Parkinson's Disease
Conditions
Brief summary
The purpose of this survey is to evaluate the long-term safety of Rasagiline (AZILECT) in patients with Parkinson's disease in daily clinical practice and also collect efficacy information.
Detailed description
The drug being tested in this survey is called rasagiline tablet. This tablet is being tested to treat people with Parkinson's disease. This survey is an observational (non-interventional) study and will look at the long-term safety and efficacy of the rasagiline tablet in the routine clinical setting. The planned number of observed patients will be approximately 1000. This multi-center observational trial will be conducted in Japan.
Interventions
DRUGRasagiline
Rasagiline Tablets
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
-Patients with Parkinson's disease should be surveyed.
Exclusion criteria
-Participants who have contraindications on package insert of rasagiline.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Had One or More Adverse Events | 24 months | An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. |
| Number of Participants Who Had One or More Adverse Drug Reactions | 24 months | An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Unified Parkinson's Disease Rating Scale (UPDRS) | Baseline, Up to Month 24 (Final Assessment Point) | UPDRS retains the four-scale structure with a reorganization of the various subscales; (Part I) Mentation, behavior and mood (4 items), (Part II) Activities of daily living (13 items), (Part III) Motor (14 items), and (Part IV) Complications (11 items). Each item on Part III has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe, some items will be scored for 2 or more body parts. Total score range on Part III is 0-108, higher scores represent more severe symptom of Parkinson's disease (worse outcome). |
Countries
Japan
Participant flow
Recruitment details
Participants took part in the survey at 148 investigative sites in Japan, from 1 November 2018 to 31 October 2021.
Pre-assignment details
Participants with a historical diagnosis of Parkinson's disease were enrolled. Participants received rasagiline as part of a routine medical care.
Participants by arm
| Arm | Count |
|---|---|
| Rasagiline 1 mg Rasagiline 1 milligram (mg), orally, once daily for up to 24 months. Participants received interventions as part of routine medical care. | 961 |
| Total | 961 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 60 |
Baseline characteristics
| Characteristic | Rasagiline 1 mg | — |
|---|---|---|
| Age, Continuous | 72.5 Years STANDARD_DEVIATION 9.04 | — |
| Akinesia/Hypokinesia Score | 11.6 Scores on a Scale STANDARD_DEVIATION 6.6 | — |
| Dementia Had Dementia | 70 Participants | — |
| Dementia Had No Dementia | 891 Participants | — |
| Duration of Diagnosis of Parkinson's Disease | 6.82 Years STANDARD_DEVIATION 5.405 | — |
| Dyskinesia Had Dyskinesia | 166 Participants | — |
| Dyskinesia Had No Dyskinesia | 699 Participants | — |
| Healthcare Category Inpatient | 65 Participants | — |
| Healthcare Category Outpatient | 896 Participants | — |
| Height | 157.9 Centimeters (cm) STANDARD_DEVIATION 9.86 | — |
| Levodopa Use at Initiation of Treatment with the Study Drug Not Used | 96 Participants | — |
| Levodopa Use at Initiation of Treatment with the Study Drug Used | 865 Participants | — |
| Medical Complications Had Medical Complications | 759 Participants | — |
| Medical Complications Had No Medical Complications | 202 Participants | — |
| Modified Hoehn & Yahr Stage Stage 0 | 1 Participants | — |
| Modified Hoehn & Yahr Stage Stage 1 | 36 Participants | — |
| Modified Hoehn & Yahr Stage Stage 1.5 | 21 Participants | — |
| Modified Hoehn & Yahr Stage Stage 2 | 200 Participants | — |
| Modified Hoehn & Yahr Stage Stage 2.5 | 78 Participants | — |
| Modified Hoehn & Yahr Stage Stage 3 | 455 Participants | — |
| Modified Hoehn & Yahr Stage Stage 4 | 150 Participants | — |
| Modified Hoehn & Yahr Stage Stage 5 | 20 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Japan | 961 Participants | — |
| Rigidity Score | 5.9 Scores on a Scale STANDARD_DEVIATION 3.47 | — |
| Sex: Female, Male Female | 517 Participants | — |
| Sex: Female, Male Male | 444 Participants | — |
| Smoking Classification Current Smoker | 19 Participants | — |
| Smoking Classification Ex-Smoker | 122 Participants | — |
| Smoking Classification Never Smoked | 567 Participants | — |
| Smoking Classification Unknown | 253 Participants | — |
| Tremor Score | 3.0 Scores on a Scale STANDARD_DEVIATION 3.56 | — |
| Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score | 28.5 Scores on a Scale STANDARD_DEVIATION 14.36 | — |
| Wearing-off Phenomenon Had No Wearing-off Phenomenon | 394 Participants | — |
| Wearing-off Phenomenon Had Wearing-off Phenomenon | 471 Participants | — |
| Weight | 54.84 Kilograms (kg) STANDARD_DEVIATION 11.463 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 11 / 961 |
| other Total, other adverse events | 136 / 961 |
| serious Total, serious adverse events | 121 / 961 |
Outcome results
Primary
Number of Participants Who Had One or More Adverse Drug Reactions
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug.
Time frame: 24 months
Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rasagiline 1 mg | Number of Participants Who Had One or More Adverse Drug Reactions | 189 Participants |
Primary
Number of Participants Who Had One or More Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Time frame: 24 months
Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rasagiline 1 mg | Number of Participants Who Had One or More Adverse Events | 304 Participants |
Secondary
Change From Baseline in the Unified Parkinson's Disease Rating Scale (UPDRS)
UPDRS retains the four-scale structure with a reorganization of the various subscales; (Part I) Mentation, behavior and mood (4 items), (Part II) Activities of daily living (13 items), (Part III) Motor (14 items), and (Part IV) Complications (11 items). Each item on Part III has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe, some items will be scored for 2 or more body parts. Total score range on Part III is 0-108, higher scores represent more severe symptom of Parkinson's disease (worse outcome).
Time frame: Baseline, Up to Month 24 (Final Assessment Point)
Population: Efficacy assessment population, The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rasagiline 1 mg | Change From Baseline in the Unified Parkinson's Disease Rating Scale (UPDRS) | -2.7 Scores on a scale | Standard Deviation 9.46 |