximately 6 weeks (Visit 3). Adverse Events refer to the Safety Set. The Safety Set encompasses all included patients who were treated with Neupro® at least once. Of the 76 patients in the Enrolled Set, 75 patients are included in the Safety Set.
Skin and subcutaneous tissue disorders Swelling face	1.3% 1/75 • Number of events 1 • Adverse Events (AEs) were collected over the entire Study Period from Baseline (Visit 1) up to approximately 6 weeks (Visit 3). Adverse Events refer to the Safety Set. The Safety Set encompasses all included patients who were treated with Neupro® at least once. Of the 76 patients in the Enrolled Set, 75 patients are included in the Safety Set.
Skin and subcutaneous tissue disorders Dermatitis contact	2.7% 2/75 • Number of events 2 • Adverse Events (AEs) were collected over the entire Study Period from Baseline (Visit 1) up to approximately 6 weeks (Visit 3). Adverse Events refer to the Safety Set. The Safety Set encompasses all included patients who were treated with Neupro® at least once. Of the 76 patients in the Enrolled Set, 75 patients are included in the Safety Set.
Skin and subcutaneous tissue disorders Skin irritation	2.7% 2/75 • Number of events 2 • Adverse Events (AEs) were collected over the entire Study Period from Baseline (Visit 1) up to approximately 6 weeks (Visit 3). Adverse Events refer to the Safety Set. The Safety Set encompasses all included patients who were treated with Neupro® at least once. Of the 76 patients in the Enrolled Set, 75 patients are included in the Safety Set.
Skin and subcutaneous tissue disorders Eczema	1.3% 1/75 • Number of events 1 • Adverse Events (AEs) were collected over the entire Study Period from Baseline (Visit 1) up to approximately 6 weeks (Visit 3). Adverse Events refer to the Safety Set. The Safety Set encompasses all included patients who were treated with Neupro® at least once. Of the 76 patients in the Enrolled Set, 75 patients are included in the Safety Set.
Skin and subcutaneous tissue disorders Erythema	2.7% 2/75 • Number of events 2 • Adverse Events (AEs) were collected over the entire Study Period from Baseline (Visit 1) up to approximately 6 weeks (Visit 3). Adverse Events refer to the Safety Set. The Safety Set encompasses all included patients who were treated with Neupro® at least once. Of the 76 patients in the Enrolled Set, 75 patients are included in the Safety Set.
Skin and subcutaneous tissue disorders Pruritus	4.0% 3/75 • Number of events 3 • Adverse Events (AEs) were collected over the entire Study Period from Baseline (Visit 1) up to approximately 6 weeks (Visit 3). Adverse Events refer to the Safety Set. The Safety Set encompasses all included patients who were treated with Neupro® at least once. Of the 76 patients in the Enrolled Set, 75 patients are included in the Safety Set.
Skin and subcutaneous tissue disorders Rash macular	1.3% 1/75 • Number of events 1 • Adverse Events (AEs) were collected over the entire Study Period from Baseline (Visit 1) up to approximately 6 weeks (Visit 3). Adverse Events refer to the Safety Set. The Safety Set encompasses all included patients who were treated with Neupro® at least once. Of the 76 patients in the Enrolled Set, 75 patients are included in the Safety Set.

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