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Safety of Urate Elevation in Parkinson's Disease (SURE-PD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00833690
First Posted: February 2, 2009
Last Update Posted: June 5, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Massachusetts General Hospital
Harvard School of Public Health
University of Rochester
Michael J. Fox Foundation for Parkinson's Research
Information provided by (Responsible Party):
Michael Schwarzschild, The Parkinson Study Group
Results First Submitted: December 26, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Parkinson Disease
Interventions: Drug: Placebo
Drug: inosine

  Participant Flow
  Hide Participant Flow

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
[A:]Placebo Placebo to produce no urate elevation
[B:]Mild Inosine to produce a mild urate elevation
[C.]Moderate Inosine to produce a moderate urate elevation

Participant Flow:   Overall Study
    [A:]Placebo   [B:]Mild   [C.]Moderate
STARTED   25   24   26 
COMPLETED   21   22   26 
NOT COMPLETED   4   2   0 
Withdrawal by Subject                1                0                0 
Discontinued study drug                3                2                0 



  Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Tolerability   [ Time Frame: 6 months ]

2.  Primary:   Tolerability   [ Time Frame: 24 months ]

3.  Primary:   Safety   [ Time Frame: 24 months ]

4.  Secondary:   CSF Urate (All Patients)   [ Time Frame: 12 weeks ]

5.  Secondary:   CSF Urate (Females)   [ Time Frame: 12 weeks ]

6.  Secondary:   CSF Urate (Males)   [ Time Frame: 12 weeks ]

7.  Secondary:   CSF Urate as a Proportion of Baseline Serum Urate (All Patients)   [ Time Frame: 12 weeks ]

8.  Secondary:   CSF Urate as a Proportion of Baseline Serum Urate (Females)   [ Time Frame: 12 weeks ]

9.  Secondary:   CSF Urate as a Proportion of Baseline Serum Urate (Males)   [ Time Frame: 12 weeks ]

10.  Secondary:   Serum Urate   [ Time Frame: Screening Visits, up to 45 days prior to Baseline Visit. Specifically, Screening Visit 1 occurred between day -45 and -4; Screening Visit 2 occurred between day -43 and -2. ]

11.  Secondary:   Serum Urate   [ Time Frame: Baseline Visit ]

12.  Secondary:   Serum Urate   [ Time Frame: Visit 01 (Week 2; 14 +/- 3 days after Baseline Visit) ]

13.  Secondary:   Serum Urate   [ Time Frame: Visit 02 (Week 4; 28 +/- 3 days after Baseline Visit) ]

14.  Secondary:   Serum Urate   [ Time Frame: Visit 03 (Week 6; 42 +/- 3 days after Baseline Visit) ]

15.  Secondary:   Serum Urate   [ Time Frame: Visit 04 (Week 9; 63 +/- 5 days after Baseline Visit) ]

16.  Secondary:   Serum Urate   [ Time Frame: Visit 05 (Week 12; 84 +/- 7 days after Baseline Visit) ]

17.  Secondary:   Serum Urate   [ Time Frame: Visit 06 (Month 6; 180 +/- 7 days after Baseline Visit) ]

18.  Secondary:   Serum Urate   [ Time Frame: Visit 07 (Month 9; 270 +/- 7 days after Baseline Visit) ]

19.  Secondary:   Serum Urate   [ Time Frame: Visit 08 (Month 12; 360 +/- 7 days after Baseline Visit) ]

20.  Secondary:   Serum Urate   [ Time Frame: Visit 09 (Month 15; 450 +/- 7 days after Baseline Visit) ]

21.  Secondary:   Serum Urate   [ Time Frame: Visit 10 (Month 18; 540 +/- 7 days after Baseline Visit) ]

22.  Secondary:   Serum Urate   [ Time Frame: Visit 11 (Month 21; 630 +/- 7 days after Baseline Visit) ]

23.  Secondary:   Serum Urate   [ Time Frame: Visit 12 (Month 24; 720 +/- 7 days after Baseline Visit) ]

24.  Secondary:   Serum Urate   [ Time Frame: End of Study Drug Visit (ESD) (Month 9-24; 263-727 days after Baseline Visit) ]

25.  Secondary:   Serum Urate   [ Time Frame: Safety Visit (SV); 30 +/- 3 days following ESD or Month 24 Visit ]

26.  Secondary:   Change in Serum Urate   [ Time Frame: Visit 01 from Baseline (i.e., between -45 days and +2 weeks) ]

27.  Secondary:   Change in Serum Urate   [ Time Frame: Visit 02 from Baseline (i.e., between -45 days and +4 weeks) ]

28.  Secondary:   Change in Serum Urate   [ Time Frame: Visit 03 from Baseline (i.e., between -45 days and +6 weeks) ]

29.  Secondary:   Change in Serum Urate   [ Time Frame: Visit 04 from Baseline (i.e., between -45 days and +9 weeks) ]

30.  Secondary:   Change in Serum Urate   [ Time Frame: Visit 05 from Baseline (i.e., between -45 days and +12 weeks) ]

31.  Secondary:   Change in Serum Urate   [ Time Frame: Visit 06 from Baseline (i.e., between -45 days and +6 months) ]

32.  Secondary:   Change in Serum Urate   [ Time Frame: Visit 07 from Baseline (i.e., between -45 days and +9 months) ]

33.  Secondary:   Change in Serum Urate   [ Time Frame: Visit 08 from Baseline (i.e., between -45 days and +12 months) ]

34.  Secondary:   Change in Serum Urate   [ Time Frame: Visit 09 from Baseline (i.e., between -45 days and +15 months) ]

35.  Secondary:   Change in Serum Urate   [ Time Frame: Visit 10 from Baseline (i.e., between -45 days and +18 months) ]

36.  Secondary:   Change in Serum Urate   [ Time Frame: Visit 11 from Baseline (i.e., between -45 days and +21 months) ]

37.  Secondary:   Change in Serum Urate   [ Time Frame: Visit 12 from Baseline (i.e., between -45 days and +24 months) ]

38.  Secondary:   Change in Serum Urate   [ Time Frame: Safety Visit (SV) from Baseline (i.e., between -45 days and +760 days [+1 month after ESD Visit]) ]

39.  Secondary:   Change in Serum Urate   [ Time Frame: Safety Visit (SV) from End of Study Drug Visit (ESD); i.e., between +263 and +760 days) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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: Michael A. Schwarzschild, MD, PhD
Organization: The Parkinson Study Group
phone: 617-724-9611
e-mail: mschwarzschild@partners.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Michael Schwarzschild, The Parkinson Study Group
ClinicalTrials.gov Identifier: NCT00833690     History of Changes
Other Study ID Numbers: INO-PD-P2-2008
First Submitted: January 27, 2009
First Posted: February 2, 2009
Results First Submitted: December 26, 2013
Results First Posted: June 5, 2014
Last Update Posted: June 5, 2014



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