Idiopathic Parkinson's Disease
Conditions
Keywords
Rotigotine, Neupro®, Parkinson's disease, Gastrointestinal, Switch from oral therapy to patch
Brief summary
The study intends to collect data on gastrointestinal symptoms (swallowing disorders, heartburn, feeling of fullness, nausea, vomiting, abdominal pain, diarrhea) and on patient satisfaction under everyday practice conditions after changing treatment to Neupro® transdermal patch in patients suffering from idiopathic Parkinson´s Disease with gastrointestinal symptoms while being treated with oral antiparkinson drugs. The objective of the study is to ascertain whether switching therapy to Neupro® transdermal patch can provide any relief in gastrointestinal symptoms.
Detailed description
Routine treatment as per approved label in Europe in accordance with the terms of the local marketing authorization for Neupro®.
Interventions
None listed
Sponsors
UCB Pharma GmbH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* The decision to prescribe Neupro® must have been made by the physician before and independently of his/her decision to include the patient in the study * The patient's treatment must be in accordance with the terms of the local marketing authorization (MA) for Neupro® * The patient must have a diagnosis of Idiopathic Parkinson's disease * The patient must have signed the Consent form regarding study information, data transfer and use * Patient suffering from gastrointestinal symptoms while being treated with oral Parkinson's medication
Exclusion criteria
Not applicable
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Visit 3 in the Assessment of Intensity of Gastrointestinal (GI) Complaints for Any Reason as Per Visual Analogue Scale (VAS) | From Baseline to Visit 3 (approximately 6 weeks) | 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. |
| Change From Baseline to Visit 3 in the Sum Score of Gastrointestinal (GI) Complaints | From Baseline to Visit 3 (approximately 6 weeks) | 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. |
| Assessment of Patient Satisfaction Referring to Gastrointestinal (GI) Complaints Following Treatment Switch to Neupro® at Visit 2 | At Visit 2 (after approximately 2-4 weeks) | Patient satisfaction referring to GI complaints is classified into 5 categories: * Missing * Very satisfied * Satisfied * Moderately satisfied * Not satisfied. |
| Assessment of Patient Satisfaction Referring to Gastrointestinal (GI) Complaints Following Treatment Switch to Neupro® at Visit 3 | At Visit 3 (after approximately 6 weeks) | Patient satisfaction referring to GI complaints is classified into 5 categories: * Missing * Very satisfied * Satisfied * Moderately satisfied * Not satisfied. |
Countries
Germany
Participant flow
Recruitment details
This study started to enroll subjects in June 2010 in order to end up with 21 centers in Germany.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Neupro Routine treatment as per approved label in Europe/ in accordance with the terms of the local marketing authorization for Neupro® transdermal patch. | 76 |
| Total | 76 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Disc. Neupro due to AE & unknown reasons | 2 |
| Overall Study | Disc. Neupro lack of efficacy & unknown | 1 |
| Overall Study | Disc. Neupro other & lost to follow-up | 2 |
| Overall Study | Disc. Neupro other & unknown reasons | 7 |
| Overall Study | Discontinued Neupro due to Adverse Event | 6 |
| Overall Study | Discontinued Neupro due to other reasons | 1 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Unknown reasons | 1 |
Baseline characteristics
| Characteristic | Neupro |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 62 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Age Continuous | 70.3 years STANDARD_DEVIATION 9.8 |
| Height | 171.1 centimeter (cm) STANDARD_DEVIATION 9.6 |
| Region of Enrollment Germany | 76 participants |
| Sex: Female, Male Female | 31 Participants |
| Sex: Female, Male Male | 45 Participants |
| Weight | 78.1 kilogram (kg) STANDARD_DEVIATION 12.9 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 21 / 75 |
| serious Total, serious adverse events | 4 / 75 |
Outcome results
Primary
Assessment of Patient Satisfaction Referring to Gastrointestinal (GI) Complaints Following Treatment Switch to Neupro® at Visit 2
Patient satisfaction referring to GI complaints is classified into 5 categories: * Missing * Very satisfied * Satisfied * Moderately satisfied * Not satisfied.
Time frame: At Visit 2 (after approximately 2-4 weeks)
Population: All of the 65 subjects in the Full Analysis Set are included in this analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Neupro | Assessment of Patient Satisfaction Referring to Gastrointestinal (GI) Complaints Following Treatment Switch to Neupro® at Visit 2 | Missing | 1 participants |
| Neupro | Assessment of Patient Satisfaction Referring to Gastrointestinal (GI) Complaints Following Treatment Switch to Neupro® at Visit 2 | Very satisfied | 25 participants |
| Neupro | Assessment of Patient Satisfaction Referring to Gastrointestinal (GI) Complaints Following Treatment Switch to Neupro® at Visit 2 | Satisfied | 26 participants |
| Neupro | Assessment of Patient Satisfaction Referring to Gastrointestinal (GI) Complaints Following Treatment Switch to Neupro® at Visit 2 | Moderately satisfied | 8 participants |
| Neupro | Assessment of Patient Satisfaction Referring to Gastrointestinal (GI) Complaints Following Treatment Switch to Neupro® at Visit 2 | Not satisfied | 5 participants |
Primary
Assessment of Patient Satisfaction Referring to Gastrointestinal (GI) Complaints Following Treatment Switch to Neupro® at Visit 3
Patient satisfaction referring to GI complaints is classified into 5 categories: * Missing * Very satisfied * Satisfied * Moderately satisfied * Not satisfied.
Time frame: At Visit 3 (after approximately 6 weeks)
Population: All of the 65 subjects in the Full Analysis Set are included in this analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Neupro | Assessment of Patient Satisfaction Referring to Gastrointestinal (GI) Complaints Following Treatment Switch to Neupro® at Visit 3 | Missing | 7 participants |
| Neupro | Assessment of Patient Satisfaction Referring to Gastrointestinal (GI) Complaints Following Treatment Switch to Neupro® at Visit 3 | Very satisfied | 28 participants |
| Neupro | Assessment of Patient Satisfaction Referring to Gastrointestinal (GI) Complaints Following Treatment Switch to Neupro® at Visit 3 | Satisfied | 22 participants |
| Neupro | Assessment of Patient Satisfaction Referring to Gastrointestinal (GI) Complaints Following Treatment Switch to Neupro® at Visit 3 | Moderately satisfied | 6 participants |
| Neupro | Assessment of Patient Satisfaction Referring to Gastrointestinal (GI) Complaints Following Treatment Switch to Neupro® at Visit 3 | Not satisfied | 2 participants |
Primary
Change From Baseline to Visit 3 in the Assessment of Intensity of Gastrointestinal (GI) Complaints for Any Reason as Per Visual Analogue Scale (VAS)
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.
Time frame: From Baseline to Visit 3 (approximately 6 weeks)
Population: Of the 65 subjects in the Full Analysis Set, 58 are included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neupro | 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
Change From Baseline to Visit 3 in the Sum Score of Gastrointestinal (GI) Complaints
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.
Time frame: From Baseline to Visit 3 (approximately 6 weeks)
Population: Of the 65 subjects in the Full Analysis Set, 58 are included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neupro | Change From Baseline to Visit 3 in the Sum Score of Gastrointestinal (GI) Complaints | -8.4 units on a scale | Standard Deviation 8.1 |