Parkinson Disease
Conditions
Brief summary
The objective of this PMS study is the evaluation of depressive symptoms measured with Unified Parkinson's Disease Rating Scale (UPDRS) Part I (mentation, behavior and mood) and with Hospital Anxiety and Depression Scale Depression Subscore (HADS-D) under pramipexole treatment in early and advanced PD patients. In addition it will be investigated whether improvement of depressive symptoms is linked to improvement in motor function (UPDRS Part III). 250 patients diagnosed with Parkinson's disease (PD) will be investigated by 80 specialists (neurologists or neurologists/psychiatrists) across Austria. Pramipexole will be taken orally at an initial dosage of 0.375 mg/day (using a three times daily schedule independently of food intake) and can be titrated upwards, as required, at weekly intervals to a maximum total daily dose of 4,5 mg (TID) as per Summary of Product Characteristics (SPC).
Interventions
Sponsors
Boehringer Ingelheim
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Idiopathic PD with or without fluctuations * Indication for treatment with Pramipexole * Presence of at least mild depressive symptoms (as judged by the treating physician) * Ability to reliably complete a self-rating scale (Hospital Anxiety and Depression Scale (HADS))
Exclusion criteria
* Any contraindications according to the Summary of Product Characteristics (SPC), hypersensitivity to pramipexole or to any of the excipients * Ongoing treatment with pramipexole
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in UPDRS Part III (Motor Examination) | Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score) | 14 components rating scale with 27 items scored by 0 (none) - 4 (severe) |
| Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I (Mentation, Behaviour and Mood) | Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score) | Rating scale scored from 0 (none) - 4 (severe). The UPDRS Part I (Mentation, Behaviour and Mood during the Past Week) consist of 4 items, each of them is scored from 0 (normal) to 4 (severe). Reduction in this score over time is interpreted as improvement. Total UPDRS part I score ranges from 0 = best score to 16 = worst score |
| Change From Baseline in Hospital Anxiety and Depression Scale - HADS-D Depression Subscore | Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score) | Depression Scale - 7 items scored for each individual question from 0 = best and 3 = worst. HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 14 items, thereof seven statements describe anxiety and seven statements depression. Each answer is rated on a four-point scale (0-3). All seven answers are summarized and calculated to a total score to the anxiety scale and to the depression scale with a maximum score of 21 points for each scale. |
| Change From Baseline in Hospital Anxiety and Depression Scale - HADS-A Anxiety Subscore | Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score) | Anxiety Scale - 7 items scored for each individual question from 0 = best and 3 = worst. HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 14 items, thereof seven statements describe anxiety and seven statements depression. Each answer is rated on a four-point scale (0-3). All seven answers are summarized and calculated to a total score to the anxiety scale and to the depression scale with a maximum score of 21 points for each scale. |
Countries
Austria
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Early PD Early Parkinson's Disease (PD) patients | 189 |
| Advanced PD Advanced Parkinson's Disease (PD) patients | 97 |
| Total | 286 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Efficacy insufficient + patients wish | 0 | 1 |
| Overall Study | Lack of Efficacy | 1 | 0 |
| Overall Study | Lost to Follow-up | 3 | 1 |
| Overall Study | missing | 1 | 0 |
| Overall Study | Other reasons | 4 | 2 |
| Overall Study | Tolerability insufficient | 5 | 2 |
| Overall Study | Tolerability insufficient +Patients wish | 0 | 1 |
| Overall Study | Withdrawal by Subject | 6 | 3 |
Baseline characteristics
| Characteristic | Early PD | Advanced PD | Total |
|---|---|---|---|
| Age, Continuous | 69.1 years STANDARD_DEVIATION 9.44 | 73.8 years STANDARD_DEVIATION 6.97 | 70.6 years STANDARD_DEVIATION 8.96 |
| Sex/Gender, Customized Female | 80 participants | 35 participants | 115 participants |
| Sex/Gender, Customized Male | 108 participants | 61 participants | 169 participants |
| Sex/Gender, Customized missing | 1 participants | 1 participants | 2 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 189 | 0 / 97 |
| serious Total, serious adverse events | 0 / 189 | 1 / 97 |
Outcome results
Primary
Change From Baseline in Hospital Anxiety and Depression Scale - HADS-A Anxiety Subscore
Anxiety Scale - 7 items scored for each individual question from 0 = best and 3 = worst. HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 14 items, thereof seven statements describe anxiety and seven statements depression. Each answer is rated on a four-point scale (0-3). All seven answers are summarized and calculated to a total score to the anxiety scale and to the depression scale with a maximum score of 21 points for each scale.
Time frame: Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score)
Population: Only those patients of the full analysis set (FAS) with an evaluation of HADS-A at visit 3 were included in this analysis
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Early PD | Change From Baseline in Hospital Anxiety and Depression Scale - HADS-A Anxiety Subscore | 2 Points on a scale |
| Advanced PD | Change From Baseline in Hospital Anxiety and Depression Scale - HADS-A Anxiety Subscore | 4 Points on a scale |
Primary
Change From Baseline in Hospital Anxiety and Depression Scale - HADS-D Depression Subscore
Depression Scale - 7 items scored for each individual question from 0 = best and 3 = worst. HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 14 items, thereof seven statements describe anxiety and seven statements depression. Each answer is rated on a four-point scale (0-3). All seven answers are summarized and calculated to a total score to the anxiety scale and to the depression scale with a maximum score of 21 points for each scale.
Time frame: Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score)
Population: Only those patients of the full analysis set (FAS) with an evaluation of HADS-D at visit 3 were included in this analysis
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Early PD | Change From Baseline in Hospital Anxiety and Depression Scale - HADS-D Depression Subscore | 3 Points on a scale |
| Advanced PD | Change From Baseline in Hospital Anxiety and Depression Scale - HADS-D Depression Subscore | 4 Points on a scale |
Primary
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I (Mentation, Behaviour and Mood)
Rating scale scored from 0 (none) - 4 (severe). The UPDRS Part I (Mentation, Behaviour and Mood during the Past Week) consist of 4 items, each of them is scored from 0 (normal) to 4 (severe). Reduction in this score over time is interpreted as improvement. Total UPDRS part I score ranges from 0 = best score to 16 = worst score
Time frame: Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score)
Population: Only those patients of the full analysis set (FAS) with an evaluation of UPDRS Part I at visit 3 were included in this analysis
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Early PD | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I (Mentation, Behaviour and Mood) | 2 Points on a scale |
| Advanced PD | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I (Mentation, Behaviour and Mood) | 2 Points on a scale |
Primary
Change From Baseline in UPDRS Part III (Motor Examination)
14 components rating scale with 27 items scored by 0 (none) - 4 (severe)
Time frame: Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score)
Population: Only those patients of the full analysis set (FAS) with an evaluation of UPDRS Part III at visit 3 were included in this analysis
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Early PD | Change From Baseline in UPDRS Part III (Motor Examination) | 9 Points on a scale |
| Advanced PD | Change From Baseline in UPDRS Part III (Motor Examination) | 10 Points on a scale |