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Safety, Tolerability and Efficacy Assessment of Dynacirc CR in Parkinson Disease (STEADY-PD)

This study has been completed.
Sponsor:
Collaborators:
Michael J. Fox Foundation for Parkinson's Research
Northwestern University Dixon Fund
The Parkinson Study Group
Information provided by (Responsible Party):
Tanya Simuni, Northwestern University
ClinicalTrials.gov Identifier:
NCT00909545
First received: May 26, 2009
Last updated: April 16, 2013
Last verified: April 2013
Results First Received: October 2, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Parkinson Disease
Interventions: Drug: Isradipine CR 5mg
Drug: Isradipine CR 10mg
Drug: Isradipine CR 20mg
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Placebo 4 Placebo to Match (PTM) tablets once daily
Isradipine CR 5mg/Day 1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
Isradipine CR 10mg/Day 2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
Isradipine CR 15-20mg/Day 3-4 Dynacirc CR 5mg tablets once daily

Participant Flow:   Overall Study
    Placebo   Isradipine CR 5mg/Day   Isradipine CR 10mg/Day   Isradipine CR 15-20mg/Day
STARTED   26   23   26   24 
COMPLETED   25   22   25   19 
NOT COMPLETED   1   1   1   5 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Placebo 4 Placebo to Match (PTM) tablets once daily
Isradipine CR 5mg/Day 1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
Isradipine CR 10mg/Day 2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
Isradipine CR 20mg/Day 4 Dynacirc CR 5mg tablets once daily
Total Total of all reporting groups

Baseline Measures
   Placebo   Isradipine CR 5mg/Day   Isradipine CR 10mg/Day   Isradipine CR 20mg/Day   Total 
Overall Participants Analyzed 
[Units: Participants]
 26   23   26   24   99 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.2  (10.1)   57.7  (8.3)   58.5  (11.6)   59.8  (8.9)   59.1  (9.8) 
Age, Customized 
[Units: Participants]
         
Between 30 and 65 years   17   18   18   19   72 
>=65 years   9   5   8   5   27 
Gender 
[Units: Participants]
         
Female   5   8   9   8   30 
Male   21   15   17   16   69 
Race/Ethnicity, Customized 
[Units: Participants]
         
White   25   22   22   22   91 
Other race   1   1   4   2   8 
Region of Enrollment 
[Units: Participants]
         
United States   24   21   24   21   90 
Canada   2   2   2   3   9 
Unified Parkinson's Disease Rating Scale (UPDRS) Total [1] 
[Units: Unit of UPDRS scales]
Mean (Standard Deviation)
 25.46  (9.39)   26.43  (9.69)   23.65  (9.97)   24.67  (10.77)   25.0  (9.9) 
[1] Higher score indicates more severe disability.
Unified Parkinson's Disease Rating Scale (UPDRS) Mental [1] 
[Units: Unit of UPDRS scales]
Mean (Standard Deviation)
 0.65  (1.06)   1.30  (1.79)   0.65  (0.98)   0.96  (1.12)   0.9  (1.3) 
[1] Higher score indicates more severe disability.
Unified Parkinson's Disease Rating Scale (UPDRS) Activities of Daily Living (ADL) [1] 
[Units: Unit of UPDRS scales]
Mean (Standard Deviation)
 5.85  (2.98)   5.83  (3.02)   6.15  (3.03)   6.58  (3.03)   6.1  (3.0) 
[1] Higher score indicates more severe disability.
Unified Parkinson's Disease Rating Scale (UPDRS) Motor [1] 
[Units: Unit of UPDRS scales]
Mean (Standard Deviation)
 18.96  (7.27)   19.30  (8.02)   16.85  (7.88)   17.13  (8.26)   18.0  (7.8) 
[1] Higher score indicates more severe disability.
Hoehn & Yahr Scale [1] 
[Units: Participants]
         
H/Y Stage: 1   7   4   8   11   30 
H/Y Stage: 1.5   2   3   0   1   6 
H/Y Stage: 2   16   16   18   11   61 
H/Y Stage: 2.5   1   0   0   1   2 
[1] Higher stage indicates more severe disability.
Modified Schwab & England Independence Scale [1] 
[Units: Percentage scale]
Mean (Standard Deviation)
 93.08  (5.11)   93.48  (4.632)   93.08  (5.11)   91.04  (5.10)   92.0  (5.0) 
[1] Higher score indicates higher independence.
Montreal Cognitive Assessment [1] 
[Units: Unit of MoCA]
Mean (Standard Deviation)
 26.96  (2.58)   27.96  (1.97)   26.92  (2.36)   27.79  (1.89)   27.4  (2.2) 
[1] Lower score indicates more severe disability.
PD Qualify of Life Scale [1] 
[Units: Unit of PDQ-39]
Mean (Standard Deviation)
 10.28  (8.55)   9.69  (6.88)   8.39  (5.82)   10.45  (8.06)   9.7  (2.3) 
[1] Higher score indicates higher disability.
Vital Signs: Systolic 
[Units: Mm Hg]
Mean (Standard Deviation)
         
Standing   130.0  (18.12)   127.3  (17.03)   130.4  (17.76)   125.8  (11.96)   128.4  (16.3) 
Supine   130.9  (16.04)   128.5  (13.60)   131.3  (19.00)   129.1  (13.69)   130.0  (15.6) 
Vital Signs: Diastolic 
[Units: Mm Hg]
Mean (Standard Deviation)
         
Standing   83.73  (12.74)   84.43  (12.22)   80.04  (9.73)   81.29  (11.02)   82.3  (11.4) 
Supine   80.69  (11.34)   79.22  (9.50)   76.88  (10.95)   79.63  (10.43)   79.1  (10.5) 
Vital Signs: Pulse 
[Units: Beats per minute]
Mean (Standard Deviation)
         
Standing   72.92  (11.90)   77.35  (10.70)   75.50  (12.27)   72.33  (11.43)   74.5  (11.6) 
Supine   68.00  (10.63)   67.43  (10.28)   67.08  (8.39)   66.33  (9.71)   67.2  (9.6) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Tolerability of the Three Dosages(5mg, 10mg and 20mg) of Isradipine CR.   [ Time Frame: Baseline to 12 months or the time to require dopaminergic therapy ]

2.  Secondary:   Efficacy: Change in Unified Parkinson's Disease Rating Scale (UPDRS)   [ Time Frame: Baseline to 12 months or the time to require dopaminergic therapy ]

3.  Secondary:   Efficacy: Change in Mental Subscales of the Unified Parkinson's Disease Rating Scale   [ Time Frame: Baseline to 12 months or the time to require dopaminergic therapy ]

4.  Secondary:   Efficacy: Change in Activities of Daily Living(ADL) Subscale of the Unified Parkinson's Disease Rating Scale   [ Time Frame: Baseline to 12 months or the time to require dopaminergic therapy ]

5.  Secondary:   Efficacy: Change in Motor Subscale of the Unified Parkinson's Disease Rating Scale   [ Time Frame: Baseline to 12 months or the time to require dopaminergic therapy ]

6.  Secondary:   Efficacy: Change in Modified Hoehn & Yahr Scale   [ Time Frame: Baseline to 12 months or the time to require dopaminergic therapy ]

7.  Secondary:   Efficacy: Change in Modified Schwab & England Independence Scale   [ Time Frame: Baseline to 12 months or the time to require dopaminergic therapy ]

8.  Secondary:   Efficacy: Change in Beck Depression Inventory II (BDI-II)   [ Time Frame: Baseline to 12 months or the time to require dopaminergic therapy ]

9.  Secondary:   Efficacy: Change in Montreal Cognitive Assessment   [ Time Frame: Baseline to 12 months or the time to require dopaminergic therapy ]

10.  Secondary:   Efficacy: Change in Parkinson Disease Quality of Life Questionnaire-39(PDQ-39)   [ Time Frame: Baseline to 12 months or the time to require dopaminergic therapy ]

11.  Secondary:   Vital Signs: Change in Systolic Standing   [ Time Frame: Baseline to 12 months or the time to require dopaminergic therapy ]

12.  Secondary:   Vital Signs: Change in Systolic Supine   [ Time Frame: Baseline to 12 months or the time to require dopaminergic therapy ]

13.  Secondary:   Vital Signs: Change in Diastolic Standing   [ Time Frame: Baseline to 12 months or the time to require dopaminergic therapy ]

14.  Secondary:   Vital Signs: Change in Diastolic Supine   [ Time Frame: Baseline to 12 months or the time to require dopaminergic therapy ]

15.  Secondary:   Vital Signs: Change in Pulse Standing   [ Time Frame: Baseline to 12 months or the time to require dopaminergic therapy ]

16.  Secondary:   Vital Signs: Change in Pulse Supine   [ Time Frame: Baseline to 12 months or the time to require dopaminergic therapy ]

17.  Secondary:   Common Adverse Events: Oedema Peripheral   [ Time Frame: Baseline to 12 months or the time to require dopaminergic therapy ]

18.  Secondary:   Common Adverse Events: Dizziness   [ Time Frame: Baseline to 12 months or the time to require dopaminergic therapy ]

19.  Secondary:   Common Adverse Events: Nasopharyngitis   [ Time Frame: Baseline to 12 months or the time to require dopaminergic therapy ]

20.  Secondary:   Common Adverse Events: Headache   [ Time Frame: Baseline to 12 months or the time to require dopaminergic therapy ]

21.  Secondary:   Common Adverse Events: Constipation   [ Time Frame: Baseline to 12 months or the time to require dopaminergic therapy ]

22.  Secondary:   Common Adverse Events: Fatigue   [ Time Frame: Baseline to 12 months or the time to require dopaminergic therapy ]

23.  Secondary:   Common Adverse Events: Nausea   [ Time Frame: Baseline to 12 months or the time to require dopaminergic therapy ]

24.  Secondary:   Common Adverse Events: Upper Respiratory Tract Infection   [ Time Frame: Baseline to 12 months or the time to require dopaminergic therapy ]

25.  Secondary:   Common Adverse Events: Depression   [ Time Frame: Baseline to 12 months or the time to require dopaminergic therapy ]

26.  Secondary:   Common Adverse Events: Somnolence   [ Time Frame: Baseline to 12 months or the time to require dopaminergic therapy ]

27.  Secondary:   Common Adverse Events: Insomnia   [ Time Frame: Baseline to 12 months or the time to require dopaminergic therapy ]

28.  Secondary:   Common Adverse Events: Dyspepsia   [ Time Frame: Baseline to 12 months or the time to require dopaminergic therapy ]

29.  Secondary:   Common Adverse Events: Diarrhoea   [ Time Frame: Baseline to 12 months or the time to require dopaminergic therapy ]

30.  Secondary:   Common Adverse Events: Sinusitis   [ Time Frame: Baseline to 12 months or the time to require dopaminergic therapy ]

31.  Secondary:   Common Adverse Events: Back Pain   [ Time Frame: Baseline to 12 months or the time to require dopaminergic therapy ]

32.  Secondary:   Common Adverse Events: Hypotension   [ Time Frame: Baseline to 12 months or the time to require dopaminergic therapy ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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:  
Name/Title: Tanya Simuni, MD
Organization: Feinberg School of Medicine, Northwestern University
phone: 312-503-2970
e-mail: TSimuni@nmff.org


Publications:


Responsible Party: Tanya Simuni, Northwestern University
ClinicalTrials.gov Identifier: NCT00909545     History of Changes
Other Study ID Numbers: CTCC Protocol #124
Study First Received: May 26, 2009
Results First Received: October 2, 2012
Last Updated: April 16, 2013
Health Authority: United States: Institutional Review Board
Canada: Health Canada