Trial Outcomes & Findings for Long-term Safety of Rivastigmine Capsule and Patch in Patients With Mild to Moderately-severe Dementia Associated With Parkinson's Disease (PDD) (NCT NCT00623103)
NCT ID: NCT00623103
Last Updated: 2011-11-28
Results Overview
The AEs were summarized by presenting the number and percentage of patients having any of the 4 AEs or discontinued due to any of the 4 predefined AEs (tremor, muscle rigidity, bradykinesia, and fall)in each treatment group. The 95% CIs associated with the rates were also presented.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
583 participants
Primary outcome timeframe
76 Weeks
Results posted on
2011-11-28
Participant Flow
Participant milestones
| Measure |
Rivastigmine Capsule
Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.
|
Rivastigmine Patch
Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm\^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm\^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm\^2 patch or the highest well tolerated dose was maintained until week 76.
|
|---|---|---|
|
Overall Study
STARTED
|
295
|
288
|
|
Overall Study
Safety Set: Received Study Drug
|
294
|
288
|
|
Overall Study
COMPLETED
|
184
|
175
|
|
Overall Study
NOT COMPLETED
|
111
|
113
|
Reasons for withdrawal
| Measure |
Rivastigmine Capsule
Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.
|
Rivastigmine Patch
Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm\^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm\^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm\^2 patch or the highest well tolerated dose was maintained until week 76.
|
|---|---|---|
|
Overall Study
Adverse Event
|
70
|
60
|
|
Overall Study
Unsatisfactory therapeutic effect
|
4
|
12
|
|
Overall Study
Withdrawal by Subject
|
18
|
24
|
|
Overall Study
Lost to Follow-up
|
4
|
1
|
|
Overall Study
Administrative problems
|
2
|
4
|
|
Overall Study
Death
|
11
|
11
|
|
Overall Study
Protocol deviation
|
2
|
1
|
Baseline Characteristics
Long-term Safety of Rivastigmine Capsule and Patch in Patients With Mild to Moderately-severe Dementia Associated With Parkinson's Disease (PDD)
Baseline characteristics by cohort
| Measure |
Rivastigmine Capsule
n=295 Participants
Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.
|
Rivastigmine Patch
n=288 Participants
Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm\^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm\^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm\^2 patch or the highest well tolerated dose was maintained until week 76.
|
Total
n=583 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
72.35 years
STANDARD_DEVIATION 6.295 • n=5 Participants
|
72.26 years
STANDARD_DEVIATION 6.352 • n=7 Participants
|
72.31 years
STANDARD_DEVIATION 6.318 • n=5 Participants
|
|
Sex: Female, Male
Female
|
88 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
185 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
207 Participants
n=5 Participants
|
191 Participants
n=7 Participants
|
398 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 76 WeeksPopulation: Safety Population consisted of all participants who received at least 1 dose of study drug and had 1 post-baseline safety measurement. Participants with observation at 76 weeks were included in this analysis.
The AEs were summarized by presenting the number and percentage of patients having any of the 4 AEs or discontinued due to any of the 4 predefined AEs (tremor, muscle rigidity, bradykinesia, and fall)in each treatment group. The 95% CIs associated with the rates were also presented.
Outcome measures
| Measure |
Rivastigmine Capsule
n=294 Participants
Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.
|
Rivastigmine Patch
n=288 Participants
Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm\^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm\^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm\^2 patch or the highest well tolerated dose was maintained until week 76.
|
|---|---|---|
|
Percentage of Participants With Adverse Events (AEs) Due, or Potentially Due, to Worsening of Parkinson Disease (PD) Motor Symptoms (Tremor, Muscle Rigidity, Bradykinesia, Fall)
Tremor
|
24.5 Percentage of participants
Interval 19.7 to 29.8
|
9.7 Percentage of participants
Interval 6.6 to 13.7
|
|
Percentage of Participants With Adverse Events (AEs) Due, or Potentially Due, to Worsening of Parkinson Disease (PD) Motor Symptoms (Tremor, Muscle Rigidity, Bradykinesia, Fall)
Muscle Rigidity
|
4.1 Percentage of participants
Interval 2.1 to 7.0
|
5.2 Percentage of participants
Interval 2.9 to 8.4
|
|
Percentage of Participants With Adverse Events (AEs) Due, or Potentially Due, to Worsening of Parkinson Disease (PD) Motor Symptoms (Tremor, Muscle Rigidity, Bradykinesia, Fall)
Bradykinesia
|
5.1 Percentage of participants
Interval 2.9 to 8.3
|
6.3 Percentage of participants
Interval 3.7 to 9.7
|
|
Percentage of Participants With Adverse Events (AEs) Due, or Potentially Due, to Worsening of Parkinson Disease (PD) Motor Symptoms (Tremor, Muscle Rigidity, Bradykinesia, Fall)
Fall
|
17.0 Percentage of participants
Interval 12.9 to 21.8
|
20.1 Percentage of participants
Interval 15.7 to 25.2
|
PRIMARY outcome
Timeframe: 76 WeeksPopulation: Safety Population consisted of all participants who received at least 1 dose of study drug and had 1 post-baseline safety measurement. Participants with observation at 76 weeks were included in this analysis.
The discontinuations due to these AEs were summarized by presenting the number and percentage of patients having any of the 4 AEs or discontinued due to any of the 4 predefined AEs (tremor, muscle rigidity, bradykinesia, and fall) in each treatment group. The 95% CIs associated with these rates were also presented.
Outcome measures
| Measure |
Rivastigmine Capsule
n=294 Participants
Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.
|
Rivastigmine Patch
n=288 Participants
Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm\^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm\^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm\^2 patch or the highest well tolerated dose was maintained until week 76.
|
|---|---|---|
|
Percentage of Participants With Study Drug Discontinuations Due to Predefined AEs That Are Due, or Potentially Due, to Worsening of PD Motor Symptoms (Tremor, Muscle Rigidity, Bradykinesia, Fall)
Tremor
|
2.4 Percentage of participants
Interval 1.0 to 4.8
|
0.7 Percentage of participants
Interval 0.1 to 2.5
|
|
Percentage of Participants With Study Drug Discontinuations Due to Predefined AEs That Are Due, or Potentially Due, to Worsening of PD Motor Symptoms (Tremor, Muscle Rigidity, Bradykinesia, Fall)
Muscle Rigidity
|
0.3 Percentage of participants
Interval 0.0 to 1.9
|
0.3 Percentage of participants
Interval 0.0 to 1.9
|
|
Percentage of Participants With Study Drug Discontinuations Due to Predefined AEs That Are Due, or Potentially Due, to Worsening of PD Motor Symptoms (Tremor, Muscle Rigidity, Bradykinesia, Fall)
Bradykinesia
|
1.0 Percentage of participants
Interval 0.2 to 3.0
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With Study Drug Discontinuations Due to Predefined AEs That Are Due, or Potentially Due, to Worsening of PD Motor Symptoms (Tremor, Muscle Rigidity, Bradykinesia, Fall)
Fall
|
1.0 Percentage of participants
Interval 0.2 to 3.0
|
1.4 Percentage of participants
Interval 0.4 to 3.5
|
SECONDARY outcome
Timeframe: From Baseline to Weeks 8, 16, 24, 52 and 76Population: Safety population consisted of all participants who received at least 1 dose of study drug and had 1 post-baseline safety measurement. "n" in each of the categories is the number of participants at each time point with non-missing baseline and post-baseline measurements.
Unified Parkinson Disease Rating Scale (UPDRS) is a 6 part Parkinson's disease specific rating scale that estimates clinical function taking into consideration both disability (functional deficits) and impairment (objective clinical signs). Part III records the motor examination in Items 18-31 rated on a scale of 0 to 4 with (0 being absent/ normal and 4 being the worse) for a total possible score of 0 to 56.
Outcome measures
| Measure |
Rivastigmine Capsule
n=294 Participants
Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.
|
Rivastigmine Patch
n=288 Participants
Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm\^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm\^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm\^2 patch or the highest well tolerated dose was maintained until week 76.
|
|---|---|---|
|
Change in Unified Parkinson Disease Rating Scale (UPDRS) Part III Motor Examination Scores at Weeks 8, 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline
Week 8 (n=276,277)
|
-0.4 Score on a scale
Standard Deviation 6.99
|
-0.9 Score on a scale
Standard Deviation 7.05
|
|
Change in Unified Parkinson Disease Rating Scale (UPDRS) Part III Motor Examination Scores at Weeks 8, 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline
Week 16 (n=254,252)
|
0.5 Score on a scale
Standard Deviation 7.72
|
-1.7 Score on a scale
Standard Deviation 7.44
|
|
Change in Unified Parkinson Disease Rating Scale (UPDRS) Part III Motor Examination Scores at Weeks 8, 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline
Week 24 (n=229,237)
|
0.1 Score on a scale
Standard Deviation 8.19
|
-1.4 Score on a scale
Standard Deviation 7.90
|
|
Change in Unified Parkinson Disease Rating Scale (UPDRS) Part III Motor Examination Scores at Weeks 8, 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline
Week 52 (n=203,206)
|
0.7 Score on a scale
Standard Deviation 8.66
|
1.6 Score on a scale
Standard Deviation 9.57
|
|
Change in Unified Parkinson Disease Rating Scale (UPDRS) Part III Motor Examination Scores at Weeks 8, 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline
Week 76 (n=183,175)
|
2.1 Score on a scale
Standard Deviation 9.98
|
2.1 Score on a scale
Standard Deviation 9.65
|
SECONDARY outcome
Timeframe: From Baseline to Weeks 16, 24, 52 and 76Population: Intent-to-treat population which included all patients who received at least 1 dose of study drug and had at least 1 pre- and post-baseline assessment for 1 of the efficacy variables. Last observation carried forward. (LOCF)
Mattis DRS-2 is a measure of cognitive status. The total score is the sum of 5 subscale scores: Attention \[0-37\], Initiation/Perservation \[0-37\] (performing alternating movements), Construction \[0-6\] (copying designs), Conceptualization \[0-39\] (similarities) and Memory \[0-25\] (sentence recall, design recognition)for a total possible score of 0-144. Higher score is reflective of better cognitive function, lower scores associated with more pronounced cognitive deficit. The change from baseline was calculated such that a positive number indicates an improvement.
Outcome measures
| Measure |
Rivastigmine Capsule
n=273 Participants
Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.
|
Rivastigmine Patch
n=273 Participants
Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm\^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm\^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm\^2 patch or the highest well tolerated dose was maintained until week 76.
|
|---|---|---|
|
Change in Mattis Dementia Rating Scale (Mattis DRS-2) Scores at Weeks 16, 24, 52 and 76 Compared to Baseline
Week 16
|
5.4 Score on a scale
Standard Deviation 11.98
|
3.4 Score on a scale
Standard Deviation 11.53
|
|
Change in Mattis Dementia Rating Scale (Mattis DRS-2) Scores at Weeks 16, 24, 52 and 76 Compared to Baseline
Week 24
|
6.5 Score on a scale
Standard Deviation 12.98
|
4.4 Score on a scale
Standard Deviation 12.85
|
|
Change in Mattis Dementia Rating Scale (Mattis DRS-2) Scores at Weeks 16, 24, 52 and 76 Compared to Baseline
Week 52
|
4.6 Score on a scale
Standard Deviation 13.62
|
1.3 Score on a scale
Standard Deviation 15.07
|
|
Change in Mattis Dementia Rating Scale (Mattis DRS-2) Scores at Weeks 16, 24, 52 and 76 Compared to Baseline
Week 76
|
3.9 Score on a scale
Standard Deviation 16.82
|
-1.4 Score on a scale
Standard Deviation 17.43
|
SECONDARY outcome
Timeframe: From Baseline to Weeks 16, 24, 52 and 76Population: Intent-to-treat population which included all patients who received at least 1 dose of study drug and had at least 1 pre- and post-baseline assessment for 1 of the efficacy variables. Last observation carried forward. (LOCF)
The Ten Point Clock Test measures executive functioning and visuospatial skills. Participants are asked to put numbers on the face of a clock and then make the clock read 10 minutes after 11. Points are awarded on a scale of 0 to 10 for spacing of specific numbers and the positions of the hands. The change from baseline was calculated such that a positive number indicates improvement.
Outcome measures
| Measure |
Rivastigmine Capsule
n=273 Participants
Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.
|
Rivastigmine Patch
n=273 Participants
Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm\^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm\^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm\^2 patch or the highest well tolerated dose was maintained until week 76.
|
|---|---|---|
|
Change in Ten Point Clock Test (TPCT) Scores at Weeks 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline
Week 16
|
0.5 Score on a scale
Standard Deviation 2.75
|
0.4 Score on a scale
Standard Deviation 3.02
|
|
Change in Ten Point Clock Test (TPCT) Scores at Weeks 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline
Week 24
|
0.6 Score on a scale
Standard Deviation 3.18
|
0.3 Score on a scale
Standard Deviation 3.40
|
|
Change in Ten Point Clock Test (TPCT) Scores at Weeks 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline
Week 52
|
0.3 Score on a scale
Standard Deviation 2.97
|
-0.1 Score on a scale
Standard Deviation 3.33
|
|
Change in Ten Point Clock Test (TPCT) Scores at Weeks 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline
Week 76
|
0.0 Score on a scale
Standard Deviation 3.2
|
-0.3 Score on a scale
Standard Deviation 3.57
|
SECONDARY outcome
Timeframe: At Week 16, 24, 52 and 76 (or early discontinuation)Population: Intent-to-treat population which included all patients who received at least 1 dose of study drug and had at least 1 pre- and post-baseline assessment for 1 of the efficacy variables. Last observation carried forward. (LOCF)
The parameter for analysis was the change from baseline of total score of 10 items on the NPI scale (NPI-10). The total score is a sum of the 10 domains, where the score for a domain is defined as the product of frequency (range: 1-4) and severity (range: 1-3). Each domain has a maximum score of 12 and all domains were equally weighted for total score(thus the range for the total score is 0 to 120 with 0 being completely healthy to 120 which is the worse score patient can get). The change from baseline was calculated such that a negative number indicates an improvement (symptom reduction).
Outcome measures
| Measure |
Rivastigmine Capsule
n=294 Participants
Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.
|
Rivastigmine Patch
n=288 Participants
Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm\^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm\^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm\^2 patch or the highest well tolerated dose was maintained until week 76.
|
|---|---|---|
|
Change in Neuropsychiatric Inventory-10 (NPI-10) Scores at Weeks 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline
Week 16
|
-3.3 Score
Standard Deviation 9.75
|
-0.5 Score
Standard Deviation 10.89
|
|
Change in Neuropsychiatric Inventory-10 (NPI-10) Scores at Weeks 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline
Week 24
|
-2.6 Score
Standard Deviation 10.31
|
-1.0 Score
Standard Deviation 10.27
|
|
Change in Neuropsychiatric Inventory-10 (NPI-10) Scores at Weeks 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline
Week 52
|
-1.7 Score
Standard Deviation 11.40
|
-0.3 Score
Standard Deviation 11.26
|
|
Change in Neuropsychiatric Inventory-10 (NPI-10) Scores at Weeks 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline
Week 76
|
-1.6 Score
Standard Deviation 11.22
|
0.7 Score
Standard Deviation 12.62
|
SECONDARY outcome
Timeframe: From Baseline to Week 16, 24, 52 and 76 (or early discontinuation)Population: Intent-to-treat population which included all patients who received at least 1 dose of study drug and had at least 1 pre- and post-baseline assessment for 1 of the efficacy variables. Last observation carried forward. (LOCF).
The 23 item caregiver-based ADL scale of the dementia Alzheimer's disease Cooperative Study-Activities of Daily Living (ADCS-ADL) was used for analysis. This is a caregiver rated questionnaire of 23 items, with possible scores over a range of 0-78, where 78 denote full functioning with no impairment. The total score was derived by adding up the item scores of the 23 items. The change from baseline was calculated such that a positive change indicates an improvement.
Outcome measures
| Measure |
Rivastigmine Capsule
n=294 Participants
Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.
|
Rivastigmine Patch
n=288 Participants
Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm\^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm\^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm\^2 patch or the highest well tolerated dose was maintained until week 76.
|
|---|---|---|
|
Change in Alzheimer's Disease Cooperative Study-Activities Of Daily Living (ADCS-ADL) Scores at Weeks 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline
Week 16 (n=273, 270)
|
-0.4 Score
Standard Deviation 9.60
|
-1.3 Score
Standard Deviation 10.38
|
|
Change in Alzheimer's Disease Cooperative Study-Activities Of Daily Living (ADCS-ADL) Scores at Weeks 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline
Week 24 (n=273,270)
|
-0.6 Score
Standard Deviation 10.12
|
-1.5 Score
Standard Deviation 10.91
|
|
Change in Alzheimer's Disease Cooperative Study-Activities Of Daily Living (ADCS-ADL) Scores at Weeks 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline
Week 52 (n=273,270)
|
-2.2 Score
Standard Deviation 11.13
|
-5.4 Score
Standard Deviation 13.57
|
|
Change in Alzheimer's Disease Cooperative Study-Activities Of Daily Living (ADCS-ADL) Scores at Weeks 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline
Week 76 (n=273, 270)
|
-4.4 Score
Standard Deviation 13.13
|
-7.8 Score
Standard Deviation 15.62
|
SECONDARY outcome
Timeframe: From Baseline to Week 8, 16, 24, 52 and 76 (or early discontinuation)Population: The Safety population consisted of all patients who have received at least one dose of study drug and have had at least 1 safety measurement after baseline. n=indicates patients with observation during different timepoints.
Unified Parkinson Disease Rating Scale (UPDRS) is a 6 part Parkinson's disease specific rating scale that estimates clinical function taking into consideration both disability (functional deficits) and impairment (objective clinical signs). UPDRS Part V is assessed by the modified Hoehn and Yahr Staging Scale. The scale ranges from 0 (no signs of disease) to 5 (wheelchair bound or bedridden unless aided).
Outcome measures
| Measure |
Rivastigmine Capsule
n=294 Participants
Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.
|
Rivastigmine Patch
n=288 Participants
Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm\^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm\^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm\^2 patch or the highest well tolerated dose was maintained until week 76.
|
|---|---|---|
|
UPDRS Part V Stage (Modified Hoehn and Yahr Staging)at Baseline, Week 8,16,24,52 and 76 (or Early Discontinuation)
Baseline (n = 294,288)
|
2.7 Score
Standard Deviation 0.65
|
2.7 Score
Standard Deviation 0.70
|
|
UPDRS Part V Stage (Modified Hoehn and Yahr Staging)at Baseline, Week 8,16,24,52 and 76 (or Early Discontinuation)
Week 8 (n=17,18)
|
2.6 Score
Standard Deviation 0.70
|
2.7 Score
Standard Deviation 1.05
|
|
UPDRS Part V Stage (Modified Hoehn and Yahr Staging)at Baseline, Week 8,16,24,52 and 76 (or Early Discontinuation)
Week 16 (n=254,252)
|
2.8 Score
Standard Deviation 0.68
|
2.7 Score
Standard Deviation 0.67
|
|
UPDRS Part V Stage (Modified Hoehn and Yahr Staging)at Baseline, Week 8,16,24,52 and 76 (or Early Discontinuation)
Week 24 (229, 236)
|
2.7 Score
Standard Deviation 0.75
|
2.7 Score
Standard Deviation 0.67
|
|
UPDRS Part V Stage (Modified Hoehn and Yahr Staging)at Baseline, Week 8,16,24,52 and 76 (or Early Discontinuation)
Week 52 (n=202,208)
|
2.8 Score
Standard Deviation 0.73
|
2.8 Score
Standard Deviation 0.69
|
|
UPDRS Part V Stage (Modified Hoehn and Yahr Staging)at Baseline, Week 8,16,24,52 and 76 (or Early Discontinuation)
Week 76 (n=184, 175)
|
2.8 Score
Standard Deviation 0.74
|
2.8 Score
Standard Deviation 0.79
|
Adverse Events
Exelon Capsule
Serious events: 87 serious events
Other events: 239 other events
Deaths: 0 deaths
Exelon Patch
Serious events: 83 serious events
Other events: 215 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Exelon Capsule
n=294 participants at risk
Exelon Capsule
|
Exelon Patch
n=288 participants at risk
Exelon Patch
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/294
|
0.35%
1/288
|
|
Cardiac disorders
Angina pectoris
|
0.34%
1/294
|
0.69%
2/288
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.34%
1/294
|
0.00%
0/288
|
|
Cardiac disorders
Atrial fibrillation
|
1.0%
3/294
|
0.00%
0/288
|
|
Cardiac disorders
Atrial flutter
|
0.34%
1/294
|
0.00%
0/288
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/294
|
0.35%
1/288
|
|
Cardiac disorders
Bradycardia
|
0.34%
1/294
|
0.00%
0/288
|
|
Cardiac disorders
Cardiac arrest
|
0.34%
1/294
|
0.00%
0/288
|
|
Cardiac disorders
Cardiac failure
|
0.34%
1/294
|
0.69%
2/288
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/294
|
0.35%
1/288
|
|
Cardiac disorders
Cardiac valve sclerosis
|
0.34%
1/294
|
0.00%
0/288
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.34%
1/294
|
0.35%
1/288
|
|
Cardiac disorders
Coronary artery disease
|
0.34%
1/294
|
0.35%
1/288
|
|
Cardiac disorders
Myocardial infarction
|
0.68%
2/294
|
0.69%
2/288
|
|
Cardiac disorders
Sinus arrhythmia
|
0.34%
1/294
|
0.00%
0/288
|
|
Gastrointestinal disorders
Abdominal distension
|
0.34%
1/294
|
0.00%
0/288
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.34%
1/294
|
0.00%
0/288
|
|
Gastrointestinal disorders
Abdominal pain
|
0.34%
1/294
|
0.00%
0/288
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.34%
1/294
|
0.00%
0/288
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/294
|
0.35%
1/288
|
|
Gastrointestinal disorders
Diarrhoea
|
0.34%
1/294
|
1.0%
3/288
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.34%
1/294
|
0.00%
0/288
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/294
|
0.35%
1/288
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/294
|
0.35%
1/288
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/294
|
0.35%
1/288
|
|
Gastrointestinal disorders
Ileus
|
0.34%
1/294
|
0.35%
1/288
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.34%
1/294
|
0.35%
1/288
|
|
Gastrointestinal disorders
Inguinal hernia strangulated
|
0.34%
1/294
|
0.00%
0/288
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.34%
1/294
|
0.35%
1/288
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/294
|
0.35%
1/288
|
|
Gastrointestinal disorders
Mesenteric occlusion
|
0.34%
1/294
|
0.35%
1/288
|
|
Gastrointestinal disorders
Nausea
|
0.68%
2/294
|
0.35%
1/288
|
|
Gastrointestinal disorders
Pancreatitis
|
0.34%
1/294
|
0.00%
0/288
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.34%
1/294
|
0.00%
0/288
|
|
Gastrointestinal disorders
Periodontitis
|
0.00%
0/294
|
0.35%
1/288
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/294
|
0.35%
1/288
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.34%
1/294
|
0.00%
0/288
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.68%
2/294
|
0.00%
0/288
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.34%
1/294
|
0.00%
0/288
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/294
|
0.35%
1/288
|
|
General disorders
Asthenia
|
0.34%
1/294
|
0.00%
0/288
|
|
General disorders
Complication of device insertion
|
0.00%
0/294
|
0.35%
1/288
|
|
General disorders
Device failure
|
0.34%
1/294
|
0.00%
0/288
|
|
General disorders
Fatigue
|
0.68%
2/294
|
0.00%
0/288
|
|
General disorders
Gait disturbance
|
0.00%
0/294
|
0.35%
1/288
|
|
General disorders
General physical health deterioration
|
0.34%
1/294
|
0.00%
0/288
|
|
General disorders
Non-cardiac chest pain
|
0.68%
2/294
|
0.00%
0/288
|
|
General disorders
Pyrexia
|
0.68%
2/294
|
1.0%
3/288
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.68%
2/294
|
0.35%
1/288
|
|
Infections and infestations
Bronchitis
|
0.34%
1/294
|
0.00%
0/288
|
|
Infections and infestations
Bronchopneumonia
|
0.34%
1/294
|
0.35%
1/288
|
|
Infections and infestations
Cellulitis
|
0.00%
0/294
|
0.35%
1/288
|
|
Infections and infestations
Cystitis klebsiella
|
0.34%
1/294
|
0.00%
0/288
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/294
|
0.35%
1/288
|
|
Infections and infestations
Gastrointestinal infection
|
0.68%
2/294
|
0.00%
0/288
|
|
Infections and infestations
Helicobacter infection
|
0.68%
2/294
|
0.00%
0/288
|
|
Infections and infestations
Lung infection
|
0.34%
1/294
|
0.00%
0/288
|
|
Infections and infestations
Pneumonia
|
3.1%
9/294
|
2.4%
7/288
|
|
Infections and infestations
Pneumonia fungal
|
0.34%
1/294
|
0.00%
0/288
|
|
Infections and infestations
Post procedural sepsis
|
0.00%
0/294
|
0.35%
1/288
|
|
Infections and infestations
Rash pustular
|
0.34%
1/294
|
0.00%
0/288
|
|
Infections and infestations
Respiratory tract infection
|
0.68%
2/294
|
0.00%
0/288
|
|
Infections and infestations
Sepsis
|
0.00%
0/294
|
0.35%
1/288
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/294
|
0.35%
1/288
|
|
Infections and infestations
Urinary tract infection
|
0.68%
2/294
|
1.4%
4/288
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/294
|
0.35%
1/288
|
|
Injury, poisoning and procedural complications
Brain herniation
|
0.34%
1/294
|
0.00%
0/288
|
|
Injury, poisoning and procedural complications
Concussion
|
0.34%
1/294
|
0.00%
0/288
|
|
Injury, poisoning and procedural complications
Contusion
|
0.68%
2/294
|
0.00%
0/288
|
|
Injury, poisoning and procedural complications
Fall
|
0.68%
2/294
|
3.1%
9/288
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.68%
2/294
|
0.35%
1/288
|
|
Injury, poisoning and procedural complications
Femur fracture
|
2.0%
6/294
|
1.0%
3/288
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.34%
1/294
|
0.00%
0/288
|
|
Injury, poisoning and procedural complications
Head injury
|
0.68%
2/294
|
0.00%
0/288
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.0%
3/294
|
0.69%
2/288
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/294
|
0.69%
2/288
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.34%
1/294
|
0.69%
2/288
|
|
Injury, poisoning and procedural complications
Nerve root injury
|
0.00%
0/294
|
0.35%
1/288
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/294
|
0.35%
1/288
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.34%
1/294
|
0.00%
0/288
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.34%
1/294
|
0.69%
2/288
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.34%
1/294
|
0.00%
0/288
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.34%
1/294
|
0.00%
0/288
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.34%
1/294
|
0.00%
0/288
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.34%
1/294
|
0.00%
0/288
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.34%
1/294
|
0.00%
0/288
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.34%
1/294
|
0.00%
0/288
|
|
Investigations
Weight decreased
|
0.00%
0/294
|
0.35%
1/288
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/294
|
0.35%
1/288
|
|
Metabolism and nutrition disorders
Dehydration
|
1.0%
3/294
|
1.4%
4/288
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.34%
1/294
|
0.00%
0/288
|
|
Metabolism and nutrition disorders
Weight loss poor
|
0.00%
0/294
|
0.35%
1/288
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/294
|
0.35%
1/288
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.68%
2/294
|
0.00%
0/288
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.34%
1/294
|
0.00%
0/288
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.00%
0/294
|
0.35%
1/288
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/294
|
0.35%
1/288
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.34%
1/294
|
0.00%
0/288
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/294
|
0.35%
1/288
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.34%
1/294
|
0.00%
0/288
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.34%
1/294
|
0.00%
0/288
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/294
|
0.35%
1/288
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.34%
1/294
|
0.00%
0/288
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma benign
|
0.00%
0/294
|
0.35%
1/288
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.34%
1/294
|
0.35%
1/288
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectosigmoid cancer
|
0.00%
0/294
|
0.35%
1/288
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Waldenstrom's macroglobulinaemia
|
0.00%
0/294
|
0.35%
1/288
|
|
Nervous system disorders
Akinesia
|
0.68%
2/294
|
1.0%
3/288
|
|
Nervous system disorders
Aphasia
|
0.00%
0/294
|
0.35%
1/288
|
|
Nervous system disorders
Balance disorder
|
0.34%
1/294
|
0.00%
0/288
|
|
Nervous system disorders
Basilar artery thrombosis
|
0.00%
0/294
|
0.35%
1/288
|
|
Nervous system disorders
Bradykinesia
|
0.68%
2/294
|
1.0%
3/288
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/294
|
0.69%
2/288
|
|
Nervous system disorders
Cerebrovascular accident
|
0.34%
1/294
|
0.00%
0/288
|
|
Nervous system disorders
Cognitive disorder
|
0.34%
1/294
|
0.00%
0/288
|
|
Nervous system disorders
Cogwheel rigidity
|
1.4%
4/294
|
0.69%
2/288
|
|
Nervous system disorders
Coma
|
0.00%
0/294
|
0.35%
1/288
|
|
Nervous system disorders
Convulsion
|
0.00%
0/294
|
0.35%
1/288
|
|
Nervous system disorders
Dementia
|
0.34%
1/294
|
0.00%
0/288
|
|
Nervous system disorders
Depressed level of consciousness
|
0.34%
1/294
|
0.00%
0/288
|
|
Nervous system disorders
Dizziness
|
0.34%
1/294
|
1.0%
3/288
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/294
|
0.35%
1/288
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/294
|
1.0%
3/288
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/294
|
0.69%
2/288
|
|
Nervous system disorders
Freezing phenomenon
|
0.68%
2/294
|
0.35%
1/288
|
|
Nervous system disorders
Hypokinesia
|
0.00%
0/294
|
0.35%
1/288
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/294
|
0.35%
1/288
|
|
Nervous system disorders
Loss of consciousness
|
0.34%
1/294
|
0.69%
2/288
|
|
Nervous system disorders
Monoparesis
|
0.00%
0/294
|
0.35%
1/288
|
|
Nervous system disorders
On and off phenomenon
|
1.0%
3/294
|
0.00%
0/288
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/294
|
0.35%
1/288
|
|
Nervous system disorders
Parkinsonian gait
|
1.0%
3/294
|
0.69%
2/288
|
|
Nervous system disorders
Parkinsonian rest tremor
|
1.0%
3/294
|
0.69%
2/288
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.68%
2/294
|
0.00%
0/288
|
|
Nervous system disorders
Psychomotor skills impaired
|
0.34%
1/294
|
0.00%
0/288
|
|
Nervous system disorders
Quadriplegia
|
0.34%
1/294
|
0.00%
0/288
|
|
Nervous system disorders
Somnolence
|
0.34%
1/294
|
0.35%
1/288
|
|
Nervous system disorders
Syncope
|
1.7%
5/294
|
0.35%
1/288
|
|
Nervous system disorders
Transient ischaemic attack
|
0.34%
1/294
|
1.4%
4/288
|
|
Psychiatric disorders
Agitation
|
0.00%
0/294
|
0.69%
2/288
|
|
Psychiatric disorders
Anxiety
|
0.34%
1/294
|
0.35%
1/288
|
|
Psychiatric disorders
Confusional state
|
1.0%
3/294
|
2.1%
6/288
|
|
Psychiatric disorders
Delirium
|
0.00%
0/294
|
0.69%
2/288
|
|
Psychiatric disorders
Delusion
|
0.34%
1/294
|
0.35%
1/288
|
|
Psychiatric disorders
Depression
|
0.00%
0/294
|
0.35%
1/288
|
|
Psychiatric disorders
Hallucination
|
0.34%
1/294
|
1.4%
4/288
|
|
Psychiatric disorders
Hallucination, visual
|
1.0%
3/294
|
1.0%
3/288
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/294
|
0.69%
2/288
|
|
Psychiatric disorders
Mental status changes
|
0.34%
1/294
|
0.00%
0/288
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/294
|
0.35%
1/288
|
|
Psychiatric disorders
Psychotic disorder due to a general medical condition
|
0.00%
0/294
|
0.35%
1/288
|
|
Renal and urinary disorders
Bladder trabeculation
|
0.00%
0/294
|
0.35%
1/288
|
|
Renal and urinary disorders
Calculus bladder
|
0.34%
1/294
|
0.00%
0/288
|
|
Renal and urinary disorders
Haematuria
|
0.34%
1/294
|
0.00%
0/288
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/294
|
0.35%
1/288
|
|
Renal and urinary disorders
Renal failure
|
0.34%
1/294
|
0.35%
1/288
|
|
Renal and urinary disorders
Urinary bladder polyp
|
0.34%
1/294
|
0.00%
0/288
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/294
|
0.35%
1/288
|
|
Renal and urinary disorders
Urinary retention
|
0.68%
2/294
|
0.00%
0/288
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.34%
1/294
|
0.00%
0/288
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.34%
1/294
|
0.00%
0/288
|
|
Reproductive system and breast disorders
Prostatic obstruction
|
0.00%
0/294
|
0.35%
1/288
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.34%
1/294
|
0.00%
0/288
|
|
Respiratory, thoracic and mediastinal disorders
Brain hypoxia
|
0.34%
1/294
|
0.35%
1/288
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.0%
3/294
|
0.35%
1/288
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/294
|
0.35%
1/288
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.34%
1/294
|
0.00%
0/288
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/294
|
0.35%
1/288
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/294
|
0.35%
1/288
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.4%
4/294
|
0.35%
1/288
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.34%
1/294
|
0.00%
0/288
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.34%
1/294
|
0.00%
0/288
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/294
|
0.35%
1/288
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.34%
1/294
|
0.00%
0/288
|
|
Vascular disorders
Haematoma
|
0.00%
0/294
|
0.35%
1/288
|
|
Vascular disorders
Hypertension
|
0.00%
0/294
|
0.69%
2/288
|
|
Vascular disorders
Hypertensive crisis
|
0.34%
1/294
|
0.35%
1/288
|
|
Vascular disorders
Hypotension
|
1.0%
3/294
|
0.00%
0/288
|
|
Vascular disorders
Orthostatic hypotension
|
0.34%
1/294
|
0.00%
0/288
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/294
|
0.35%
1/288
|
|
Vascular disorders
Phlebitis
|
0.34%
1/294
|
0.00%
0/288
|
Other adverse events
| Measure |
Exelon Capsule
n=294 participants at risk
Exelon Capsule
|
Exelon Patch
n=288 participants at risk
Exelon Patch
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
7.1%
21/294
|
7.3%
21/288
|
|
Gastrointestinal disorders
Diarrhoea
|
9.2%
27/294
|
4.9%
14/288
|
|
Gastrointestinal disorders
Nausea
|
39.8%
117/294
|
8.0%
23/288
|
|
Gastrointestinal disorders
Vomiting
|
15.3%
45/294
|
2.4%
7/288
|
|
General disorders
Application site erythema
|
0.00%
0/294
|
13.9%
40/288
|
|
General disorders
Fatigue
|
6.5%
19/294
|
4.5%
13/288
|
|
Infections and infestations
Urinary tract infection
|
5.8%
17/294
|
7.3%
21/288
|
|
Injury, poisoning and procedural complications
Fall
|
16.3%
48/294
|
17.0%
49/288
|
|
Investigations
Weight decreased
|
6.5%
19/294
|
6.2%
18/288
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.1%
18/294
|
4.2%
12/288
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.4%
13/294
|
5.6%
16/288
|
|
Nervous system disorders
Bradykinesia
|
4.4%
13/294
|
5.2%
15/288
|
|
Nervous system disorders
Dizziness
|
8.8%
26/294
|
7.3%
21/288
|
|
Nervous system disorders
Headache
|
5.1%
15/294
|
4.2%
12/288
|
|
Nervous system disorders
On and off phenomenon
|
4.1%
12/294
|
5.6%
16/288
|
|
Nervous system disorders
Parkinsonian gait
|
5.1%
15/294
|
4.2%
12/288
|
|
Nervous system disorders
Parkinsonian rest tremor
|
23.5%
69/294
|
9.0%
26/288
|
|
Nervous system disorders
Somnolence
|
7.8%
23/294
|
6.2%
18/288
|
|
Psychiatric disorders
Anxiety
|
5.8%
17/294
|
7.6%
22/288
|
|
Psychiatric disorders
Confusional state
|
7.1%
21/294
|
7.3%
21/288
|
|
Psychiatric disorders
Depression
|
2.0%
6/294
|
7.6%
22/288
|
|
Psychiatric disorders
Hallucination
|
6.5%
19/294
|
7.3%
21/288
|
|
Psychiatric disorders
Hallucination, visual
|
4.1%
12/294
|
5.6%
16/288
|
|
Psychiatric disorders
Insomnia
|
4.8%
14/294
|
8.0%
23/288
|
|
Vascular disorders
Hypertension
|
5.4%
16/294
|
4.2%
12/288
|
|
Vascular disorders
Hypotension
|
7.5%
22/294
|
3.5%
10/288
|
|
Vascular disorders
Orthostatic hypotension
|
6.1%
18/294
|
5.9%
17/288
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER