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

This study has been completed.
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT00833690
First received: January 27, 2009
Last updated: May 30, 2014
Last verified: May 2014
Results First Received: December 26, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Parkinson Disease
Interventions: Drug: Placebo
Drug: inosine

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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
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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.
No text entered.

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
Total Total of all reporting groups

Baseline Measures
   [A:]Placebo   [B:]Mild   [C.]Moderate   Total 
Overall Participants Analyzed 
[Units: Participants]
 25   24   26   75 
Age 
[Units: Years]
Mean (Standard Deviation)
 61  (11)   62  (10)   62  (11)   62  (10) 
Gender 
[Units: Participants]
       
Female   13   14   14   41 
Male   12   10   12   34 
Ethnicity (NIH/OMB) 
[Units: Participants]
       
Hispanic or Latino   0   2   0   2 
Not Hispanic or Latino   25   22   26   73 
Unknown or Not Reported   0   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
       
American Indian or Alaska Native   0   0   0   0 
Asian   0   0   0   0 
Native Hawaiian or Other Pacific Islander   0   0   1   1 
Black or African American   0   0   0   0 
White   24   22   24   70 
More than one race   0   0   0   0 
Unknown or Not Reported   1   2   1   4 
Region of Enrollment 
[Units: Participants]
       
United States   25   24   26   75 
Years since symptom onset 
[Units: Years]
Mean (Standard Deviation)
 2.4  (1.3)   2.8  (1.9)   2.2  (2.0)   2.4  (1.8) 
Years since diagnosis 
[Units: Years]
Mean (Standard Deviation)
 1.1  (1.3)   1.3  (1.0)   0.6  (0.7)   1.0  (1.1) 
Serum Urate 
[Units: mg/dL]
Mean (Standard Deviation)
 4.5  (0.7)   4.3  (1.2)   4.6  (0.9)   4.5  (0.9) 
Serum urate in women 
[Units: mg/dL]
Mean (Standard Deviation)
 4.4  (0.8)   3.9  (1.3)   4.4  (0.8)   4.2  (1.0) 
Serum urate in men 
[Units: mg/dL]
Mean (Standard Deviation)
 4.7  (0.5)   5.0  (0.8)   4.9  (0.9)   4.8  (0.7) 
United Parkinson's Disease Rating Scale (UPDRS) score total [1] 
[Units: Points]
Mean (Standard Deviation)
 23  (10)   20  (9)   21  (10)   22  (10) 
[1] The UPDRS is designed to monitor disability and impairment due to Parkinson's disease. It comprises several parts. Part I evaluates "Mentation, Behavior, and Mood" (with a maximum of 16 points; more points are worse); Part II evaluates "Activities of Daily Living" (with a maximum of 52 points); Part III entails a "Motor Examination" (with a maximum of 108 points). Total score of Parts I-III sums the points from all parts and thus can range from a minimum of 0 (best) to a maximum of 176 (worst).
Montreal Cognitive Assessment (MoCA) [1] 
[Units: Score]
Mean (Standard Deviation)
 28  (1.9)   28  (1.8)   28  (2.0)   28  (1.9) 
[1] The MoCA assesses short term and working memory, visual-spatial abilities, executive function, attention, concentration, language and orientation. The total score ranges from 0 to 30 (highest function).
Geriatric Depression Scale-short form (GDS-S) [1] 
[Units: Score]
Mean (Standard Deviation)
 1.5  (1.9)   1.4  (1.7)   1.8  (2.6)   1.5  (2.1) 
[1] GDS-S is a short 15 'yes/no' question instrument for assessing depression in older adults. Questions are answered by the research participant (i.e., self-rater). Scores range range from 0 to 15 and higher scores represent greater depression. Scores of 5-9 and >9 have been correlated with mild and moderate-severe depression, respectively.


  Outcome Measures
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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) ]
  Hide Outcome Measure 30

Measure Type Secondary
Measure Title Change in Serum Urate
Measure Description Change from an Average of Baseline and Screening Visits
Time Frame Visit 05 from Baseline (i.e., between -45 days and +12 weeks)  
Safety Issue No  

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.
No text entered.

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

Measured Values
   [A:]Placebo   [B:]Mild   [C.]Moderate 
Participants Analyzed 
[Units: Participants]
 24   24   26 
Change in Serum Urate 
[Units: mg/dL]
Mean (Standard Deviation)
 0.1  (0.42)   1.51  (0.8)   2.42  (1.08) 

No statistical analysis provided for Change in Serum Urate



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
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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: 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
Study First Received: January 27, 2009
Results First Received: December 26, 2013
Last Updated: May 30, 2014
Health Authority: United States: Food and Drug Administration