Trial Outcomes & Findings for Effect of Safinamide on Parkinson's Disease Related Chronic Pain (NCT NCT03841604)
NCT ID: NCT03841604
Last Updated: 2023-05-22
Results Overview
To evaluate the potential efficacy of safinamide 100 (mg od), compared to placebo, as add-on therapy, for change pain severity ("average worst pain experienced in the last 7 days"), as assessed by an 11-point Numerical Rating Scale (NRS). Based on this scale, 0 point is the minimum and 10 point is the maximum. The higher the score, the more severe the pain.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
94 participants
Primary outcome timeframe
Baseline and Week 16
Results posted on
2023-05-22
Participant Flow
A total of 94 subjects were enrolled in the study; 46 subjects were randomly assigned to safinamide and 25 subjects to placebo. Overall, 23 subjects were screen failures. Overall, 60 subjects (83.3%) completed the study, and 11 subjects discontinued from the study.
Participant milestones
| Measure |
Experimental
Safinamide methanesulfonate film coated tablets once daily, 50 mg and 100 mg. Safinamide methanesulfonate 50 mg and 100 mg tablets was administered orally, OD, with or without food, at breakfast time when the subject was taking their morning dose of L-DOPA. Subjects received study drug 50 mg (from Day 1 to Day 7) and then 100 mg (from Day 8 onwards). The dose of 100 mg/day (titrated from 50 mg/day after 1 week) was selected based on the results of previous studies in patients with PD and from the results of a post hoc analysis that investigated the effects of safinamide on pain
|
Placebo
Safinamide methanesulfonate matching placebo film coated tablets once daily. The matching placebo was administered orally, OD, in tablets, with or without food, at breakfast time when the subject was taking their morning dose of L-DOPA.
|
|---|---|---|
|
Overall Study
STARTED
|
46
|
25
|
|
Overall Study
COMPLETED
|
38
|
22
|
|
Overall Study
NOT COMPLETED
|
8
|
3
|
Reasons for withdrawal
| Measure |
Experimental
Safinamide methanesulfonate film coated tablets once daily, 50 mg and 100 mg. Safinamide methanesulfonate 50 mg and 100 mg tablets was administered orally, OD, with or without food, at breakfast time when the subject was taking their morning dose of L-DOPA. Subjects received study drug 50 mg (from Day 1 to Day 7) and then 100 mg (from Day 8 onwards). The dose of 100 mg/day (titrated from 50 mg/day after 1 week) was selected based on the results of previous studies in patients with PD and from the results of a post hoc analysis that investigated the effects of safinamide on pain
|
Placebo
Safinamide methanesulfonate matching placebo film coated tablets once daily. The matching placebo was administered orally, OD, in tablets, with or without food, at breakfast time when the subject was taking their morning dose of L-DOPA.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
|
Overall Study
Adverse Event
|
4
|
2
|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Effect of Safinamide on Parkinson's Disease Related Chronic Pain
Baseline characteristics by cohort
| Measure |
Experimental
n=46 Participants
Safinamide methanesulfonate film coated tablets once daily
Safinamide Methanesulfonate: 50 mg, 100 mg
|
Placebo
n=25 Participants
Safinamide methanesulfonate matching placebo film coated tablets once daily
Safinamide methanesulfonate matching placebo: 50 mg, 100 mg
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
27 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Age, Continuous
|
66.3 years
STANDARD_DEVIATION 10.55 • n=5 Participants
|
66.4 years
STANDARD_DEVIATION 11.82 • n=7 Participants
|
66.3 years
STANDARD_DEVIATION 10.93 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 16Population: Full Analysis Set:All randomized subjects in the study, with at least one measurement of the primary efficacy variable following at least one dose of study drug. Please note that n (39 and 20) above reported is the number of subjects with observed average worst pain score.
To evaluate the potential efficacy of safinamide 100 (mg od), compared to placebo, as add-on therapy, for change pain severity ("average worst pain experienced in the last 7 days"), as assessed by an 11-point Numerical Rating Scale (NRS). Based on this scale, 0 point is the minimum and 10 point is the maximum. The higher the score, the more severe the pain.
Outcome measures
| Measure |
Experimental
n=39 Participants
Safinamide methanesulfonate film coated tablets once daily
Safinamide Methanesulfonate: 50 mg, 100 mg
|
Placebo
n=20 Participants
Safinamide methanesulfonate matching placebo film coated tablets once daily
Safinamide methanesulfonate matching placebo: 50 mg, 100 mg
|
|---|---|---|
|
Change From Baseline to Week 16 in Pain Severity (NRS-11 Scale) - Full Analysis Set
|
-1.6 score on a scale
Standard Deviation 2.01
|
-0.8 score on a scale
Standard Deviation 1.29
|
PRIMARY outcome
Timeframe: Baseline and Week 16Population: Per Protocol Set : The PP set was a subset of subjects in the FAS who completed the study and for whom no relevant protocol deviations were documented
To evaluate the potential efficacy of safinamide 100 (mg od), compared to placebo, as add-on therapy, for change pain severity ("average worst pain experienced in the last 7 days"), as assessed by an 11-point Numerical Rating Scale (NRS). Based on this scale, 0 point is the minimum and 10 point is the maximum. The higher the score, the more severe the pain.
Outcome measures
| Measure |
Experimental
n=35 Participants
Safinamide methanesulfonate film coated tablets once daily
Safinamide Methanesulfonate: 50 mg, 100 mg
|
Placebo
n=19 Participants
Safinamide methanesulfonate matching placebo film coated tablets once daily
Safinamide methanesulfonate matching placebo: 50 mg, 100 mg
|
|---|---|---|
|
Change From Baseline to Week 16 in Pain Severity (NRS-11 Scale) - Per Protocol Set
|
-1.6 score on a scale
Standard Error 2.05
|
-0.8 score on a scale
Standard Error 1.33
|
SECONDARY outcome
Timeframe: Week 16Population: Full Analysis Set: All randomized subjects in the study, with at least one measurement of the primary efficacy variable following at least one dose of study drug.
Reduction in pain severity (based on the "average worst pain experienced in the last 7 days") of ≥ 2 points was assessed by an 11-point NRS (numerical rating scale), compared to baseline. Based on this scale, 0 point is the minimum and 10 point is the maximum. The higher the score, the more severe the pain.
Outcome measures
| Measure |
Experimental
n=45 Participants
Safinamide methanesulfonate film coated tablets once daily
Safinamide Methanesulfonate: 50 mg, 100 mg
|
Placebo
n=23 Participants
Safinamide methanesulfonate matching placebo film coated tablets once daily
Safinamide methanesulfonate matching placebo: 50 mg, 100 mg
|
|---|---|---|
|
Number of Subjects With a Reduction of ≥2 Points in Pain Severity at Week 16, Compared to Baseline
|
15 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: Full Analysis Set: Full Analysis Set: All randomized subjects in the study, with at least one measurement of the primary efficacy variable following at least one dose of study drug. Please note that n above reported (37 and 20) is the number of subjects with observed CGI-C score.
CGI-C (Clinical Global Impression - Change) score for pain is a seven-point scale that indicates the patient's impression of change for relevant symptoms. It ranges from "substantial improvement" to "substantial worsening": 1. = substantial improvement; 2. = moderate improvement; 3. = minimum improvement; 4. = No change; 5. = Minimum worsening; 6. = moderate worsening; 7. = substantial worsening. of course the higher the score, the worse the outcome.
Outcome measures
| Measure |
Experimental
n=37 Participants
Safinamide methanesulfonate film coated tablets once daily
Safinamide Methanesulfonate: 50 mg, 100 mg
|
Placebo
n=20 Participants
Safinamide methanesulfonate matching placebo film coated tablets once daily
Safinamide methanesulfonate matching placebo: 50 mg, 100 mg
|
|---|---|---|
|
The Change From Baseline to Week 16 in the Clinical Global Impression of Change (CGI-C) Score for Pain
|
3.4 score on a scale
Standard Deviation 1.09
|
3.5 score on a scale
Standard Deviation 1.00
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: Full Analysis Set: All randomized subjects in the study, with at least one measurement of the primary efficacy variable following at least one dose of study drug. Please note that n (44 and 22) here reported is the number of subjects with observed CGI-S score.
The CGI-S (Clinical Global Impression - Severity) score is a seven-point scale which asks the clinician one question: "considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" which is rated as follow: 1. = normal, not at all ill; 2. = borderline mentally ill; 3. = mildly ill; 4. = moderately ill; 5. = markedly ill; 6. = severely ill; 7. = among the most severely ill patients. of course the higher the score, the worse the outcome.
Outcome measures
| Measure |
Experimental
n=44 Participants
Safinamide methanesulfonate film coated tablets once daily
Safinamide Methanesulfonate: 50 mg, 100 mg
|
Placebo
n=22 Participants
Safinamide methanesulfonate matching placebo film coated tablets once daily
Safinamide methanesulfonate matching placebo: 50 mg, 100 mg
|
|---|---|---|
|
The Global Impression of Severity (CGI-S) Score for Pain at Week 16
Week 16
|
3.4 score on a scale
Standard Deviation 0.76
|
3.5 score on a scale
Standard Deviation 0.76
|
|
The Global Impression of Severity (CGI-S) Score for Pain at Week 16
Baseline
|
3.8 score on a scale
Standard Deviation 0.65
|
3.8 score on a scale
Standard Deviation 0.66
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: Full Analysis Set: All randomized subjects in the study, with at least one measurement of the primary efficacy variable following at least one dose of study drug. Please note that n (33 and 20) here reported is the number of subjects with observed PGI-C score.
The Patients' Global Impression of Change (PGI-C) scale is designed to capture the subject's perception of change in activity limitations, symptoms, emotions, an overall quality of life. These areas are captured using a 7- point scale, indicating: 1. = no change (or condition has got worse); 2. = almost the same, hardly any change at all; 3. = a little better, but not noticeable change; 4. = somewhat better, but the change has not made any real difference; 5. = moderately better, and a slight but noticeable change; 6. = better and a definite improvement that has made a real and worthwhile difference; 7. = a great deal better, and a considerable improvement that has made all the difference. Of course, the higher the score, the better the outcome.
Outcome measures
| Measure |
Experimental
n=33 Participants
Safinamide methanesulfonate film coated tablets once daily
Safinamide Methanesulfonate: 50 mg, 100 mg
|
Placebo
n=20 Participants
Safinamide methanesulfonate matching placebo film coated tablets once daily
Safinamide methanesulfonate matching placebo: 50 mg, 100 mg
|
|---|---|---|
|
The Change From Baseline to Week 16 in the Patient Global Impression of Change (PGI-C) Score for Pain
|
2.7 score on a scale
Standard Deviation 1.33
|
2.5 score on a scale
Standard Deviation 1.28
|
SECONDARY outcome
Timeframe: Baseline, weeks 4, 8 and 16Population: Full Analysis Set: All randomized subjects in the study, with at least one measurement of the primary efficacy variable following at least one dose of study drug.
This outcome describes the number of subjects which had concomitant assumption of pain drugs at different timepoints.
Outcome measures
| Measure |
Experimental
n=45 Participants
Safinamide methanesulfonate film coated tablets once daily
Safinamide Methanesulfonate: 50 mg, 100 mg
|
Placebo
n=23 Participants
Safinamide methanesulfonate matching placebo film coated tablets once daily
Safinamide methanesulfonate matching placebo: 50 mg, 100 mg
|
|---|---|---|
|
Number of Subjects With Concomitant Use of Pain Drugs at Different Timepoints
Subjects with Concomitant Pain Drug at baseline
|
0 participants
|
0 participants
|
|
Number of Subjects With Concomitant Use of Pain Drugs at Different Timepoints
Subjects with Concomitant Pain Drug at week 4
|
0 participants
|
1 participants
|
|
Number of Subjects With Concomitant Use of Pain Drugs at Different Timepoints
Subjects with Concomitant Pain Drug at week 8
|
0 participants
|
0 participants
|
|
Number of Subjects With Concomitant Use of Pain Drugs at Different Timepoints
Subjects with Concomitant Pain Drug at week 16
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: at Baseline and weeks 4, 8 and 16Population: Full Analysis Set:All randomized subjects in the study, with at least one measurement of the primary efficacy variable following at least one dose of study drug.
Total count of patients who used PRN (meaning "when necessary") Parkinson's Disease Pain Medications was expressed both in number and in percentage. The analysis of amount of concomitant PRN PD pain medications as reported in the subject diary was summarized: * as the number of subjects who were taking pain medication in the 7 days preceding visits at different timepoints; * in the number of days on which PRN PD pain medication was taken at different timepoints.
Outcome measures
| Measure |
Experimental
n=45 Participants
Safinamide methanesulfonate film coated tablets once daily
Safinamide Methanesulfonate: 50 mg, 100 mg
|
Placebo
n=23 Participants
Safinamide methanesulfonate matching placebo film coated tablets once daily
Safinamide methanesulfonate matching placebo: 50 mg, 100 mg
|
|---|---|---|
|
Amount of PRN PD Pain Medication: Count of Subjects Who Used PRN PD Pain Medication in the 7 Days Preceding Visits
Subjects with PRN PD Pain Medication at Baseline
|
12 Participants
|
7 Participants
|
|
Amount of PRN PD Pain Medication: Count of Subjects Who Used PRN PD Pain Medication in the 7 Days Preceding Visits
Subjects with PRN PD Pain Medication at week 4
|
8 Participants
|
5 Participants
|
|
Amount of PRN PD Pain Medication: Count of Subjects Who Used PRN PD Pain Medication in the 7 Days Preceding Visits
Subjects with PRN PD Pain Medication at week 8
|
5 Participants
|
4 Participants
|
|
Amount of PRN PD Pain Medication: Count of Subjects Who Used PRN PD Pain Medication in the 7 Days Preceding Visits
Subjects with PRN PD Pain Medication at week 16
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: At Baseline and weeks 4, 8 and 16Population: Full Analysis Set: All randomized subjects in the study, with at least one measurement of the primary efficacy variable following at least one dose of study drug.
The analysis of amount of concomitant PRN PD pain medications as reported in the subject diary was summarized: * as the number of days on which PRN PD pain medication was taken at different timepoints. * as the number of subjects who were taking pain medication in the 7 days preceding visits at different timepoints.
Outcome measures
| Measure |
Experimental
n=27 Participants
Safinamide methanesulfonate film coated tablets once daily
Safinamide Methanesulfonate: 50 mg, 100 mg
|
Placebo
n=19 Participants
Safinamide methanesulfonate matching placebo film coated tablets once daily
Safinamide methanesulfonate matching placebo: 50 mg, 100 mg
|
|---|---|---|
|
Amount of PRN PD Pain Medication: Number of Days on Which PRN PD Pain Medication Was Taken at Different Timepoints
Baseline
|
3.2 number of days
Standard Deviation 2.44
|
4.1 number of days
Standard Deviation 2.34
|
|
Amount of PRN PD Pain Medication: Number of Days on Which PRN PD Pain Medication Was Taken at Different Timepoints
week 4
|
4.8 number of days
Standard Deviation 2.76
|
4.3 number of days
Standard Deviation 3.20
|
|
Amount of PRN PD Pain Medication: Number of Days on Which PRN PD Pain Medication Was Taken at Different Timepoints
week 8
|
6.0 number of days
Standard Deviation 2.00
|
4.5 number of days
Standard Deviation 1.00
|
|
Amount of PRN PD Pain Medication: Number of Days on Which PRN PD Pain Medication Was Taken at Different Timepoints
week 16
|
4.5 number of days
Standard Deviation 1.73
|
5.3 number of days
Standard Deviation 1.71
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: Full Analysis Set: All randomized subjects in the study, with at least one measurement of the primary efficacy variable following at least one dose of study drug. Please note that n (33 and 20) is the number of subjects with observed HADS score.
The Hospital Anxiety and Depression Scale (HADS) was devised to measure anxiety and depression in a general medical population of patients through a unique questionnaire which takes 2-5 min to be completed. The questionnaire consists of a total of 14 items: seven items for the anxiety subscale (HADS Anxiety) and seven items for the depression subscale (HADS Depression). HADS Anxiety focus mainly on symptoms of generalized anxiety disorder and HADS Depression is focused on anhedonia, the main symptom of depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for anxiety subscale and the same for depression subscale, where: 0-7 = Normal 8-10 = Borderline abnormal (borderline case). 11-21 = Abnormal (case) The two subscores are then summed up to obtain a total Hospital Anxiety and Depression Scale (HADS). The total scale range is 0-42. The higher the score, the worse the anxiety/depression status.
Outcome measures
| Measure |
Experimental
n=33 Participants
Safinamide methanesulfonate film coated tablets once daily
Safinamide Methanesulfonate: 50 mg, 100 mg
|
Placebo
n=20 Participants
Safinamide methanesulfonate matching placebo film coated tablets once daily
Safinamide methanesulfonate matching placebo: 50 mg, 100 mg
|
|---|---|---|
|
Change From Baseline to Week 16 in the Hospital Anxiety and Depression Scale (HADS) Score
|
-1.5 score on a scale
Standard Deviation 6.03
|
-2.0 score on a scale
Standard Deviation 4.36
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: Full Analysis Set: All randomized subjects in the study, with at least one measurement of the primary efficacy variable following at least one dose of study drug. Please note that n (31 and 19) is the number of subjects with observed MDS-UPDRS score
Change in the MDS-UPDRS = Movement Disorder Society-Unified Parkinson's Disease Rating Scale The MDS-UPDRS is defined by 4 Parts, each composed by a different number of items. Each item is rated on a 5-point Likert-type scale (ranging from 0 to 4); Part I (non-motor experiences of daily living; 13 items) Part II (motor experiences of daily living;13 items) Part III (motor examination; 33 items) Part IV (motor complications; 6 items) The MDS-UPDRS has a minimum score of 0 and a maximum score of 260. The higher the score, the more severe the impairment.
Outcome measures
| Measure |
Experimental
n=31 Participants
Safinamide methanesulfonate film coated tablets once daily
Safinamide Methanesulfonate: 50 mg, 100 mg
|
Placebo
n=19 Participants
Safinamide methanesulfonate matching placebo film coated tablets once daily
Safinamide methanesulfonate matching placebo: 50 mg, 100 mg
|
|---|---|---|
|
The Change From Baseline to Week 16 in MDS-UPDRS
|
-6.8 score on a scale
Standard Deviation 13.79
|
-4.8 score on a scale
Standard Deviation 11.68
|
Adverse Events
Experimental
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Experimental
n=46 participants at risk
Safinamide methanesulfonate film coated tablets once daily
Safinamide Methanesulfonate: 50 mg, 100 mg
|
Placebo
n=25 participants at risk
Safinamide methanesulfonate matching placebo film coated tablets once daily
Safinamide methanesulfonate matching placebo: 50 mg, 100 mg
|
|---|---|---|
|
Psychiatric disorders
Depression
|
0.00%
0/46 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
|
Nervous system disorders
Lacunar Infarction
|
0.00%
0/46 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
Other adverse events
| Measure |
Experimental
n=46 participants at risk
Safinamide methanesulfonate film coated tablets once daily
Safinamide Methanesulfonate: 50 mg, 100 mg
|
Placebo
n=25 participants at risk
Safinamide methanesulfonate matching placebo film coated tablets once daily
Safinamide methanesulfonate matching placebo: 50 mg, 100 mg
|
|---|---|---|
|
Nervous system disorders
Hyperkinesia
|
4.3%
2/46 • Number of events 2 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
0.00%
0/25 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
|
Nervous system disorders
Headache
|
2.2%
1/46 • Number of events 1 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
0.00%
0/25 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/46 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
|
Nervous system disorders
Motor dysfunction
|
0.00%
0/46 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
|
Nervous system disorders
Paraesthesia
|
2.2%
1/46 • Number of events 1 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
0.00%
0/25 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/46 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
|
Nervous system disorders
Somnolence
|
2.2%
1/46 • Number of events 1 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
0.00%
0/25 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
|
Nervous system disorders
Syncope
|
2.2%
1/46 • Number of events 1 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
0.00%
0/25 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/46 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
|
Eye disorders
Pterygium
|
2.2%
1/46 • Number of events 1 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
0.00%
0/25 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
|
Gastrointestinal disorders
Constipation
|
6.5%
3/46 • Number of events 3 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
0.00%
0/25 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
|
Gastrointestinal disorders
Dyspepsia
|
4.3%
2/46 • Number of events 2 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
0.00%
0/25 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
|
Gastrointestinal disorders
Nausea
|
4.3%
2/46 • Number of events 2 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
0.00%
0/25 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/46 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
|
Gastrointestinal disorders
Dysphagia
|
2.2%
1/46 • Number of events 1 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
0.00%
0/25 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
2.2%
1/46 • Number of events 1 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
0.00%
0/25 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
2.2%
1/46 • Number of events 1 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
0.00%
0/25 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
|
Gastrointestinal disorders
Tongue ulceration
|
2.2%
1/46 • Number of events 1 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
0.00%
0/25 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
|
General disorders
Fatigue
|
2.2%
1/46 • Number of events 1 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
8.0%
2/25 • Number of events 2 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
|
General disorders
Pyrexia
|
0.00%
0/46 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
8.0%
2/25 • Number of events 2 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
|
General disorders
Oedema peripheral
|
2.2%
1/46 • Number of events 1 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
0.00%
0/25 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
|
General disorders
Pain
|
0.00%
0/46 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
|
Infections and infestations
Nasopharyngitis
|
2.2%
1/46 • Number of events 1 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
|
Infections and infestations
Respiratory tract infection
|
2.2%
1/46 • Number of events 1 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
0.00%
0/25 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.2%
1/46 • Number of events 1 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
0.00%
0/25 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
|
Investigations
Blood pressure increased
|
0.00%
0/46 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.3%
2/46 • Number of events 2 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
0.00%
0/25 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
2.2%
1/46 • Number of events 1 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
0.00%
0/25 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.2%
1/46 • Number of events 1 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
0.00%
0/25 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.2%
1/46 • Number of events 1 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
0.00%
0/25 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.2%
1/46 • Number of events 1 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
0.00%
0/25 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
|
Nervous system disorders
Dizziness
|
2.2%
1/46 • Number of events 1 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
|
Nervous system disorders
Dyskinesia
|
4.3%
2/46 • Number of events 2 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
0.00%
0/25 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
|
Psychiatric disorders
Hallucination
|
2.2%
1/46 • Number of events 1 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/46 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
|
Psychiatric disorders
Depression
|
0.00%
0/46 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
|
Psychiatric disorders
Hallucination, visual
|
2.2%
1/46 • Number of events 1 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
0.00%
0/25 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
2.2%
1/46 • Number of events 1 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
0.00%
0/25 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/46 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.2%
1/46 • Number of events 1 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
0.00%
0/25 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.2%
1/46 • Number of events 1 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
0.00%
0/25 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.2%
1/46 • Number of events 1 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
0.00%
0/25 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
|
Vascular disorders
Hypertension
|
2.2%
1/46 • Number of events 1 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
0.00%
0/25 • Adverse events were collected Up to 14 days before Day 1 (Screening period), at baseline, at week 4-8-16 and at follow up period, up to 19 weeks.
Please note that TEAEs were reported in the CSR for safinamide (whichever was the dose) and placebo, separately. No differenciacion between IMP doses for TEAE was done, nor is available.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place