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Trial record 1 of 13 for:    Steady PD III
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Efficacy of Isradipine in Early Parkinson Disease

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ClinicalTrials.gov Identifier: NCT02168842
Recruitment Status : Completed
First Posted : June 20, 2014
Results First Posted : January 14, 2020
Last Update Posted : January 14, 2020
Sponsor:
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
Michael J. Fox Foundation for Parkinson's Research
The Parkinson Study Group
Information provided by (Responsible Party):
Robert Holloway, University of Rochester

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Parkinson Disease
Interventions Drug: Isradipine
Drug: Placebo (for Isradipine)
Enrollment 336
Recruitment Details Patients were recruited from 57 Parkinson Study Group sites in North America from November 2014 through November 2015.
Pre-assignment Details 413 patients were assessed for eligibility. 12 patients declined to participate and 65 patients were excluded (9 exclusionary medications, 2 other medical psychiatric or surgical, 5 disease too advanced, 6 diagnosis uncertain, 23 didn't meet other inclusion criteria, 20 other). 336 patients were enrolled and underwent randomization
Arm/Group Title Isradipine Placebo (for Isradipine)
Hide Arm/Group Description Receive Isradipine 5 mg twice daily for 36 months. Isradipine: oral immediate-release capsule of Isradipine 10 mg per day. Receive placebo twice daily for 36 months. Placebo: Sugar Pill manufactured to look like Isradipine but has no active ingredients
Period Title: Overall Study
Started 170 166
Completed 162 158
Not Completed 8 8
Reason Not Completed
Withdrawal by Subject             5             3
Lost to Follow-up             0             2
Death             2             1
Physician Decision             1             2
Arm/Group Title Isradipine Placebo (for Isradipine) Total
Hide Arm/Group Description

Oral capsule of up to 5 mg of isradipine taken twice daily for 36 months.

Isradipine: Oral capsules Isradipine IR, up to 10 mg, taken twice daily

Oral capsule taken twice daily for 36 months.

Placebo (for Isradipine): Sugar Pill manufactured to look like Isradipine but has no active ingredients

Total of all reporting groups
Overall Number of Baseline Participants 170 166 336
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 170 participants 166 participants 336 participants
62.11  (8.73) 61.61  (9.34) 61.86  (9.03)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 170 participants 166 participants 336 participants
Female
48
  28.2%
58
  34.9%
106
  31.5%
Male
122
  71.8%
108
  65.1%
230
  68.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 170 participants 166 participants 336 participants
Hispanic or Latino
4
   2.4%
6
   3.6%
10
   3.0%
Not Hispanic or Latino
166
  97.6%
160
  96.4%
326
  97.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 170 participants 166 participants 336 participants
American Indian or Alaska Native
1
   0.6%
1
   0.6%
2
   0.6%
Asian
6
   3.5%
5
   3.0%
11
   3.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   0.6%
1
   0.3%
Black or African American
3
   1.8%
7
   4.2%
10
   3.0%
White
159
  93.5%
149
  89.8%
308
  91.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   0.6%
3
   1.8%
4
   1.2%
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 170 participants 166 participants 336 participants
154 149 303
Canada Number Analyzed 170 participants 166 participants 336 participants
16 17 33
[1]
Measure Description: Enrolled patients were from 54 Parkinson Study Group sites in North America. 7 locate in Canada and 47 locate in United States.
Disease Duration   [1] 
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 170 participants 166 participants 336 participants
9.89  (8.13) 10.56  (9.35) 10.22  (8.75)
[1]
Measure Description: Months from diagnosis.
Family History of PD   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 170 participants 166 participants 336 participants
30
  17.6%
35
  21.1%
65
  19.3%
[1]
Measure Description: First degree relatives only
Handedness  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 170 participants 166 participants 336 participants
Right
147
  86.5%
142
  85.5%
289
  86.0%
Left
20
  11.8%
19
  11.4%
39
  11.6%
Mixed
3
   1.8%
5
   3.0%
8
   2.4%
On Symptomatic Therapy (Amantadine)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 170 participants 166 participants 336 participants
15
   8.8%
11
   6.6%
26
   7.7%
On Symptomatic Therapy (Anticholinergics)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 170 participants 166 participants 336 participants
3
   1.8%
2
   1.2%
5
   1.5%
UPDRS Total Score   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 170 participants 165 participants 335 participants
23.66  (8.64) 22.58  (8.53) 23.13  (8.59)
[1]
Measure Description: Baseline total Unified Parkinson Disease Rating Scale (UPDRS) score ranges from 0 to 52. Larger value stands for more disability from PD.
[2]
Measure Analysis Population Description: One participant had missing baseline UPDRS
Mental Scale   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 170 participants 165 participants 335 participants
0.61  (0.87) 0.81  (1.21) 0.71  (1.05)
[1]
Measure Description: Baseline UPDRS Mental (UPDRS Part I: Mentation, Behavior, and Mood) score ranges from 0 to 7. Larger value stands for more disability from PD.
[2]
Measure Analysis Population Description: One participant had missing baseline UPDRS
ADL Scale   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 170 participants 165 participants 335 participants
4.96  (2.88) 5.45  (3.26) 5.2  (3.08)
[1]
Measure Description: Baseline UPDRS ADL (Part II) score ranges from 0 to 16. Larger value stands for more disability from PD. UPDRS Part II: self-evaluation of the activities of daily life (ADLs) including speech, swallowing, handwriting, dressing, hygiene, falling, salivating, turning in bed, walking, and cutting food.
[2]
Measure Analysis Population Description: One participant had missing baseline UPDRS
Motor Scale   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 170 participants 165 participants 335 participants
18.08  (7.3) 16.32  (6.53) 17.21  (6.97)
[1]
Measure Description: Baseline UPDRS Motor (Part III) score ranges from 0 to 42. Larger value stands for more disability from PD. UPDRS part III: clinician-scored monitored motor evaluation
[2]
Measure Analysis Population Description: One participant had missing baseline UPDRS
UPSDRS PIGD Score   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 170 participants 165 participants 335 participants
0.17  (0.19) 0.17  (0.17) 0.17  (0.18)
[1]
Measure Description: Baseline UPDRS PIGD score ranges from 0 to 1. Larger value stands for more disability from PD.
[2]
Measure Analysis Population Description: One participant had missing baseline UPDRS PIGD Score
UPDRS Tremor Score   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 170 participants 165 participants 335 participants
0.51  (0.32) 0.50  (0.29) 0.51  (0.3)
[1]
Measure Description: Baseline UPDRS Tremor score ranges from 0 to 1.63. Larger value stands for more disability from PD.
[2]
Measure Analysis Population Description: One participant had missing baseline UPDRS Tremor Score
H/Y Stage   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 170 participants 166 participants 336 participants
1.72  (0.46) 1.6  (0.5) 1.66  (0.48)
[1]
Measure Description: Hoehn and Yahr staging of severity of Parkinson's disease. Baseline H/Y stage ranges from 1 to 3. Larger value stands for more disability from PD.
SE/ADL   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 170 participants 166 participants 336 participants
94.44  (5.23) 94.04  (6.8) 94.24  (6.05)
[1]
Measure Description: Schwab and England ADL scale. Baseline SE/ADL ranges from 40 to 100. Smaller value stands for more disability from PD.
Modified Rankin Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 170 participants 166 participants 336 participants
1.09  (0.31) 1.09  (0.33) 1.09  (0.32)
[1]
Measure Description: The modified Rankin Scale (mRS) measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Baseline Modified Rankin score ranges from 0 to 2. Larger value stands for more disability from PD.
MoCA Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 170 participants 166 participants 336 participants
28.14  (1.41) 28.04  (1.29) 28.09  (1.35)
[1]
Measure Description: Montreal Cognitive Assessment (MoCA) is one-page 30-point test to detect cognitive impairment. Baseline MoCA score ranges from 23 to 30. Higher scores indicate better cognition.
BDI Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 170 participants 166 participants 336 participants
4.09  (3.71) 4.8  (4.29) 4.44  (4.02)
[1]
Measure Description: Baseline Beck Depression Inventory (BDI) score ranges from 0 to 23. Higher scores indicate greater symptom severity.
PDQ39 Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 170 participants 166 participants 336 participants
7.13  (6.15) 9.08  (8.52) 8.10  (7.47)
[1]
Measure Description: Parkinson's Disease Questionnaire-39 is a 39-item self-report questionnaire, which assesses Parkinson's disease-specific health related quality over the past month. Baseline PDQ 39 score ranges from 0 to 52. Lower score shows better quality of life.
Systolic BP, Seated  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 170 participants 166 participants 336 participants
128.12  (17.17) 127.69  (14.6) 127.91  (15.93)
Diastolic BP, Seated  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 170 participants 166 participants 336 participants
76.55  (9.72) 77.83  (8.52) 77.18  (9.16)
1.Primary Outcome
Title Adjusted Mean Change in Total Unified Parkinson Disease Rating Scale (UPDRS) Score
Hide Description Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the total (Part I-III) UPDRS score in the active treatment arm versus placebo between the baseline and 36 month visit. The change of UPDRS ranges from -30 to 80, larger value shows more disability from PD.
Time Frame Baseline to 36 months of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) population
Arm/Group Title Isradipine Placebo (for Isradipine)
Hide Arm/Group Description:

Oral capsule of up to 5 mg of isradipine taken twice daily for 36 months.

Isradipine: Oral capsules Isradipine IR, up to 10 mg, taken twice daily

Oral capsule taken twice daily for 36 months.

Placebo (for Isradipine): Sugar Pill manufactured to look like Isradipine but has no active ingredients

Overall Number of Participants Analyzed 162 158
Least Squares Mean (95% Confidence Interval)
Unit of Measure: score on a scale
2.99
(0.95 to 5.03)
3.26
(1.25 to 5.26)
2.Primary Outcome
Title Adjusted Mean Change in Adjusted UPDRS Score
Hide Description Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the adjusted UPDRS Score in the active treatment arm versus placebo between the baseline and 36 month visit. The change of adjusted UPDRS ranges from -100 to 150, larger value shows more disability from PD.
Time Frame Baseline to 36 months of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) population
Arm/Group Title Isradipine Placebo (for Isradipine)
Hide Arm/Group Description:
Receive Isradipine 5 mg twice daily for 36 months. Isradipine: oral immediate-release capsule of Isradipine 10 mg per day.
Receive placebo twice daily for 36 months. Placebo: Sugar Pill manufactured to look like Isradipine but has no active ingredients
Overall Number of Participants Analyzed 162 158
Least Squares Mean (95% Confidence Interval)
Unit of Measure: score on a scale
13.49
(11.32 to 15.66)
13.85
(11.72 to 15.98)
3.Secondary Outcome
Title Adjusted Mean Change in LED
Hide Description Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the LED(levodopa equivalent dose) in the active treatment arm versus placebo between the baseline and 36 month visit. The change of LED ranges from -100 to 3000, larger value shows more disability from PD.
Time Frame Baseline to 36 months of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) population. One participant had missing baseline UPDRS sections while had finished baseline LED measurement. So LED had 1 more observation than primary outcomes.
Arm/Group Title Isradipine Placebo (for Isradipine)
Hide Arm/Group Description:
Receive Isradipine 5 mg twice daily for 36 months. Isradipine: oral immediate-release capsule of Isradipine 10 mg per day.
Receive placebo twice daily for 36 months. Placebo: Sugar Pill manufactured to look like Isradipine but has no active ingredients
Overall Number of Participants Analyzed 162 159
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mg
389
(337 to 441)
375
(325 to 426)
4.Secondary Outcome
Title Adjusted Mean Change in LED Cumulative
Hide Description Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the LED(levodopa equivalent dose) cumulative in the active treatment arm versus placebo between the baseline and 36 month visit. The change of LED cumulative ranges from 0 to 1200000, larger value shows more disability from PD.
Time Frame Baseline to 36 months of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) population. One participant had missing baseline UPDRS sections while had finished baseline LED Cumulative measurement. So LED Cumulative had 1 more observation than primary outcomes.
Arm/Group Title Isradipine Placebo (for Isradipine)
Hide Arm/Group Description:
Receive Isradipine 5 mg twice daily for 36 months. Isradipine: oral immediate-release capsule of Isradipine 10 mg per day.
Receive placebo twice daily for 36 months. Placebo: Sugar Pill manufactured to look like Isradipine but has no active ingredients
Overall Number of Participants Analyzed 162 159
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mg
676
(588 to 765)
697
(611 to 784)
5.Secondary Outcome
Title Adjusted Mean Change in UPDRS Part IV
Hide Description Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the UPDRS Part IV in the active treatment arm versus placebo between the baseline and 36 month visit. The change in UPDRS Part IV ranges from -10 to 10, larger value shows more disability from PD.
Time Frame Baseline to 36 months of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) population. 46 patients had missing measures at the visit of 36 months.
Arm/Group Title Isradipine Placebo (for Isradipine)
Hide Arm/Group Description:
Receive Isradipine 5 mg twice daily for 36 months. Isradipine: oral immediate-release capsule of Isradipine 10 mg per day.
Receive placebo twice daily for 36 months. Placebo: Sugar Pill manufactured to look like Isradipine but has no active ingredients
Overall Number of Participants Analyzed 134 140
Least Squares Mean (95% Confidence Interval)
Unit of Measure: score on a scale
1.18
(0.9 to 1.46)
1.07
(0.8 to 1.33)
6.Secondary Outcome
Title Adjusted Mean Change in MDS-UPDRS nmEDL
Hide Description Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the MDS-UPDRS nmEDL(Non-Motor Experiences of Daily Living) in the active treatment arm versus placebo between the baseline and 36 month visit. The change in MDS-UPDRS nmEDL ranges from -6 to 10, larger value shows more disability from PD.
Time Frame Baseline to 36 months of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) population.
Arm/Group Title Isradipine Placebo (for Isradipine)
Hide Arm/Group Description:
Receive Isradipine 5 mg twice daily for 36 months. Isradipine: oral immediate-release capsule of Isradipine 10 mg per day.
Receive placebo twice daily for 36 months. Placebo: Sugar Pill manufactured to look like Isradipine but has no active ingredients
Overall Number of Participants Analyzed 162 158
Least Squares Mean (95% Confidence Interval)
Unit of Measure: score on a scale
1.93
(1.28 to 2.59)
1.76
(1.13 to 2.4)
7.Secondary Outcome
Title Adjusted Mean Change in MDS-UPDRS mEDL
Hide Description Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the MDS-UPDRS mEDL(Motor Experiences of Daily Living) in the active treatment arm versus placebo between the baseline and 36 month visit. The change in MDS-UPDRS mEDL ranges from -8 to 35, larger value shows more disability from PD.
Time Frame Baseline to 36 months of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) population
Arm/Group Title Isradipine Placebo (for Isradipine)
Hide Arm/Group Description:
Receive Isradipine 5 mg twice daily for 36 months. Isradipine: oral immediate-release capsule of Isradipine 10 mg per day.
Receive placebo twice daily for 36 months. Placebo: Sugar Pill manufactured to look like Isradipine but has no active ingredients
Overall Number of Participants Analyzed 162 158
Least Squares Mean (95% Confidence Interval)
Unit of Measure: score on a scale
2.32
(1.52 to 3.12)
2.57
(1.78 to 3.35)
8.Secondary Outcome
Title Adjusted Mean Change in UPDRS Score to 1 Year
Hide Description Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the MDS-UPDRS nmEDL(Non-Motor Experiences of Daily Living) in the active treatment arm versus placebo between the baseline and 12 month visit. The change of UPDRS ranges from -22 to 23, larger value shows more disability from PD.
Time Frame Baseline to 12 months of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) population. There were 169 patients in Isradipine group and 165 in placebo group who reached 1-year visit.
Arm/Group Title Isradipine Placebo (for Isradipine)
Hide Arm/Group Description:
Receive Isradipine 5 mg twice daily for 36 months. Isradipine: oral immediate-release capsule of Isradipine 10 mg per day.
Receive placebo twice daily for 36 months. Placebo: Sugar Pill manufactured to look like Isradipine but has no active ingredients
Overall Number of Participants Analyzed 169 165
Least Squares Mean (95% Confidence Interval)
Unit of Measure: score on a scale
4.65
(3.59 to 5.70)
5.3
(4.25 to 6.35)
9.Secondary Outcome
Title Adjusted Mean Change in UPDRS Part II
Hide Description Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the UPDRS Part II (ADL Function) in the active treatment arm versus placebo between the baseline and 36 month visit. The change in UPDRS Part II ranges from -12 to 19, larger value shows more disability from PD.
Time Frame Baseline to 36 months of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) population
Arm/Group Title Isradipine Placebo (for Isradipine)
Hide Arm/Group Description:
Receive Isradipine 5 mg twice daily for 36 months. Isradipine: oral immediate-release capsule of Isradipine 10 mg per day.
Receive placebo twice daily for 36 months. Placebo: Sugar Pill manufactured to look like Isradipine but has no active ingredients
Overall Number of Participants Analyzed 162 158
Least Squares Mean (95% Confidence Interval)
Unit of Measure: score on a scale
2.3
(1.63 to 3.97)
2.5
(1.83 to 3.16)
10.Secondary Outcome
Title Adjusted Mean Change in UPDRS Part III OFF
Hide Description Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the UPDRS Part III OFF rating in the active treatment arm versus placebo between the baseline and 36 month visit. The change in UPDRS Part III OFF ranges from -30 to 100, larger value shows more disability from PD.
Time Frame Baseline to 36 months of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) population. 58 patients had missing measures at the visit of 36 months.
Arm/Group Title Isradipine Placebo (for Isradipine)
Hide Arm/Group Description:
Receive Isradipine 5 mg twice daily for 36 months. Isradipine: oral immediate-release capsule of Isradipine 10 mg per day.
Receive placebo twice daily for 36 months. Placebo: Sugar Pill manufactured to look like Isradipine but has no active ingredients
Overall Number of Participants Analyzed 129 133
Least Squares Mean (95% Confidence Interval)
Unit of Measure: score on a scale
4.60
(3.05 to 6.14)
4.50
(3.02 to 5.98)
11.Secondary Outcome
Title Adjusted Mean Change in SE/ADL
Hide Description Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the SE/ADL in the active treatment arm versus placebo between the baseline and 36 month visit. The change of UPDRS ranges from -70 to 20, larger value shows improvement of PD.
Time Frame Baseline to 36 months of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) population. One participant had missing baseline UPDRS sections while had finished baseline SE/ADL measurement. So SE/ADL had 1 more observation than primary outcomes.
Arm/Group Title Isradipine Placebo (for Isradipine)
Hide Arm/Group Description:
Receive Isradipine 5 mg twice daily for 36 months. Isradipine: oral immediate-release capsule of Isradipine 10 mg per day.
Receive placebo twice daily for 36 months. Placebo: Sugar Pill manufactured to look like Isradipine but has no active ingredients
Overall Number of Participants Analyzed 162 159
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-4.14
(-5.30 to -2.98)
-4.41
(-5.54 to -3.27)
12.Secondary Outcome
Title Adjusted Mean Change in Modified Rankin Score
Hide Description Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the Modified Rankin Score in the active treatment arm versus placebo between the baseline and 36 month visit. The change in Modified Rankin Score ranges from -1 to 3, larger value shows worsening of conditions.
Time Frame Baseline to 36 months of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) population. One participant had missing baseline measurement for primary efficacy while had finished baseline Modified Rankin Score. So Modified Rankin Score had 1 more observation than primary outcomes.
Arm/Group Title Isradipine Placebo (for Isradipine)
Hide Arm/Group Description:
Receive Isradipine 5 mg twice daily for 36 months. Isradipine: oral immediate-release capsule of Isradipine 10 mg per day.
Receive placebo twice daily for 36 months. Placebo: Sugar Pill manufactured to look like Isradipine but has no active ingredients
Overall Number of Participants Analyzed 162 159
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
0.18
(0.07 to 0.28)
0.29
(0.18 to 0.39)
13.Secondary Outcome
Title Adjusted Mean Change in MoCA Score
Hide Description Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the MoCA Score in the active treatment arm versus placebo between the baseline and 36 month visit. The change in MoCA Score ranges from -10 to 6, larger value shows improvement of conditions.
Time Frame Baseline to 36 months of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) population. One participant had missing baseline UPDRS sections while had finished baseline MoCA Score. So MoCA Score had 1 observation more than primary outcomes.
Arm/Group Title Isradipine Placebo (for Isradipine)
Hide Arm/Group Description:
Receive Isradipine 5 mg twice daily for 36 months. Isradipine: oral immediate-release capsule of Isradipine 10 mg per day.
Receive placebo twice daily for 36 months. Placebo: Sugar Pill manufactured to look like Isradipine but has no active ingredients
Overall Number of Participants Analyzed 162 159
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-0.04
(-0.36 to 0.28)
-0.07
(-0.39 to 0.25)
14.Secondary Outcome
Title Adjusted Mean Change in PDQ39 Total Score
Hide Description Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the PDQ39 Total Score in the active treatment arm versus placebo between the baseline and 36 month visit. The change in PDQ39 Total Score ranges from -16 to 44, larger value shows worsening of conditions.
Time Frame Baseline to 36 months of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) population. 7 patients had missing PDQ39 scores at the visit of 36 months.
Arm/Group Title Isradipine Placebo (for Isradipine)
Hide Arm/Group Description:
Receive Isradipine 5 mg twice daily for 36 months. Isradipine: oral immediate-release capsule of Isradipine 10 mg per day.
Receive placebo twice daily for 36 months. Placebo: Sugar Pill manufactured to look like Isradipine but has no active ingredients
Overall Number of Participants Analyzed 158 155
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
2.80
(1.42 to 4.18)
3.42
(2.07 to 4.77)
15.Secondary Outcome
Title Adjusted Mean Change in Ambulatory Capacity
Hide Description Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the Ambulatory Capacity in the active treatment arm versus placebo between the baseline and 36 month visit. The change in Ambulatory Capacity ranges from -4 to 12, larger value shows worsening of conditions.
Time Frame Baseline to 36 months of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) population
Arm/Group Title Isradipine Placebo (for Isradipine)
Hide Arm/Group Description:
Receive Isradipine 5 mg twice daily for 36 months. Isradipine: oral immediate-release capsule of Isradipine 10 mg per day.
Receive placebo twice daily for 36 months. Placebo: Sugar Pill manufactured to look like Isradipine but has no active ingredients
Overall Number of Participants Analyzed 162 158
Least Squares Mean (95% Confidence Interval)
Unit of Measure: score on a scale
0.59
(0.34 to 0.85)
0.50
(0.25 to 0.75)
16.Secondary Outcome
Title Adjusted Mean Change in BDI Total Score
Hide Description Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the BDI Total Score in the active treatment arm versus placebo between the baseline and 36 month visit. The change in BDI Total Score ranges from -9 to 22, larger value shows worsening of conditions.
Time Frame Baseline to 36 months of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) population. One participant in Placebo group had missing baseline UPDRS sections while had finished baseline BDI Score. And one participant in Isradipine group had missing BDI score at the visit of 36 months.
Arm/Group Title Isradipine Placebo (for Isradipine)
Hide Arm/Group Description:
Receive Isradipine 5 mg twice daily for 36 months. Isradipine: oral immediate-release capsule of Isradipine 10 mg per day.
Receive placebo twice daily for 36 months. Placebo: Sugar Pill manufactured to look like Isradipine but has no active ingredients
Overall Number of Participants Analyzed 161 159
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
0.77
(0.05 to 1.49)
1.34
(0.63 to 2.04)
17.Secondary Outcome
Title Risk of Need for Antiparkinsonian Therapy
Hide Description Number of participants with need for Antiparkinsonian Therapy.
Time Frame Baseline to 36 months of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Include all 336 patients that were randomized, no matter whether or not completed the study.
Arm/Group Title Isradipine Placebo (for Isradipine)
Hide Arm/Group Description:
Receive Isradipine 5 mg twice daily for 36 months. Isradipine: oral immediate-release capsule of Isradipine 10 mg per day.
Receive placebo twice daily for 36 months. Placebo: Sugar Pill manufactured to look like Isradipine but has no active ingredients
Overall Number of Participants Analyzed 170 166
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: participants
145
(134 to 153)
147
(138 to 154)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Isradipine, Placebo (for Isradipine)
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Comparison of the risk of need for antiparkinsonian therapy in Isradipine group to the risk in placebo group.
Statistical Test of Hypothesis P-Value 0.073
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.79
Confidence Interval (2-Sided) 95%
0.61 to 1.03
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Risk of Need for Dyskinesia
Hide Description Number of participants with need for Dyskinesia Therapy.
Time Frame Baseline to 36 months of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Include all 336 patients that were randomized, no matter whether or not completed the study.
Arm/Group Title Isradipine Placebo (for Isradipine)
Hide Arm/Group Description:
Receive Isradipine 5 mg twice daily for 36 months. Isradipine: oral immediate-release capsule of Isradipine 10 mg per day.
Receive placebo twice daily for 36 months. Placebo: Sugar Pill manufactured to look like Isradipine but has no active ingredients
Overall Number of Participants Analyzed 170 166
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: participants
24
(17 to 34)
19
(12 to 28)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Isradipine, Placebo (for Isradipine)
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Comparison the risk of need for dyskinesia in Isradipine group to the risk in a placebo group.
Statistical Test of Hypothesis P-Value 0.21
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.53
Confidence Interval (2-Sided) 95%
0.78 to 3.01
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Risk of Need for Fluctuations
Hide Description Number of participants with need for Fluctuations Therapy.
Time Frame Baseline to 36 months of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Include all 336 patients that were randomized, no matter whether or not completed the study.
Arm/Group Title Isradipine Placebo (for Isradipine)
Hide Arm/Group Description:
Receive Isradipine 5 mg twice daily for 36 months. Isradipine: oral immediate-release capsule of Isradipine 10 mg per day.
Receive placebo twice daily for 36 months. Placebo: Sugar Pill manufactured to look like Isradipine but has no active ingredients
Overall Number of Participants Analyzed 170 166
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: participants
57
(46 to 70)
64
(51 to 76)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Isradipine, Placebo (for Isradipine)
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Comparison of the risk of need for antiparkinsonian therapy in Isradipine group to the risk in placebo group.
Statistical Test of Hypothesis P-Value 0.35
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.83
Confidence Interval (2-Sided) 95%
0.56 to 1.22
Estimation Comments [Not Specified]
20.Other Pre-specified Outcome
Title Adjusted Mean Change in UPDRS PIGD Score
Hide Description Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the UPDRS PIGD Score in the active treatment arm versus placebo between the baseline and 36 month visit. The change in UPDRS PIGD Score ranges from -1 to 3, larger value shows worsening of conditions.
Time Frame Baseline to 36 months of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) population
Arm/Group Title Isradipine Placebo (for Isradipine)
Hide Arm/Group Description:
Receive Isradipine 5 mg twice daily for 36 months. Isradipine: oral immediate-release capsule of Isradipine 10 mg per day.
Receive placebo twice daily for 36 months. Placebo: Sugar Pill manufactured to look like Isradipine but has no active ingredients
Overall Number of Participants Analyzed 162 158
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
0.12
(0.07 to 0.17)
0.10
(0.05 to 0.15)
21.Other Pre-specified Outcome
Title Adjusted Mean Change in UPDRS Tremor Score
Hide Description Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the UPDRS Tremor Score in the active treatment arm versus placebo between the baseline and 36 month visit. The change in UPDRS Tremor Score ranges from -1 to 2, larger value shows worsening of conditions.
Time Frame Baseline to 36 months of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) population
Arm/Group Title Isradipine Placebo (for Isradipine)
Hide Arm/Group Description:
Receive Isradipine 5 mg twice daily for 36 months. Isradipine: oral immediate-release capsule of Isradipine 10 mg per day.
Receive placebo twice daily for 36 months. Placebo: Sugar Pill manufactured to look like Isradipine but has no active ingredients
Overall Number of Participants Analyzed 162 158
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
0.00
(-0.05 to 0.05)
0.01
(-0.03 to 0.06)
22.Other Pre-specified Outcome
Title Adjusted Mean Change in H/Y Stage
Hide Description Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the H/Y Stage in the active treatment arm versus placebo between the baseline and 36 month visit. The change in H/Y Stage ranges from -1 to 3, larger value shows worsening of conditions.
Time Frame Baseline to 36 months of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) population. One participant had missing baseline UPDRS sections while had finished baseline H/Y Stage. So H/Y Stage had 1 observation more than primary outcomes.
Arm/Group Title Isradipine Placebo (for Isradipine)
Hide Arm/Group Description:
Receive Isradipine 5 mg twice daily for 36 months. Isradipine: oral immediate-release capsule of Isradipine 10 mg per day.
Receive placebo twice daily for 36 months. Placebo: Sugar Pill manufactured to look like Isradipine but has no active ingredients
Overall Number of Participants Analyzed 162 159
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
0.15
(0.09 to 0.22)
0.21
(0.15 to 0.28)
23.Other Pre-specified Outcome
Title Adjusted Mean Change in Levodopa
Hide Description Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the Levodopa in the active treatment arm versus placebo between the baseline and 36 month visit. The change of LED ranges from -200 to 2000, larger value shows more disability from PD.
Time Frame Baseline to 36 months of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) population. One participant had missing baseline UPDRS sections while had finished baseline Levodopa. So Levodopa had 1 observation more than primary outcomes.
Arm/Group Title Isradipine Placebo (for Isradipine)
Hide Arm/Group Description:
Receive Isradipine 5 mg twice daily for 36 months. Isradipine: oral immediate-release capsule of Isradipine 10 mg per day.
Receive placebo twice daily for 36 months. Placebo: Sugar Pill manufactured to look like Isradipine but has no active ingredients
Overall Number of Participants Analyzed 162 159
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mg
307
(257 to 356)
307
(259 to 355)
24.Other Pre-specified Outcome
Title Adjusted Mean Change in Levodopa Cumulative
Hide Description Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the Levodopa Cumulative in the active treatment arm versus placebo between the baseline and 36 month visit. The change of Levodopa cumulative ranges from 0 to 800000, larger value shows more disability from PD.
Time Frame Baseline to 36 months of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) population. One participant had missing baseline UPDRS sections while had finished baseline Levodopa Cumulative. So Levodopa Cumulative had 1 observation more than primary outcomes.
Arm/Group Title Isradipine Placebo (for Isradipine)
Hide Arm/Group Description:
Receive Isradipine 5 mg twice daily for 36 months. Isradipine: oral immediate-release capsule of Isradipine 10 mg per day.
Receive placebo twice daily for 36 months. Placebo: Sugar Pill manufactured to look like Isradipine but has no active ingredients
Overall Number of Participants Analyzed 162 159
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mg
471
(388 to 555)
508
(426 to 590)
25.Other Pre-specified Outcome
Title Adjusted Mean Change in Systolic BP, Seated
Hide Description Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the Systolic BP, Seated in the active treatment arm versus placebo between the baseline and 36 month visit. The change in Systolic BP, Seated ranges from -65 to 50. larger value shows worsening of conditions.
Time Frame Baseline to 36 months of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) population. One participant had missing baseline UPDRS sections while had finished baseline Systolic BP, Seated. So Systolic BP had 1 observation more than primary outcomes.
Arm/Group Title Isradipine Placebo (for Isradipine)
Hide Arm/Group Description:
Receive Isradipine 5 mg twice daily for 36 months. Isradipine: oral immediate-release capsule of Isradipine 10 mg per day.
Receive placebo twice daily for 36 months. Placebo: Sugar Pill manufactured to look like Isradipine but has no active ingredients
Overall Number of Participants Analyzed 162 159
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mmHg
-6.11
(-8.28 to -3.95)
1.03
(-1.10 to 3.15)
26.Other Pre-specified Outcome
Title Adjusted Mean Change in Diastolic BP, Seated
Hide Description Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the Diastolic BP, Seated in the active treatment arm versus placebo between the baseline and 36 month visit. The change in Diastolic BP, Seated ranges from -35 to 25. larger value shows worsening of conditions.
Time Frame Baseline to 36 months of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) population. One participant had missing baseline UPDRS sections while had finished baseline Diastolic BP, Seated. So Diastolic BP had 1 observation more than primary outcomes.
Arm/Group Title Isradipine Placebo (for Isradipine)
Hide Arm/Group Description:
Receive Isradipine 5 mg twice daily for 36 months. Isradipine: oral immediate-release capsule of Isradipine 10 mg per day.
Receive placebo twice daily for 36 months. Placebo: Sugar Pill manufactured to look like Isradipine but has no active ingredients
Overall Number of Participants Analyzed 162 159
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mmHg
-4.64
(-5.93 to -3.36)
-0.71
(-1.96 to 0.55)
Time Frame Baseline to 36 months of treatment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Isradipine Placebo (for Isradipine)
Hide Arm/Group Description

Oral capsule of up to 5 mg of isradipine taken twice daily for 36 months.

Isradipine: Oral capsules Isradipine IR, up to 10 mg, taken twice daily

Oral capsule taken twice daily for 36 months.

Placebo (for Isradipine): Sugar Pill manufactured to look like Isradipine but has no active ingredients

All-Cause Mortality
Isradipine Placebo (for Isradipine)
Affected / at Risk (%) Affected / at Risk (%)
Total   2/170 (1.18%)      1/166 (0.60%)    
Hide Serious Adverse Events
Isradipine Placebo (for Isradipine)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   26/170 (15.29%)      27/166 (16.27%)    
Cardiac disorders     
BRADYCARDIA   1/170 (0.59%)  1 0/166 (0.00%)  0
MYOCARDIAL INFARCTION   0/170 (0.00%)  0 1/166 (0.60%)  1
STRESS CARDIOMYOPATHY   0/170 (0.00%)  0 1/166 (0.60%)  1
Congenital, familial and genetic disorders     
SPINA BIFIDA   1/170 (0.59%)  1 0/166 (0.00%)  0
Gastrointestinal disorders     
GASTROINTESTINAL HAEMORRHAGE   1/170 (0.59%)  1 1/166 (0.60%)  1
APPENDICEAL MUCOCOELE   1/170 (0.59%)  1 0/166 (0.00%)  0
DYSPHAGIA   0/170 (0.00%)  0 1/166 (0.60%)  1
SMALL INTESTINAL OBSTRUCTION   1/170 (0.59%)  1 0/166 (0.00%)  0
General disorders     
CHEST DISCOMFORT   1/170 (0.59%)  1 0/166 (0.00%)  0
Infections and infestations     
SEPSIS   2/170 (1.18%)  2 0/166 (0.00%)  0
APPENDICITIS   0/170 (0.00%)  0 1/166 (0.60%)  1
APPENDICITIS PERFORATED   0/170 (0.00%)  0 1/166 (0.60%)  1
BRONCHIOLITIS   0/170 (0.00%)  0 1/166 (0.60%)  1
GASTROENTERITIS VIRAL   1/170 (0.59%)  1 0/166 (0.00%)  0
MENINGITIS   0/170 (0.00%)  0 1/166 (0.60%)  1
PNEUMONIA   0/170 (0.00%)  0 1/166 (0.60%)  1
PYELONEPHRITIS ACUTE   0/170 (0.00%)  0 1/166 (0.60%)  1
URINARY TRACT INFECTION   1/170 (0.59%)  1 0/166 (0.00%)  0
Injury, poisoning and procedural complications     
STRESS FRACTURE   2/170 (1.18%)  2 0/166 (0.00%)  0
UPPER LIMB FRACTURE   1/170 (0.59%)  1 1/166 (0.60%)  1
HUMERUS FRACTURE   0/170 (0.00%)  0 1/166 (0.60%)  1
SPINAL FRACTURE   1/170 (0.59%)  1 0/166 (0.00%)  0
WRIST FRACTURE   0/170 (0.00%)  0 1/166 (0.60%)  1
Metabolism and nutrition disorders     
DEHYDRATION   0/170 (0.00%)  0 1/166 (0.60%)  1
Musculoskeletal and connective tissue disorders     
OSTEOARTHRITIS   3/170 (1.76%)  4 1/166 (0.60%)  1
ARTHRITIS   1/170 (0.59%)  1 1/166 (0.60%)  1
BACK PAIN   1/170 (0.59%)  1 1/166 (0.60%)  1
ARTHRALGIA   0/170 (0.00%)  0 1/166 (0.60%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
COLON CANCER   2/170 (1.18%)  2 0/166 (0.00%)  0
PROSTATE CANCER   2/170 (1.18%)  2 0/166 (0.00%)  0
B-CELL LYMPHOMA   0/170 (0.00%)  0 1/166 (0.60%)  1
BREAST CANCER   0/170 (0.00%)  0 1/166 (0.60%)  1
CHOROID MELANOMA   1/170 (0.59%)  1 0/166 (0.00%)  0
METASTATIC SQUAMOUS CELL CARCINOMA   0/170 (0.00%)  0 1/166 (0.60%)  1
PANCREATIC NEOPLASM   1/170 (0.59%)  1 0/166 (0.00%)  0
PITUITARY TUMOUR   0/170 (0.00%)  0 1/166 (0.60%)  1
RECTAL CANCER   0/170 (0.00%)  0 1/166 (0.60%)  1
SQUAMOUS CELL CARCINOMA   0/170 (0.00%)  0 1/166 (0.60%)  1
THROAT CANCER   1/170 (0.59%)  1 0/166 (0.00%)  0
Nervous system disorders     
SYNCOPE   1/170 (0.59%)  1 1/166 (0.60%)  1
TRANSIENT ISCHAEMIC ATTACK   2/170 (1.18%)  2 0/166 (0.00%)  0
APHASIA   0/170 (0.00%)  0 1/166 (0.60%)  1
BASAL GANGLIA HAEMORRHAGE   0/170 (0.00%)  0 1/166 (0.60%)  1
CEREBROVASCULAR ACCIDENT   0/170 (0.00%)  0 1/166 (0.60%)  1
HYPERTENSIVE ENCEPHALOPATHY   0/170 (0.00%)  0 1/166 (0.60%)  1
INTRAVENTRICULAR HAEMORRHAGE   1/170 (0.59%)  1 0/166 (0.00%)  0
ISCHAEMIC STROKE   1/170 (0.59%)  1 0/166 (0.00%)  0
Psychiatric disorders     
HALLUCINATION, VISUAL   0/170 (0.00%)  0 1/166 (0.60%)  1
SUICIDAL IDEATION   0/170 (0.00%)  0 1/166 (0.60%)  1
Renal and urinary disorders     
NEPHROLITHIASIS   1/170 (0.59%)  1 0/166 (0.00%)  0
URINARY RETENTION   1/170 (0.59%)  1 0/166 (0.00%)  0
Reproductive system and breast disorders     
MENORRHAGIA   0/170 (0.00%)  0 1/166 (0.60%)  1
Respiratory, thoracic and mediastinal disorders     
DYSPNOEA   1/170 (0.59%)  1 0/166 (0.00%)  0
PNEUMONIA ASPIRATION   1/170 (0.59%)  1 0/166 (0.00%)  0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Isradipine Placebo (for Isradipine)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   163/170 (95.88%)      154/166 (92.77%)    
Blood and lymphatic system disorders     
LYMPHOPENIA   0/170 (0.00%)  0 4/166 (2.41%)  5
ANAEMIA   2/170 (1.18%)  2 2/166 (1.20%)  2
Cardiac disorders     
PALPITATIONS   6/170 (3.53%)  6 2/166 (1.20%)  2
TACHYCARDIA   4/170 (2.35%)  5 2/166 (1.20%)  2
ATRIOVENTRICULAR BLOCK FIRST DEGREE   3/170 (1.76%)  3 2/166 (1.20%)  2
ATRIAL FIBRILLATION   2/170 (1.18%)  2 2/166 (1.20%)  2
Ear and labyrinth disorders     
VERTIGO   2/170 (1.18%)  3 5/166 (3.01%)  6
EAR DISCOMFORT   3/170 (1.76%)  3 1/166 (0.60%)  1
Eye disorders     
CATARACT   4/170 (2.35%)  6 7/166 (4.22%)  9
VISION BLURRED   7/170 (4.12%)  8 2/166 (1.20%)  2
DRY EYE   3/170 (1.76%)  3 4/166 (2.41%)  4
Gastrointestinal disorders     
NAUSEA   26/170 (15.29%)  29 32/166 (19.28%)  38
CONSTIPATION   23/170 (13.53%)  24 21/166 (12.65%)  22
GASTROOESOPHAGEAL REFLUX DISEASE   5/170 (2.94%)  6 9/166 (5.42%)  11
DIARRHOEA   7/170 (4.12%)  11 5/166 (3.01%)  5
DYSPHAGIA   7/170 (4.12%)  9 4/166 (2.41%)  6
ABDOMINAL PAIN UPPER   6/170 (3.53%)  7 4/166 (2.41%)  4
DYSPEPSIA   4/170 (2.35%)  4 4/166 (2.41%)  4
INGUINAL HERNIA   4/170 (2.35%)  4 4/166 (2.41%)  4
VOMITING   3/170 (1.76%)  3 4/166 (2.41%)  4
ABDOMINAL PAIN   3/170 (1.76%)  4 3/166 (1.81%)  3
ABDOMINAL DISTENSION   3/170 (1.76%)  3 3/166 (1.81%)  3
DRY MOUTH   3/170 (1.76%)  3 1/166 (0.60%)  1
SALIVARY HYPERSECRETION   3/170 (1.76%)  3 1/166 (0.60%)  1
General disorders     
OEDEMA   31/170 (18.24%)  41 9/166 (5.42%)  11
FATIGUE   23/170 (13.53%)  28 20/166 (12.05%)  21
CHEST PAIN   6/170 (3.53%)  7 5/166 (3.01%)  5
PAIN   5/170 (2.94%)  5 2/166 (1.20%)  2
IRRITABILITY   2/170 (1.18%)  3 3/166 (1.81%)  3
ASTHENIA   2/170 (1.18%)  2 2/166 (1.20%)  2
Infections and infestations     
NASOPHARYNGITIS   23/170 (13.53%)  26 22/166 (13.25%)  23
UPPER RESPIRATORY TRACT INFECTION   12/170 (7.06%)  13 11/166 (6.63%)  20
SINUSITIS   7/170 (4.12%)  8 13/166 (7.83%)  17
BRONCHITIS   5/170 (2.94%)  5 11/166 (6.63%)  12
URINARY TRACT INFECTION   5/170 (2.94%)  5 8/166 (4.82%)  9
INFLUENZA   3/170 (1.76%)  3 8/166 (4.82%)  8
DIVERTICULITIS   5/170 (2.94%)  6 1/166 (0.60%)  5
TOOTH ABSCESS   4/170 (2.35%)  4 2/166 (1.20%)  2
RESPIRATORY TRACT INFECTION   3/170 (1.76%)  3 2/166 (1.20%)  3
EYE INFECTION   3/170 (1.76%)  3 2/166 (1.20%)  2
HERPES ZOSTER   2/170 (1.18%)  2 3/166 (1.81%)  3
LOWER RESPIRATORY TRACT INFECTION   3/170 (1.76%)  3 2/166 (1.20%)  2
PNEUMONIA   1/170 (0.59%)  1 3/166 (1.81%)  4
TOOTH INFECTION   0/170 (0.00%)  0 4/166 (2.41%)  4
Injury, poisoning and procedural complications     
FALL   7/170 (4.12%)  10 15/166 (9.04%)  20
LACERATION   5/170 (2.94%)  5 5/166 (3.01%)  5
MUSCLE STRAIN   6/170 (3.53%)  6 3/166 (1.81%)  3
LIGAMENT SPRAIN   2/170 (1.18%)  3 4/166 (2.41%)  4
CONTUSION   2/170 (1.18%)  3 3/166 (1.81%)  3
WRIST FRACTURE   1/170 (0.59%)  1 3/166 (1.81%)  3
Investigations     
BLOOD CREATINE PHOSPHOKINASE INCREASED   6/170 (3.53%)  6 3/166 (1.81%)  3
BLOOD CREATININE INCREASED   7/170 (4.12%)  7 2/166 (1.20%)  2
Metabolism and nutrition disorders     
ABNORMAL LOSS OF WEIGHT   4/170 (2.35%)  4 5/166 (3.01%)  5
DECREASED APPETITE   3/170 (1.76%)  3 3/166 (1.81%)  3
VITAMIN D DEFICIENCY   4/170 (2.35%)  4 2/166 (1.20%)  2
HYPERGLYCAEMIA   2/170 (1.18%)  2 2/166 (1.20%)  2
Musculoskeletal and connective tissue disorders     
ARTHRALGIA   17/170 (10.00%)  19 20/166 (12.05%)  26
BACK PAIN   17/170 (10.00%)  20 15/166 (9.04%)  16
MUSCULOSKELETAL PAIN   12/170 (7.06%)  14 15/166 (9.04%)  15
MUSCLE SPASMS   11/170 (6.47%)  12 13/166 (7.83%)  15
PAIN IN EXTREMITY   11/170 (6.47%)  14 9/166 (5.42%)  11
JOINT SWELLING   12/170 (7.06%)  13 7/166 (4.22%)  8
MUSCULOSKELETAL STIFFNESS   8/170 (4.71%)  9 6/166 (3.61%)  9
OSTEOARTHRITIS   7/170 (4.12%)  8 6/166 (3.61%)  6
TENDONITIS   7/170 (4.12%)  8 5/166 (3.01%)  5
MYALGIA   6/170 (3.53%)  6 6/166 (3.61%)  6
PLANTAR FASCIITIS   2/170 (1.18%)  2 5/166 (3.01%)  5
BURSITIS   0/170 (0.00%)  0 6/166 (3.61%)  6
NECK PAIN   0/170 (0.00%)  0 6/166 (3.61%)  6
ROTATOR CUFF SYNDROME   5/170 (2.94%)  6 0/166 (0.00%)  0
OSTEOPOROSIS   3/170 (1.76%)  3 2/166 (1.20%)  2
MUSCULAR WEAKNESS   3/170 (1.76%)  3 1/166 (0.60%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
BASAL CELL CARCINOMA   6/170 (3.53%)  7 5/166 (3.01%)  8
SQUAMOUS CELL CARCINOMA   3/170 (1.76%)  3 3/166 (1.81%)  3
Nervous system disorders     
DIZZINESS   42/170 (24.71%)  55 26/166 (15.66%)  30
HEADACHE   28/170 (16.47%)  40 17/166 (10.24%)  19
SOMNOLENCE   10/170 (5.88%)  11 8/166 (4.82%)  9
HYPOAESTHESIA   8/170 (4.71%)  11 6/166 (3.61%)  8
TREMOR   5/170 (2.94%)  5 9/166 (5.42%)  9
DYSTONIA   8/170 (4.71%)  8 4/166 (2.41%)  5
PARAESTHESIA   5/170 (2.94%)  5 4/166 (2.41%)  5
SCIATICA   4/170 (2.35%)  6 3/166 (1.81%)  3
RESTLESS LEGS SYNDROME   3/170 (1.76%)  3 5/166 (3.01%)  5
BRADYKINESIA   3/170 (1.76%)  3 4/166 (2.41%)  4
AMNESIA   3/170 (1.76%)  3 3/166 (1.81%)  3
SYNCOPE   4/170 (2.35%)  4 2/166 (1.20%)  2
COGNITIVE DISORDER   2/170 (1.18%)  2 3/166 (1.81%)  3
MEMORY IMPAIRMENT   1/170 (0.59%)  1 3/166 (1.81%)  3
Psychiatric disorders     
INSOMNIA   19/170 (11.18%)  22 19/166 (11.45%)  20
ANXIETY   20/170 (11.76%)  22 13/166 (7.83%)  16
DEPRESSION   20/170 (11.76%)  22 13/166 (7.83%)  14
SLEEP DISORDER   9/170 (5.29%)  9 8/166 (4.82%)  8
RAPID EYE MOVEMENTS SLEEP ABNORMAL   7/170 (4.12%)  8 6/166 (3.61%)  6
HALLUCINATION   1/170 (0.59%)  1 6/166 (3.61%)  6
SUICIDAL IDEATION   3/170 (1.76%)  4 1/166 (0.60%)  2
ABNORMAL DREAMS   3/170 (1.76%)  3 2/166 (1.20%)  2
CONFUSIONAL STATE   5/170 (2.94%)  5 0/166 (0.00%)  0
Renal and urinary disorders     
POLLAKIURIA   7/170 (4.12%)  7 7/166 (4.22%)  7
NEPHROLITHIASIS   5/170 (2.94%)  9 4/166 (2.41%)  4
MICTURITION URGENCY   7/170 (4.12%)  8 3/166 (1.81%)  3
PROTEINURIA   2/170 (1.18%)  2 5/166 (3.01%)  5
URINARY INCONTINENCE   3/170 (1.76%)  3 2/166 (1.20%)  2
HAEMATURIA   0/170 (0.00%)  0 4/166 (2.41%)  4
Reproductive system and breast disorders     
ERECTILE DYSFUNCTION   7/170 (4.12%)  7 2/166 (1.20%)  2
BENIGN PROSTATIC HYPERPLASIA   5/170 (2.94%)  5 3/166 (1.81%)  3
Respiratory, thoracic and mediastinal disorders     
COUGH   9/170 (5.29%)  11 9/166 (5.42%)  11
DYSPNOEA   9/170 (5.29%)  9 4/166 (2.41%)  4
PULMONARY MASS   2/170 (1.18%)  2 3/166 (1.81%)  4
RHINORRHOEA   3/170 (1.76%)  3 2/166 (1.20%)  2
EPISTAXIS   1/170 (0.59%)  1 3/166 (1.81%)  4
NASAL CONGESTION   3/170 (1.76%)  3 1/166 (0.60%)  1
Skin and subcutaneous tissue disorders     
RASH   6/170 (3.53%)  6 7/166 (4.22%)  7
ALOPECIA   3/170 (1.76%)  3 3/166 (1.81%)  3
ERYTHEMA   1/170 (0.59%)  1 3/166 (1.81%)  3
Vascular disorders     
HYPERTENSION   8/170 (4.71%)  8 8/166 (4.82%)  8
ORTHOSTATIC HYPOTENSION   5/170 (2.94%)  6 6/166 (3.61%)  6
HYPOTENSION   4/170 (2.35%)  4 5/166 (3.01%)  6
FLUSHING   7/170 (4.12%)  8 0/166 (0.00%)  0
HOT FLUSH   5/170 (2.94%)  6 1/166 (0.60%)  1
DEEP VEIN THROMBOSIS   2/170 (1.18%)  2 2/166 (1.20%)  3
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: David Oakes, PhD
Organization: University of Rochester Medical Center, Department of Biostatistics and Computational Biology
Phone: 5852752405
EMail: david_oakes@urmc.rochester.edu
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Robert Holloway, University of Rochester
ClinicalTrials.gov Identifier: NCT02168842    
Other Study ID Numbers: STEADY-PD III
U01NS080818-01A1 ( U.S. NIH Grant/Contract )
U01NS080840-01A1 ( U.S. NIH Grant/Contract )
First Submitted: June 18, 2014
First Posted: June 20, 2014
Results First Submitted: December 6, 2019
Results First Posted: January 14, 2020
Last Update Posted: January 14, 2020