Trial Outcomes & Findings for Clinical Outcome Assessment of Parkinson's Disease Patients Treated With XADAGO (Safinamide) (NCT NCT03944785)
NCT ID: NCT03944785
Last Updated: 2023-06-07
Results Overview
MDS-UPDRS: 4-part assessment of the multiple clinical disabilities of Parkinson's Disease. Part I (13 items; Score 0-52) examines non-motor experiences, Part II (13 items; Score 0-52) examines motor experiences, Part III (33 items; Score 0-132) examines the cardinal motor disabilities and Part IV (6 items; Score 0-24) examines motor complications. Each Part has 0-4 ratings, where 0 (no problems) to 4 (severe problems) and scores for each part are summed to calculate the total score which ranges from 0-260. Higher scores represent worse outcomes for each part and total score.
COMPLETED
164 participants
Baseline to Study Day 60
2023-06-07
Participant Flow
Participant milestones
| Measure |
DA Switchers
Parkinson's Disease patients that have switched to safinamide (XADAGO) from a dopamine agonist (DA)
|
MAO-B Switchers
Parkinson's Disease patients that have switched to safinamide (XADAGO) from a monoamine oxidase-B (MAO-B) inhibitor
|
MAO-B Naive
Parkinson's Disease patients taking safinamide (XADAGO) that are MAO-B inhibitor naïve.
|
|---|---|---|---|
|
2 Month Study Completion
STARTED
|
2
|
34
|
128
|
|
2 Month Study Completion
COMPLETED
|
2
|
30
|
123
|
|
2 Month Study Completion
NOT COMPLETED
|
0
|
4
|
5
|
|
4 Month Study Optional Extension
STARTED
|
1
|
10
|
64
|
|
4 Month Study Optional Extension
COMPLETED
|
0
|
8
|
41
|
|
4 Month Study Optional Extension
NOT COMPLETED
|
1
|
2
|
23
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluable Population: All patients in the safety population who complete at least the Movement Disorders Society - Unified Parkinson's Disease Rating Scale assessment at the Study Day 60 visit
Baseline characteristics by cohort
| Measure |
DA Switchers
n=2 Participants
Parkinson's Disease patients that have switched to safinamide (XADAGO) from a dopamine agonist (DA)
|
MAO-B
n=34 Participants
Parkinson's Disease patients that have switched to safinamide (XADAGO) from a monoamine oxidase-B (MAO-B) inhibitor
|
MAO-B Naive
n=128 Participants
Parkinson's Disease patients taking safinamide (XADAGO) that are MAO-B inhibitor naïve.
|
Total
n=164 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
62.5 years
STANDARD_DEVIATION 6.36 • n=2 Participants
|
65.3 years
STANDARD_DEVIATION 8.28 • n=34 Participants
|
68.1 years
STANDARD_DEVIATION 7.77 • n=128 Participants
|
67.4 years
STANDARD_DEVIATION 7.92 • n=164 Participants
|
|
Age, Customized
Age 30-65
|
1 Participants
n=2 Participants
|
16 Participants
n=34 Participants
|
39 Participants
n=128 Participants
|
56 Participants
n=164 Participants
|
|
Age, Customized
Age >= 65
|
1 Participants
n=2 Participants
|
18 Participants
n=34 Participants
|
89 Participants
n=128 Participants
|
108 Participants
n=164 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=2 Participants
|
6 Participants
n=34 Participants
|
43 Participants
n=128 Participants
|
49 Participants
n=164 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=2 Participants
|
28 Participants
n=34 Participants
|
85 Participants
n=128 Participants
|
115 Participants
n=164 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=2 Participants
|
0 Participants
n=34 Participants
|
6 Participants
n=128 Participants
|
6 Participants
n=164 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=2 Participants
|
34 Participants
n=34 Participants
|
122 Participants
n=128 Participants
|
158 Participants
n=164 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=2 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=128 Participants
|
0 Participants
n=164 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=2 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=128 Participants
|
0 Participants
n=164 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=2 Participants
|
3 Participants
n=34 Participants
|
4 Participants
n=128 Participants
|
7 Participants
n=164 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=2 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=128 Participants
|
0 Participants
n=164 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=2 Participants
|
1 Participants
n=34 Participants
|
1 Participants
n=128 Participants
|
2 Participants
n=164 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=2 Participants
|
30 Participants
n=34 Participants
|
121 Participants
n=128 Participants
|
153 Participants
n=164 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=2 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=128 Participants
|
0 Participants
n=164 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=2 Participants
|
0 Participants
n=34 Participants
|
2 Participants
n=128 Participants
|
2 Participants
n=164 Participants
|
|
Height (cm)
|
179.6 cm
STANDARD_DEVIATION 6.51 • n=2 Participants
|
173.1 cm
STANDARD_DEVIATION 11.67 • n=34 Participants
|
171.0 cm
STANDARD_DEVIATION 11.91 • n=128 Participants
|
171.6 cm
STANDARD_DEVIATION 11.83 • n=164 Participants
|
|
Weight (kg)
|
96.2 kg
STANDARD_DEVIATION 0.64 • n=2 Participants
|
85.0 kg
STANDARD_DEVIATION 16.95 • n=34 Participants
|
88.1 kg
STANDARD_DEVIATION 22.60 • n=128 Participants
|
87.6 kg
STANDARD_DEVIATION 21.42 • n=164 Participants
|
|
BMI (kg/m^2)
|
29.9 kg/m^2
STANDARD_DEVIATION 2.36 • n=2 Participants
|
28.4 kg/m^2
STANDARD_DEVIATION 5.17 • n=34 Participants
|
30.1 kg/m^2
STANDARD_DEVIATION 7.05 • n=128 Participants
|
29.7 kg/m^2
STANDARD_DEVIATION 6.68 • n=164 Participants
|
|
Movement Disorders Society - Unified Parkinson's Disease Rating Scale
Part 1
|
12.0 units on a scale
STANDARD_DEVIATION 2.83 • n=2 Participants • Evaluable Population: All patients in the safety population who complete at least the Movement Disorders Society - Unified Parkinson's Disease Rating Scale assessment at the Study Day 60 visit
|
10.5 units on a scale
STANDARD_DEVIATION 6.32 • n=28 Participants • Evaluable Population: All patients in the safety population who complete at least the Movement Disorders Society - Unified Parkinson's Disease Rating Scale assessment at the Study Day 60 visit
|
12.3 units on a scale
STANDARD_DEVIATION 6.88 • n=123 Participants • Evaluable Population: All patients in the safety population who complete at least the Movement Disorders Society - Unified Parkinson's Disease Rating Scale assessment at the Study Day 60 visit
|
11.9 units on a scale
STANDARD_DEVIATION 6.75 • n=153 Participants • Evaluable Population: All patients in the safety population who complete at least the Movement Disorders Society - Unified Parkinson's Disease Rating Scale assessment at the Study Day 60 visit
|
|
Movement Disorders Society - Unified Parkinson's Disease Rating Scale
Part 2
|
7.0 units on a scale
STANDARD_DEVIATION 4.24 • n=2 Participants • Evaluable Population: All patients in the safety population who complete at least the Movement Disorders Society - Unified Parkinson's Disease Rating Scale assessment at the Study Day 60 visit
|
11.8 units on a scale
STANDARD_DEVIATION 9.21 • n=28 Participants • Evaluable Population: All patients in the safety population who complete at least the Movement Disorders Society - Unified Parkinson's Disease Rating Scale assessment at the Study Day 60 visit
|
13.8 units on a scale
STANDARD_DEVIATION 8.66 • n=123 Participants • Evaluable Population: All patients in the safety population who complete at least the Movement Disorders Society - Unified Parkinson's Disease Rating Scale assessment at the Study Day 60 visit
|
13.3 units on a scale
STANDARD_DEVIATION 8.75 • n=153 Participants • Evaluable Population: All patients in the safety population who complete at least the Movement Disorders Society - Unified Parkinson's Disease Rating Scale assessment at the Study Day 60 visit
|
|
Movement Disorders Society - Unified Parkinson's Disease Rating Scale
Part 3
|
24.0 units on a scale
STANDARD_DEVIATION 2.83 • n=2 Participants • Evaluable Population: All patients in the safety population who complete at least the Movement Disorders Society - Unified Parkinson's Disease Rating Scale assessment at the Study Day 60 visit
|
23.4 units on a scale
STANDARD_DEVIATION 14.13 • n=28 Participants • Evaluable Population: All patients in the safety population who complete at least the Movement Disorders Society - Unified Parkinson's Disease Rating Scale assessment at the Study Day 60 visit
|
30.0 units on a scale
STANDARD_DEVIATION 26.0 • n=123 Participants • Evaluable Population: All patients in the safety population who complete at least the Movement Disorders Society - Unified Parkinson's Disease Rating Scale assessment at the Study Day 60 visit
|
28.7 units on a scale
STANDARD_DEVIATION 15.95 • n=153 Participants • Evaluable Population: All patients in the safety population who complete at least the Movement Disorders Society - Unified Parkinson's Disease Rating Scale assessment at the Study Day 60 visit
|
|
Movement Disorders Society - Unified Parkinson's Disease Rating Scale
Part 4
|
3.0 units on a scale
STANDARD_DEVIATION 0.00 • n=2 Participants • Evaluable Population: All patients in the safety population who complete at least the Movement Disorders Society - Unified Parkinson's Disease Rating Scale assessment at the Study Day 60 visit
|
5.3 units on a scale
STANDARD_DEVIATION 3.81 • n=28 Participants • Evaluable Population: All patients in the safety population who complete at least the Movement Disorders Society - Unified Parkinson's Disease Rating Scale assessment at the Study Day 60 visit
|
4.5 units on a scale
STANDARD_DEVIATION 4.04 • n=123 Participants • Evaluable Population: All patients in the safety population who complete at least the Movement Disorders Society - Unified Parkinson's Disease Rating Scale assessment at the Study Day 60 visit
|
4.6 units on a scale
STANDARD_DEVIATION 3.98 • n=153 Participants • Evaluable Population: All patients in the safety population who complete at least the Movement Disorders Society - Unified Parkinson's Disease Rating Scale assessment at the Study Day 60 visit
|
PRIMARY outcome
Timeframe: Baseline to Study Day 60Population: Overall Number of Participants Analyzed represented by initial number analyzed at study visit Day 60; Number may differ for each Part (1-4) due to availability of score data. Evaluable Population: all subjects in the safety population who complete at least the MDS-UPDRS assessment at the Study Day 60 visit. Evaluable population will be used to analyze MDS-UPDRS endpoint.
MDS-UPDRS: 4-part assessment of the multiple clinical disabilities of Parkinson's Disease. Part I (13 items; Score 0-52) examines non-motor experiences, Part II (13 items; Score 0-52) examines motor experiences, Part III (33 items; Score 0-132) examines the cardinal motor disabilities and Part IV (6 items; Score 0-24) examines motor complications. Each Part has 0-4 ratings, where 0 (no problems) to 4 (severe problems) and scores for each part are summed to calculate the total score which ranges from 0-260. Higher scores represent worse outcomes for each part and total score.
Outcome measures
| Measure |
DA Switchers
n=2 Participants
Parkinson's Disease patients that have switched to safinamide (XADAGO) from a dopamine agonist (DA)
|
MAO-B Switchers
n=28 Participants
Parkinson's Disease patients that have switched to safinamide (XADAGO) from a monoamine oxidase-B (MAO-B) inhibitor
|
MAO-B Naive
n=120 Participants
Parkinson's Disease patients taking safinamide (XADAGO) that are MAO-B inhibitor naïve.
|
|---|---|---|---|
|
Change From Baseline in Movement Disorders Society -Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Part 4
|
-0.5 score on a scale
Standard Deviation 3.54
|
-0.3 score on a scale
Standard Deviation 3.28
|
-0.2 score on a scale
Standard Deviation 3.05
|
|
Change From Baseline in Movement Disorders Society -Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Part 1
|
-5.0 score on a scale
Standard Deviation 5.66
|
-1.0 score on a scale
Standard Deviation 5.13
|
-1.9 score on a scale
Standard Deviation 6.16
|
|
Change From Baseline in Movement Disorders Society -Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Part 2
|
0.0 score on a scale
Standard Deviation 2.83
|
-2.3 score on a scale
Standard Deviation 5.40
|
-2.6 score on a scale
Standard Deviation 5.28
|
|
Change From Baseline in Movement Disorders Society -Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Part 3
|
1.5 score on a scale
Standard Deviation 2.12
|
-3.3 score on a scale
Standard Deviation 7.78
|
-4.5 score on a scale
Standard Deviation 11.10
|
PRIMARY outcome
Timeframe: Baseline to Study Day 60Population: Overall Number of Participants Analyzed represented by number analyzed at study visit Day 60. Safety Population: all subjects who sign informed consent form, complete baseline assessments, receive at least 1 dose of XADAGO. Safety population used to analyze all efficacy endpoints except MDS-UPDRS.
PDQ-39 is a patient-reported outcome designed to address aspects of functioning and well-being for those affected by PD. Each of the 39 items is rated using a 5 point Likert scale with 0 for never having difficulties/problems and 4 for always having difficulties/problems. The sum score of the 39 items will be calculated and used for analysis, with scores ranging from 0-156. Higher scores indicate worse outcomes.
Outcome measures
| Measure |
DA Switchers
n=1 Participants
Parkinson's Disease patients that have switched to safinamide (XADAGO) from a dopamine agonist (DA)
|
MAO-B Switchers
n=25 Participants
Parkinson's Disease patients that have switched to safinamide (XADAGO) from a monoamine oxidase-B (MAO-B) inhibitor
|
MAO-B Naive
n=97 Participants
Parkinson's Disease patients taking safinamide (XADAGO) that are MAO-B inhibitor naïve.
|
|---|---|---|---|
|
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Scores
|
-1.8 score on a scale
|
0.5 score on a scale
Standard Deviation 9.73
|
-0.5 score on a scale
Standard Deviation 9.90
|
PRIMARY outcome
Timeframe: Baseline to Study Day 60Population: Overall Number of Participants Analyzed represented by number analyzed at study visit Day 60. Safety Population: all subjects who sign informed consent form, complete baseline assessments, receive at least 1 dose of XADAGO. Safety population used to analyze all efficacy endpoints except MDS-UPDRS.
MoCA is a 30-point, 1-page test designed to assess several cognitive domains, including visuospatial abilities (5 points), naming (3 points), attention (6 points), language (3 points), abstraction (2 points), delayed recall (5 points), and orientation to time and place (6 points). The total score ranges from 0 to 30, with higher scores indicating better performances.
Outcome measures
| Measure |
DA Switchers
n=2 Participants
Parkinson's Disease patients that have switched to safinamide (XADAGO) from a dopamine agonist (DA)
|
MAO-B Switchers
n=28 Participants
Parkinson's Disease patients that have switched to safinamide (XADAGO) from a monoamine oxidase-B (MAO-B) inhibitor
|
MAO-B Naive
n=119 Participants
Parkinson's Disease patients taking safinamide (XADAGO) that are MAO-B inhibitor naïve.
|
|---|---|---|---|
|
Change From Baseline in Montreal Cognitive Assessment (MoCA) Total Score.
|
0.0 score on a scale
Standard Deviation 1.41
|
0.9 score on a scale
Standard Deviation 2.41
|
0.4 score on a scale
Standard Deviation 2.45
|
PRIMARY outcome
Timeframe: Study Day 60Population: Overall Number of Participants Analyzed represented by number analyzed at study visit Day 60. Safety Population: all subjects who sign informed consent form, complete baseline assessments, receive at least 1 dose of XADAGO. Safety population used to analyze all efficacy endpoints except MDS-UPDRS.
TSQM-9 consists of 9 questions to assess patients' satisfaction with medication using a range of responses from 1 (extremely dissatisfied) to (7 extremely satisfied). This patient reported outcome provides scores on three parts: effectiveness, convenience, and global satisfaction. The sum of the 9-questions will be calculated and used for analysis. The total score ranges from 0 to 63, with higher scores indicating better treatment satisfaction.
Outcome measures
| Measure |
DA Switchers
n=1 Participants
Parkinson's Disease patients that have switched to safinamide (XADAGO) from a dopamine agonist (DA)
|
MAO-B Switchers
n=25 Participants
Parkinson's Disease patients that have switched to safinamide (XADAGO) from a monoamine oxidase-B (MAO-B) inhibitor
|
MAO-B Naive
n=99 Participants
Parkinson's Disease patients taking safinamide (XADAGO) that are MAO-B inhibitor naïve.
|
|---|---|---|---|
|
Treatment Satisfaction Questionnaire for Medication (TSQM-9) Scores
|
56.0 score on a scale
|
38.9 score on a scale
Standard Deviation 7.73
|
41.0 score on a scale
Standard Deviation 9.81
|
PRIMARY outcome
Timeframe: Study Day 60CGI-C is a 7-point scale depicting a Principal Investigator or certified Health Care Professional designee rating of the patient's overall improvement using a range of responses from a minimum of 1 (very much improved) to a maximum of 7 (very much worse).
Outcome measures
| Measure |
DA Switchers
n=2 Participants
Parkinson's Disease patients that have switched to safinamide (XADAGO) from a dopamine agonist (DA)
|
MAO-B Switchers
n=34 Participants
Parkinson's Disease patients that have switched to safinamide (XADAGO) from a monoamine oxidase-B (MAO-B) inhibitor
|
MAO-B Naive
n=128 Participants
Parkinson's Disease patients taking safinamide (XADAGO) that are MAO-B inhibitor naïve.
|
|---|---|---|---|
|
Clinical Global Impression of Change (CGI-C)
No Change
|
1 Participants
|
6 Participants
|
31 Participants
|
|
Clinical Global Impression of Change (CGI-C)
Minimally Worse
|
0 Participants
|
2 Participants
|
7 Participants
|
|
Clinical Global Impression of Change (CGI-C)
Much Worse
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Clinical Global Impression of Change (CGI-C)
Very Much Improved
|
0 Participants
|
1 Participants
|
13 Participants
|
|
Clinical Global Impression of Change (CGI-C)
Much Improved
|
1 Participants
|
7 Participants
|
29 Participants
|
|
Clinical Global Impression of Change (CGI-C)
Minimally Improved
|
0 Participants
|
10 Participants
|
38 Participants
|
|
Clinical Global Impression of Change (CGI-C)
Very Much Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Study Day 60Population: Participants Analyzed does not match the Participant Flow because some patient data was not captured for the visit. Safety Population: all subjects who sign informed consent form, complete baseline assessments, receive at least 1 dose of XADAGO. Safety population used to analyze all efficacy endpoints except MDS-UPDRS.
PGI-C is a 7-point scale depicting a patient's rating of overall improvement using a range of responses from 1 (very much improved) to 7 (very much worse).
Outcome measures
| Measure |
DA Switchers
n=2 Participants
Parkinson's Disease patients that have switched to safinamide (XADAGO) from a dopamine agonist (DA)
|
MAO-B Switchers
n=25 Participants
Parkinson's Disease patients that have switched to safinamide (XADAGO) from a monoamine oxidase-B (MAO-B) inhibitor
|
MAO-B Naive
n=100 Participants
Parkinson's Disease patients taking safinamide (XADAGO) that are MAO-B inhibitor naïve.
|
|---|---|---|---|
|
Patient Global Impression of Change (PGI-C)
Much Improved
|
2 Participants
|
3 Participants
|
25 Participants
|
|
Patient Global Impression of Change (PGI-C)
Very Much Improved
|
0 Participants
|
1 Participants
|
9 Participants
|
|
Patient Global Impression of Change (PGI-C)
Minimally Improved
|
0 Participants
|
9 Participants
|
31 Participants
|
|
Patient Global Impression of Change (PGI-C)
No Change
|
0 Participants
|
8 Participants
|
30 Participants
|
|
Patient Global Impression of Change (PGI-C)
Minimally Worse
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Patient Global Impression of Change (PGI-C)
Much Worse
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Patient Global Impression of Change (PGI-C)
Very Much Worse
|
0 Participants
|
0 Participants
|
1 Participants
|
Adverse Events
DA Switchers
MAO-B Switchers
MAO-B Naive
Serious adverse events
| Measure |
DA Switchers
n=2 participants at risk
Parkinson's Disease patients that have switched to safinamide (XADAGO) from a dopamine agonist (DA)
|
MAO-B Switchers
n=34 participants at risk
Parkinson's Disease patients that have switched to safinamide (XADAGO) from a monoamine oxidase-B (MAO-B) inhibitor
|
MAO-B Naive
n=128 participants at risk
Parkinson's Disease patients taking safinamide (XADAGO) that are MAO-B inhibitor naïve.
|
|---|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/2 • 6 months
|
0.00%
0/34 • 6 months
|
0.78%
1/128 • 6 months
|
|
Cardiac disorders
Palpitations
|
0.00%
0/2 • 6 months
|
0.00%
0/34 • 6 months
|
0.78%
1/128 • 6 months
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/2 • 6 months
|
0.00%
0/34 • 6 months
|
0.78%
1/128 • 6 months
|
|
Gastrointestinal disorders
Postoperataive ileus
|
0.00%
0/2 • 6 months
|
0.00%
0/34 • 6 months
|
0.78%
1/128 • 6 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/2 • 6 months
|
0.00%
0/34 • 6 months
|
0.78%
1/128 • 6 months
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.00%
0/2 • 6 months
|
0.00%
0/34 • 6 months
|
0.78%
1/128 • 6 months
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/2 • 6 months
|
0.00%
0/34 • 6 months
|
0.78%
1/128 • 6 months
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/2 • 6 months
|
0.00%
0/34 • 6 months
|
0.78%
1/128 • 6 months
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/2 • 6 months
|
0.00%
0/34 • 6 months
|
0.78%
1/128 • 6 months
|
|
Injury, poisoning and procedural complications
Traumatic haemothorax
|
0.00%
0/2 • 6 months
|
0.00%
0/34 • 6 months
|
0.78%
1/128 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/2 • 6 months
|
0.00%
0/34 • 6 months
|
0.78%
1/128 • 6 months
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/2 • 6 months
|
2.9%
1/34 • 6 months
|
0.00%
0/128 • 6 months
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/2 • 6 months
|
0.00%
0/34 • 6 months
|
0.78%
1/128 • 6 months
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/2 • 6 months
|
2.9%
1/34 • 6 months
|
0.00%
0/128 • 6 months
|
Other adverse events
| Measure |
DA Switchers
n=2 participants at risk
Parkinson's Disease patients that have switched to safinamide (XADAGO) from a dopamine agonist (DA)
|
MAO-B Switchers
n=34 participants at risk
Parkinson's Disease patients that have switched to safinamide (XADAGO) from a monoamine oxidase-B (MAO-B) inhibitor
|
MAO-B Naive
n=128 participants at risk
Parkinson's Disease patients taking safinamide (XADAGO) that are MAO-B inhibitor naïve.
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • 6 months
|
8.8%
3/34 • 6 months
|
7.0%
9/128 • 6 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2 • 6 months
|
5.9%
2/34 • 6 months
|
3.1%
4/128 • 6 months
|
|
Nervous system disorders
Tremor
|
50.0%
1/2 • 6 months
|
2.9%
1/34 • 6 months
|
1.6%
2/128 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/2 • 6 months
|
5.9%
2/34 • 6 months
|
1.6%
2/128 • 6 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/2 • 6 months
|
5.9%
2/34 • 6 months
|
8.6%
11/128 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place