Trial Outcomes & Findings for Safety of Urate Elevation in Parkinson's Disease (NCT NCT00833690)
NCT ID: NCT00833690
Last Updated: 2014-06-05
Results Overview
Defined as the extent to which assigned treatment could continue without prolonged dose reduction (\>48 consecutive days or \>73 cumulative days, which is 10% of total 2-year follow-up) due to adverse experiences (AEs), and was assessed after 6 and 24 months on study drug. Units of measure are percentage points (i.e., % of participants in the group).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
75 participants
Primary outcome timeframe
6 months
Results posted on
2014-06-05
Participant Flow
Participant milestones
| Measure |
[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
|
|---|---|---|---|
|
Overall Study
STARTED
|
25
|
24
|
26
|
|
Overall Study
COMPLETED
|
21
|
22
|
26
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
0
|
Reasons for withdrawal
| Measure |
[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
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
|
Overall Study
Discontinued study drug
|
3
|
2
|
0
|
Baseline Characteristics
Safety of Urate Elevation in Parkinson's Disease
Baseline characteristics by cohort
| Measure |
[A:]Placebo
n=25 Participants
Placebo to produce no urate elevation
|
[B:]Mild
n=24 Participants
Inosine to produce a mild urate elevation
|
[C.]Moderate
n=26 Participants
Inosine to produce a moderate urate elevation
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 11 • n=99 Participants
|
62 years
STANDARD_DEVIATION 10 • n=107 Participants
|
62 years
STANDARD_DEVIATION 11 • n=206 Participants
|
62 years
STANDARD_DEVIATION 10 • n=7 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
41 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
34 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
73 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
70 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=99 Participants
|
24 participants
n=107 Participants
|
26 participants
n=206 Participants
|
75 participants
n=7 Participants
|
|
Years since symptom onset
|
2.4 Years
STANDARD_DEVIATION 1.3 • n=99 Participants
|
2.8 Years
STANDARD_DEVIATION 1.9 • n=107 Participants
|
2.2 Years
STANDARD_DEVIATION 2.0 • n=206 Participants
|
2.4 Years
STANDARD_DEVIATION 1.8 • n=7 Participants
|
|
Years since diagnosis
|
1.1 Years
STANDARD_DEVIATION 1.3 • n=99 Participants
|
1.3 Years
STANDARD_DEVIATION 1.0 • n=107 Participants
|
0.6 Years
STANDARD_DEVIATION 0.7 • n=206 Participants
|
1.0 Years
STANDARD_DEVIATION 1.1 • n=7 Participants
|
|
Serum Urate
|
4.5 mg/dL
STANDARD_DEVIATION 0.7 • n=99 Participants
|
4.3 mg/dL
STANDARD_DEVIATION 1.2 • n=107 Participants
|
4.6 mg/dL
STANDARD_DEVIATION 0.9 • n=206 Participants
|
4.5 mg/dL
STANDARD_DEVIATION 0.9 • n=7 Participants
|
|
Serum urate in women
|
4.4 mg/dL
STANDARD_DEVIATION 0.8 • n=99 Participants
|
3.9 mg/dL
STANDARD_DEVIATION 1.3 • n=107 Participants
|
4.4 mg/dL
STANDARD_DEVIATION 0.8 • n=206 Participants
|
4.2 mg/dL
STANDARD_DEVIATION 1.0 • n=7 Participants
|
|
Serum urate in men
|
4.7 mg/dL
STANDARD_DEVIATION 0.5 • n=99 Participants
|
5.0 mg/dL
STANDARD_DEVIATION 0.8 • n=107 Participants
|
4.9 mg/dL
STANDARD_DEVIATION 0.9 • n=206 Participants
|
4.8 mg/dL
STANDARD_DEVIATION 0.7 • n=7 Participants
|
|
United Parkinson's Disease Rating Scale (UPDRS) score total
|
23 points
STANDARD_DEVIATION 10 • n=99 Participants
|
20 points
STANDARD_DEVIATION 9 • n=107 Participants
|
21 points
STANDARD_DEVIATION 10 • n=206 Participants
|
22 points
STANDARD_DEVIATION 10 • n=7 Participants
|
|
Montreal Cognitive Assessment (MoCA)
|
28 Score
STANDARD_DEVIATION 1.9 • n=99 Participants
|
28 Score
STANDARD_DEVIATION 1.8 • n=107 Participants
|
28 Score
STANDARD_DEVIATION 2.0 • n=206 Participants
|
28 Score
STANDARD_DEVIATION 1.9 • n=7 Participants
|
|
Geriatric Depression Scale-short form (GDS-S)
|
1.5 Score
STANDARD_DEVIATION 1.9 • n=99 Participants
|
1.4 Score
STANDARD_DEVIATION 1.7 • n=107 Participants
|
1.8 Score
STANDARD_DEVIATION 2.6 • n=206 Participants
|
1.5 Score
STANDARD_DEVIATION 2.1 • n=7 Participants
|
PRIMARY outcome
Timeframe: 6 monthsDefined as the extent to which assigned treatment could continue without prolonged dose reduction (\>48 consecutive days or \>73 cumulative days, which is 10% of total 2-year follow-up) due to adverse experiences (AEs), and was assessed after 6 and 24 months on study drug. Units of measure are percentage points (i.e., % of participants in the group).
Outcome measures
| Measure |
[A:]Placebo
n=25 Participants
Placebo to produce no urate elevation
|
[B:]Mild
n=24 Participants
Inosine to produce a mild urate elevation
|
[C.]Moderate
n=26 Participants
Inosine to produce a moderate urate elevation
|
|---|---|---|---|
|
Tolerability
|
96 percentage of participants
|
96 percentage of participants
|
100 percentage of participants
|
PRIMARY outcome
Timeframe: 24 monthsDefined as the extent to which assigned treatment could continue without prolonged dose reduction (\>48 consecutive days or \>73 cumulative days, which is 10% of total 2-year follow-up) due to AEs, and was assessed after 6 and 24 months on study drug. Units of measure are percentage points (i.e., % of participants in the group).
Outcome measures
| Measure |
[A:]Placebo
n=25 Participants
Placebo to produce no urate elevation
|
[B:]Mild
n=24 Participants
Inosine to produce a mild urate elevation
|
[C.]Moderate
n=26 Participants
Inosine to produce a moderate urate elevation
|
|---|---|---|---|
|
Tolerability
|
86 percentage of participants
|
92 percentage of participants
|
96 percentage of participants
|
PRIMARY outcome
Timeframe: 24 monthsDefined as absence of serious adverse experiences (SAEs) that warranted terminating an inosine treatment arm or the trial, as determined by the Data and Safety Monitoring Committee.
Outcome measures
| Measure |
[A:]Placebo
n=25 Participants
Placebo to produce no urate elevation
|
[B:]Mild
n=24 Participants
Inosine to produce a mild urate elevation
|
[C.]Moderate
n=26 Participants
Inosine to produce a moderate urate elevation
|
|---|---|---|---|
|
Safety
|
11 Events
|
2 Events
|
4 Events
|
SECONDARY outcome
Timeframe: 12 weeksUrate concentration in cerebrospinal fluid (CSF)
Outcome measures
| Measure |
[A:]Placebo
n=11 Participants
Placebo to produce no urate elevation
|
[B:]Mild
n=15 Participants
Inosine to produce a mild urate elevation
|
[C.]Moderate
n=18 Participants
Inosine to produce a moderate urate elevation
|
|---|---|---|---|
|
CSF Urate (All Patients)
|
427 mcg/dL
Standard Deviation 190
|
544 mcg/dL
Standard Deviation 148
|
594 mcg/dL
Standard Deviation 175
|
SECONDARY outcome
Timeframe: 12 weeksOutcome measures
| Measure |
[A:]Placebo
n=5 Participants
Placebo to produce no urate elevation
|
[B:]Mild
n=9 Participants
Inosine to produce a mild urate elevation
|
[C.]Moderate
n=10 Participants
Inosine to produce a moderate urate elevation
|
|---|---|---|---|
|
CSF Urate (Females)
|
285 mcg/dL
Standard Deviation 69
|
517 mcg/dL
Standard Deviation 169
|
575 mcg/dL
Standard Deviation 176
|
SECONDARY outcome
Timeframe: 12 weeksOutcome measures
| Measure |
[A:]Placebo
n=6 Participants
Placebo to produce no urate elevation
|
[B:]Mild
n=6 Participants
Inosine to produce a mild urate elevation
|
[C.]Moderate
n=8 Participants
Inosine to produce a moderate urate elevation
|
|---|---|---|---|
|
CSF Urate (Males)
|
546 mcg/dL
Standard Deviation 178
|
586 mcg/dL
Standard Deviation 113
|
619 mcg/dL
Standard Deviation 184
|
SECONDARY outcome
Timeframe: 12 weeksAlthough CSF urate was not measured at baseline, the change of CSF urate from baseline may be indirectly estimated by the ratio of CSF urate (at the 12 week visit when a lumbar puncture was performed) to the serum urate measured in the same subject at baseline. Baseline serum urate and CSF urate concentrations are directly correlated with one another (i.e., individuals with higher serum urate concentrations tend to have higher CSF urate concentrations) even though the concentration of urate in CSF is typically \~10% of that in serum. The ratio of CSF urate to baseline serum urate can be expressed as the percentage of the value of urate concentration measured in serum at baseline that is measured in CSF (at week 12).
Outcome measures
| Measure |
[A:]Placebo
n=11 Participants
Placebo to produce no urate elevation
|
[B:]Mild
n=15 Participants
Inosine to produce a mild urate elevation
|
[C.]Moderate
n=18 Participants
Inosine to produce a moderate urate elevation
|
|---|---|---|---|
|
CSF Urate as a Proportion of Baseline Serum Urate (All Patients)
|
9.6 percentage of baseline serum urate
Standard Deviation 4.0
|
13.1 percentage of baseline serum urate
Standard Deviation 4.0
|
13.4 percentage of baseline serum urate
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: 12 weeksAlthough CSF urate was not measured at baseline, the change of CSF urate from baseline may be indirectly estimated by the ratio of CSF urate (at the 12 week visit when a lumbar puncture was performed) to the serum urate measured in the same subject at baseline. Baseline serum urate and CSF urate concentrations are directly correlated with one another (i.e., individuals with higher serum urate concentrations tend to have higher CSF urate concentrations) even though the concentration of urate in CSF is typically \~10% of that in serum. The ratio of CSF urate to baseline serum urate can be expressed as the percentage of the value of urate concentration measured in serum at baseline that is measured in CSF (at week 12).
Outcome measures
| Measure |
[A:]Placebo
n=5 Participants
Placebo to produce no urate elevation
|
[B:]Mild
n=9 Participants
Inosine to produce a mild urate elevation
|
[C.]Moderate
n=10 Participants
Inosine to produce a moderate urate elevation
|
|---|---|---|---|
|
CSF Urate as a Proportion of Baseline Serum Urate (Females)
|
6.7 percentage of baseline serum urate
Standard Deviation 1.8
|
13.5 percentage of baseline serum urate
Standard Deviation 5.0
|
13.3 percentage of baseline serum urate
Standard Deviation 5.0
|
SECONDARY outcome
Timeframe: 12 weeksAlthough CSF urate was not measured at baseline, the change of CSF urate from baseline may be indirectly estimated by the ratio of CSF urate (at the 12 week visit when a lumbar puncture was performed) to the serum urate measured in the same subject at baseline. Baseline serum urate and CSF urate concentrations are directly correlated with one another (i.e., individuals with higher serum urate concentrations tend to have higher CSF urate concentrations) even though the concentration of urate in CSF is typically \~10% of that in serum. The ratio of CSF urate to baseline serum urate can be expressed as the percentage of the value of urate concentration measured in serum at baseline that is measured in CSF (at week 12).
Outcome measures
| Measure |
[A:]Placebo
n=6 Participants
Placebo to produce no urate elevation
|
[B:]Mild
n=6 Participants
Inosine to produce a mild urate elevation
|
[C.]Moderate
n=8 Participants
Inosine to produce a moderate urate elevation
|
|---|---|---|---|
|
CSF Urate as a Proportion of Baseline Serum Urate (Males)
|
12.0 percentage of baseline serum urate
Standard Deviation 3.8
|
12.4 percentage of baseline serum urate
Standard Deviation 2.2
|
13.4 percentage of baseline serum urate
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: 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.From blood sample drawn prior to enrollment
Outcome measures
| Measure |
[A:]Placebo
n=25 Participants
Placebo to produce no urate elevation
|
[B:]Mild
n=24 Participants
Inosine to produce a mild urate elevation
|
[C.]Moderate
n=26 Participants
Inosine to produce a moderate urate elevation
|
|---|---|---|---|
|
Serum Urate
Screening Visit 1
|
4.63 mg/dL
Standard Deviation 0.62
|
4.28 mg/dL
Standard Deviation 0.86
|
4.39 mg/dL
Standard Deviation 0.78
|
|
Serum Urate
Screening Visit 2
|
4.78 mg/dL
Standard Deviation 0.6
|
4.4 mg/dL
Standard Deviation 0.88
|
4.48 mg/dL
Standard Deviation 0.75
|
SECONDARY outcome
Timeframe: Baseline VisitFrom blood sample drawn prior to enrollment
Outcome measures
| Measure |
[A:]Placebo
n=25 Participants
Placebo to produce no urate elevation
|
[B:]Mild
n=23 Participants
Inosine to produce a mild urate elevation
|
[C.]Moderate
n=26 Participants
Inosine to produce a moderate urate elevation
|
|---|---|---|---|
|
Serum Urate
|
4.54 mg/dL
Standard Deviation 0.69
|
4.32 mg/dL
Standard Deviation 1.2
|
4.62 mg/dL
Standard Deviation 0.86
|
SECONDARY outcome
Timeframe: Visit 01 (Week 2; 14 +/- 3 days after Baseline Visit)From blood sample drawn after taking study drug that day
Outcome measures
| Measure |
[A:]Placebo
n=25 Participants
Placebo to produce no urate elevation
|
[B:]Mild
n=24 Participants
Inosine to produce a mild urate elevation
|
[C.]Moderate
n=26 Participants
Inosine to produce a moderate urate elevation
|
|---|---|---|---|
|
Serum Urate
|
4.8 mg/dL
Standard Deviation 0.65
|
6.44 mg/dL
Standard Deviation 1.29
|
6.93 mg/dL
Standard Deviation 1.42
|
SECONDARY outcome
Timeframe: Visit 02 (Week 4; 28 +/- 3 days after Baseline Visit)From blood sample drawn after taking study drug that day
Outcome measures
| Measure |
[A:]Placebo
n=24 Participants
Placebo to produce no urate elevation
|
[B:]Mild
n=24 Participants
Inosine to produce a mild urate elevation
|
[C.]Moderate
n=26 Participants
Inosine to produce a moderate urate elevation
|
|---|---|---|---|
|
Serum Urate
|
4.73 mg/dL
Standard Deviation 0.65
|
6.58 mg/dL
Standard Deviation 0.87
|
7.9 mg/dL
Standard Deviation 1.29
|
SECONDARY outcome
Timeframe: Visit 03 (Week 6; 42 +/- 3 days after Baseline Visit)From blood sample drawn after taking study drug that day
Outcome measures
| Measure |
[A:]Placebo
n=24 Participants
Placebo to produce no urate elevation
|
[B:]Mild
n=24 Participants
Inosine to produce a mild urate elevation
|
[C.]Moderate
n=26 Participants
Inosine to produce a moderate urate elevation
|
|---|---|---|---|
|
Serum Urate
|
4.85 mg/dL
Standard Deviation 0.77
|
6.69 mg/dL
Standard Deviation 0.78
|
7.51 mg/dL
Standard Deviation 1.24
|
SECONDARY outcome
Timeframe: Visit 04 (Week 9; 63 +/- 5 days after Baseline Visit)From blood sample drawn after taking study drug that day
Outcome measures
| Measure |
[A:]Placebo
n=24 Participants
Placebo to produce no urate elevation
|
[B:]Mild
n=24 Participants
Inosine to produce a mild urate elevation
|
[C.]Moderate
n=26 Participants
Inosine to produce a moderate urate elevation
|
|---|---|---|---|
|
Serum Urate
|
4.62 mg/dL
Standard Deviation 0.58
|
6.81 mg/dL
Standard Deviation 1.22
|
7.62 mg/dL
Standard Deviation 1.02
|
SECONDARY outcome
Timeframe: Visit 05 (Week 12; 84 +/- 7 days after Baseline Visit)From blood sample drawn before taking study drug that day
Outcome measures
| Measure |
[A:]Placebo
n=24 Participants
Placebo to produce no urate elevation
|
[B:]Mild
n=24 Participants
Inosine to produce a mild urate elevation
|
[C.]Moderate
n=26 Participants
Inosine to produce a moderate urate elevation
|
|---|---|---|---|
|
Serum Urate
|
4.74 mg/dL
Standard Deviation 0.59
|
5.85 mg/dL
Standard Deviation 1.02
|
6.91 mg/dL
Standard Deviation 1.09
|
SECONDARY outcome
Timeframe: Visit 06 (Month 6; 180 +/- 7 days after Baseline Visit)From blood sample drawn after taking study drug that day
Outcome measures
| Measure |
[A:]Placebo
n=24 Participants
Placebo to produce no urate elevation
|
[B:]Mild
n=23 Participants
Inosine to produce a mild urate elevation
|
[C.]Moderate
n=26 Participants
Inosine to produce a moderate urate elevation
|
|---|---|---|---|
|
Serum Urate
|
4.85 mg/dL
Standard Deviation 1
|
6.94 mg/dL
Standard Deviation 1.6
|
8.27 mg/dL
Standard Deviation 0.74
|
SECONDARY outcome
Timeframe: Visit 07 (Month 9; 270 +/- 7 days after Baseline Visit)From blood sample drawn after taking study drug that day
Outcome measures
| Measure |
[A:]Placebo
n=24 Participants
Placebo to produce no urate elevation
|
[B:]Mild
n=24 Participants
Inosine to produce a mild urate elevation
|
[C.]Moderate
n=26 Participants
Inosine to produce a moderate urate elevation
|
|---|---|---|---|
|
Serum Urate
|
4.77 mg/dL
Standard Deviation 0.89
|
6.77 mg/dL
Standard Deviation 1.51
|
8.06 mg/dL
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Visit 08 (Month 12; 360 +/- 7 days after Baseline Visit)From blood sample drawn after taking study drug that day
Outcome measures
| Measure |
[A:]Placebo
n=22 Participants
Placebo to produce no urate elevation
|
[B:]Mild
n=23 Participants
Inosine to produce a mild urate elevation
|
[C.]Moderate
n=24 Participants
Inosine to produce a moderate urate elevation
|
|---|---|---|---|
|
Serum Urate
|
4.79 mg/dL
Standard Deviation 0.89
|
6.87 mg/dL
Standard Deviation 1.05
|
7.41 mg/dL
Standard Deviation 0.96
|
SECONDARY outcome
Timeframe: Visit 09 (Month 15; 450 +/- 7 days after Baseline Visit)From blood sample drawn after taking study drug that day
Outcome measures
| Measure |
[A:]Placebo
n=18 Participants
Placebo to produce no urate elevation
|
[B:]Mild
n=19 Participants
Inosine to produce a mild urate elevation
|
[C.]Moderate
n=22 Participants
Inosine to produce a moderate urate elevation
|
|---|---|---|---|
|
Serum Urate
|
4.62 mg/dL
Standard Deviation 0.69
|
7.26 mg/dL
Standard Deviation 0.96
|
7.64 mg/dL
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Visit 10 (Month 18; 540 +/- 7 days after Baseline Visit)From blood sample drawn after taking study drug that day
Outcome measures
| Measure |
[A:]Placebo
n=16 Participants
Placebo to produce no urate elevation
|
[B:]Mild
n=16 Participants
Inosine to produce a mild urate elevation
|
[C.]Moderate
n=17 Participants
Inosine to produce a moderate urate elevation
|
|---|---|---|---|
|
Serum Urate
|
4.58 mg/dL
Standard Deviation 0.76
|
7 mg/dL
Standard Deviation 0.97
|
7.64 mg/dL
Standard Deviation 0.98
|
SECONDARY outcome
Timeframe: Visit 11 (Month 21; 630 +/- 7 days after Baseline Visit)From blood sample drawn after taking study drug that day
Outcome measures
| Measure |
[A:]Placebo
n=7 Participants
Placebo to produce no urate elevation
|
[B:]Mild
n=11 Participants
Inosine to produce a mild urate elevation
|
[C.]Moderate
n=14 Participants
Inosine to produce a moderate urate elevation
|
|---|---|---|---|
|
Serum Urate
|
4.6 mg/dL
Standard Deviation 0.47
|
7.12 mg/dL
Standard Deviation 1.21
|
7.56 mg/dL
Standard Deviation 1.08
|
SECONDARY outcome
Timeframe: Visit 12 (Month 24; 720 +/- 7 days after Baseline Visit)From blood sample drawn after taking study drug that day
Outcome measures
| Measure |
[A:]Placebo
n=5 Participants
Placebo to produce no urate elevation
|
[B:]Mild
n=10 Participants
Inosine to produce a mild urate elevation
|
[C.]Moderate
n=9 Participants
Inosine to produce a moderate urate elevation
|
|---|---|---|---|
|
Serum Urate
|
4.41 mg/dL
Standard Deviation 0.99
|
6.84 mg/dL
Standard Deviation 0.76
|
7.19 mg/dL
Standard Deviation 1.19
|
SECONDARY outcome
Timeframe: End of Study Drug Visit (ESD) (Month 9-24; 263-727 days after Baseline Visit)From blood sample drawn after taking study drug that day
Outcome measures
| Measure |
[A:]Placebo
n=24 Participants
Placebo to produce no urate elevation
|
[B:]Mild
n=24 Participants
Inosine to produce a mild urate elevation
|
[C.]Moderate
n=26 Participants
Inosine to produce a moderate urate elevation
|
|---|---|---|---|
|
Serum Urate
|
4.66 mg/dL
Standard Deviation 0.79
|
6.48 mg/dL
Standard Deviation 1.25
|
7.55 mg/dL
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: Safety Visit (SV); 30 +/- 3 days following ESD or Month 24 VisitFrom blood sample drawn a month after stopping study drug
Outcome measures
| Measure |
[A:]Placebo
n=24 Participants
Placebo to produce no urate elevation
|
[B:]Mild
n=23 Participants
Inosine to produce a mild urate elevation
|
[C.]Moderate
n=26 Participants
Inosine to produce a moderate urate elevation
|
|---|---|---|---|
|
Serum Urate
|
4.74 mg/dL
Standard Deviation 0.77
|
4.69 mg/dL
Standard Deviation 1.28
|
4.38 mg/dL
Standard Deviation 0.78
|
SECONDARY outcome
Timeframe: Visit 01 from Baseline (i.e., between -45 days and +2 weeks)Change from an Average of Baseline and Screening Visits
Outcome measures
| Measure |
[A:]Placebo
n=25 Participants
Placebo to produce no urate elevation
|
[B:]Mild
n=24 Participants
Inosine to produce a mild urate elevation
|
[C.]Moderate
n=26 Participants
Inosine to produce a moderate urate elevation
|
|---|---|---|---|
|
Change in Serum Urate
|
0.15 mg/dL
Standard Deviation 0.41
|
2.1 mg/dL
Standard Deviation 0.83
|
2.44 mg/dL
Standard Deviation 1.07
|
SECONDARY outcome
Timeframe: Visit 02 from Baseline (i.e., between -45 days and +4 weeks)Change from an Average of Baseline and Screening Visits
Outcome measures
| Measure |
[A:]Placebo
n=24 Participants
Placebo to produce no urate elevation
|
[B:]Mild
n=24 Participants
Inosine to produce a mild urate elevation
|
[C.]Moderate
n=26 Participants
Inosine to produce a moderate urate elevation
|
|---|---|---|---|
|
Change in Serum Urate
|
0.09 mg/dL
Standard Deviation 0.48
|
2.24 mg/dL
Standard Deviation 1.13
|
3.41 mg/dL
Standard Deviation 1.22
|
SECONDARY outcome
Timeframe: Visit 03 from Baseline (i.e., between -45 days and +6 weeks)Change from an Average of Baseline and Screening Visits
Outcome measures
| Measure |
[A:]Placebo
n=24 Participants
Placebo to produce no urate elevation
|
[B:]Mild
n=24 Participants
Inosine to produce a mild urate elevation
|
[C.]Moderate
n=26 Participants
Inosine to produce a moderate urate elevation
|
|---|---|---|---|
|
Change in Serum Urate
|
0.22 mg/dL
Standard Deviation 0.51
|
2.35 mg/dL
Standard Deviation 1.03
|
3.02 mg/dL
Standard Deviation 1.13
|
SECONDARY outcome
Timeframe: Visit 04 from Baseline (i.e., between -45 days and +9 weeks)Change from an Average of Baseline and Screening Visits
Outcome measures
| Measure |
[A:]Placebo
n=24 Participants
Placebo to produce no urate elevation
|
[B:]Mild
n=24 Participants
Inosine to produce a mild urate elevation
|
[C.]Moderate
n=26 Participants
Inosine to produce a moderate urate elevation
|
|---|---|---|---|
|
Change in Serum Urate
|
-0.02 mg/dL
Standard Deviation 0.35
|
2.47 mg/dL
Standard Deviation 1.34
|
3.13 mg/dL
Standard Deviation 1.16
|
SECONDARY outcome
Timeframe: Visit 05 from Baseline (i.e., between -45 days and +12 weeks)Change from an Average of Baseline and Screening Visits
Outcome measures
| Measure |
[A:]Placebo
n=24 Participants
Placebo to produce no urate elevation
|
[B:]Mild
n=24 Participants
Inosine to produce a mild urate elevation
|
[C.]Moderate
n=26 Participants
Inosine to produce a moderate urate elevation
|
|---|---|---|---|
|
Change in Serum Urate
|
0.1 mg/dL
Standard Deviation 0.42
|
1.51 mg/dL
Standard Deviation 0.8
|
2.42 mg/dL
Standard Deviation 1.08
|
SECONDARY outcome
Timeframe: Visit 06 from Baseline (i.e., between -45 days and +6 months)Change from an Average of Baseline and Screening Visits
Outcome measures
| Measure |
[A:]Placebo
n=24 Participants
Placebo to produce no urate elevation
|
[B:]Mild
n=23 Participants
Inosine to produce a mild urate elevation
|
[C.]Moderate
n=26 Participants
Inosine to produce a moderate urate elevation
|
|---|---|---|---|
|
Change in Serum Urate
|
0.21 mg/dL
Standard Deviation 0.86
|
2.55 mg/dL
Standard Deviation 1.4
|
3.78 mg/dL
Standard Deviation 0.95
|
SECONDARY outcome
Timeframe: Visit 07 from Baseline (i.e., between -45 days and +9 months)Change from an Average of Baseline and Screening Visits
Outcome measures
| Measure |
[A:]Placebo
n=24 Participants
Placebo to produce no urate elevation
|
[B:]Mild
n=24 Participants
Inosine to produce a mild urate elevation
|
[C.]Moderate
n=26 Participants
Inosine to produce a moderate urate elevation
|
|---|---|---|---|
|
Change in Serum Urate
|
0.14 mg/dL
Standard Deviation 0.68
|
2.43 mg/dL
Standard Deviation 1.56
|
3.56 mg/dL
Standard Deviation 1.51
|
SECONDARY outcome
Timeframe: Visit 08 from Baseline (i.e., between -45 days and +12 months)Change from an Average of Baseline and Screening Visits
Outcome measures
| Measure |
[A:]Placebo
n=22 Participants
Placebo to produce no urate elevation
|
[B:]Mild
n=23 Participants
Inosine to produce a mild urate elevation
|
[C.]Moderate
n=24 Participants
Inosine to produce a moderate urate elevation
|
|---|---|---|---|
|
Change in Serum Urate
|
0.2 mg/dL
Standard Deviation 0.78
|
2.46 mg/dL
Standard Deviation 1.24
|
2.96 mg/dL
Standard Deviation 1.28
|
SECONDARY outcome
Timeframe: Visit 09 from Baseline (i.e., between -45 days and +15 months)Change from an Average of Baseline and Screening Visits
Outcome measures
| Measure |
[A:]Placebo
n=18 Participants
Placebo to produce no urate elevation
|
[B:]Mild
n=19 Participants
Inosine to produce a mild urate elevation
|
[C.]Moderate
n=22 Participants
Inosine to produce a moderate urate elevation
|
|---|---|---|---|
|
Change in Serum Urate
|
0 mg/dL
Standard Deviation 0.67
|
2.9 mg/dL
Standard Deviation 0.98
|
3.19 mg/dL
Standard Deviation 1.18
|
SECONDARY outcome
Timeframe: Visit 10 from Baseline (i.e., between -45 days and +18 months)Change from an Average of Baseline and Screening Visits
Outcome measures
| Measure |
[A:]Placebo
n=16 Participants
Placebo to produce no urate elevation
|
[B:]Mild
n=16 Participants
Inosine to produce a mild urate elevation
|
[C.]Moderate
n=17 Participants
Inosine to produce a moderate urate elevation
|
|---|---|---|---|
|
Change in Serum Urate
|
-0.07 mg/dL
Standard Deviation 0.43
|
2.49 mg/dL
Standard Deviation 1.07
|
3.26 mg/dL
Standard Deviation 1.25
|
SECONDARY outcome
Timeframe: Visit 11 from Baseline (i.e., between -45 days and +21 months)Change from an Average of Baseline and Screening Visits
Outcome measures
| Measure |
[A:]Placebo
n=7 Participants
Placebo to produce no urate elevation
|
[B:]Mild
n=11 Participants
Inosine to produce a mild urate elevation
|
[C.]Moderate
n=14 Participants
Inosine to produce a moderate urate elevation
|
|---|---|---|---|
|
Change in Serum Urate
|
-0.07 mg/dL
Standard Deviation 0.59
|
2.53 mg/dL
Standard Deviation 1.12
|
3.11 mg/dL
Standard Deviation 1.46
|
SECONDARY outcome
Timeframe: Visit 12 from Baseline (i.e., between -45 days and +24 months)Change from an Average of Baseline and Screening Visits
Outcome measures
| Measure |
[A:]Placebo
n=5 Participants
Placebo to produce no urate elevation
|
[B:]Mild
n=10 Participants
Inosine to produce a mild urate elevation
|
[C.]Moderate
n=9 Participants
Inosine to produce a moderate urate elevation
|
|---|---|---|---|
|
Change in Serum Urate
|
-0.29 mg/dL
Standard Deviation 1.08
|
2.22 mg/dL
Standard Deviation 0.96
|
2.93 mg/dL
Standard Deviation 1.38
|
SECONDARY outcome
Timeframe: Safety Visit (SV) from Baseline (i.e., between -45 days and +760 days [+1 month after ESD Visit])Change from an Average of Baseline and Screening Visits
Outcome measures
| Measure |
[A:]Placebo
n=24 Participants
Placebo to produce no urate elevation
|
[B:]Mild
n=23 Participants
Inosine to produce a mild urate elevation
|
[C.]Moderate
n=26 Participants
Inosine to produce a moderate urate elevation
|
|---|---|---|---|
|
Change in Serum Urate
|
0.1 mg/dL
Standard Deviation 0.62
|
0.35 mg/dL
Standard Deviation 0.88
|
-0.11 mg/dL
Standard Deviation 0.61
|
SECONDARY outcome
Timeframe: Safety Visit (SV) from End of Study Drug Visit (ESD); i.e., between +263 and +760 days)Change from Last Visit on Study Drug
Outcome measures
| Measure |
[A:]Placebo
n=23 Participants
Placebo to produce no urate elevation
|
[B:]Mild
n=23 Participants
Inosine to produce a mild urate elevation
|
[C.]Moderate
n=26 Participants
Inosine to produce a moderate urate elevation
|
|---|---|---|---|
|
Change in Serum Urate
|
0.12 mg/dL
Standard Deviation 0.51
|
-1.8 mg/dL
Standard Deviation 1.33
|
-3.2 mg/dL
Standard Deviation 1.63
|
Adverse Events
[A:]Placebo
Serious events: 9 serious events
Other events: 18 other events
Deaths: 0 deaths
[B:]Mild
Serious events: 2 serious events
Other events: 22 other events
Deaths: 0 deaths
[C.]Moderate
Serious events: 4 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
[A:]Placebo
n=25 participants at risk
Placebo to produce no urate elevation
|
[B:]Mild
n=24 participants at risk
Inosine to produce a mild urate elevation
|
[C.]Moderate
n=26 participants at risk
Inosine to produce a moderate urate elevation
|
|---|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
4.0%
1/25 • Number of events 1
|
0.00%
0/24
|
0.00%
0/26
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
12.0%
3/25 • Number of events 3
|
0.00%
0/24
|
0.00%
0/26
|
|
Nervous system disorders
Cerebrovascular accident
|
4.0%
1/25 • Number of events 1
|
0.00%
0/24
|
0.00%
0/26
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/25
|
4.2%
1/24 • Number of events 1
|
0.00%
0/26
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/25
|
0.00%
0/24
|
3.8%
1/26 • Number of events 1
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/25
|
0.00%
0/24
|
3.8%
1/26 • Number of events 1
|
|
Psychiatric disorders
Depression
|
4.0%
1/25 • Number of events 1
|
0.00%
0/24
|
0.00%
0/26
|
|
Infections and infestations
Human ehrlichiosis
|
0.00%
0/25
|
4.2%
1/24 • Number of events 1
|
0.00%
0/26
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/25
|
0.00%
0/24
|
3.8%
1/26 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
4.0%
1/25 • Number of events 1
|
0.00%
0/24
|
0.00%
0/26
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
4.0%
1/25 • Number of events 1
|
0.00%
0/24
|
0.00%
0/26
|
|
Nervous system disorders
Radiculopathy
|
4.0%
1/25 • Number of events 1
|
0.00%
0/24
|
0.00%
0/26
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/25
|
0.00%
0/24
|
3.8%
1/26 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
4.0%
1/25 • Number of events 1
|
0.00%
0/24
|
0.00%
0/26
|
|
Infections and infestations
Urosepsis
|
4.0%
1/25 • Number of events 1
|
0.00%
0/24
|
0.00%
0/26
|
Other adverse events
| Measure |
[A:]Placebo
n=25 participants at risk
Placebo to produce no urate elevation
|
[B:]Mild
n=24 participants at risk
Inosine to produce a mild urate elevation
|
[C.]Moderate
n=26 participants at risk
Inosine to produce a moderate urate elevation
|
|---|---|---|---|
|
Psychiatric disorders
Anxiety
|
4.0%
1/25 • Number of events 1
|
0.00%
0/24
|
7.7%
2/26 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.0%
2/25 • Number of events 3
|
12.5%
3/24 • Number of events 4
|
15.4%
4/26 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
16.0%
4/25 • Number of events 4
|
0.00%
0/24
|
0.00%
0/26
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.0%
3/25 • Number of events 4
|
8.3%
2/24 • Number of events 2
|
15.4%
4/26 • Number of events 6
|
|
Gastrointestinal disorders
Constipation
|
12.0%
3/25 • Number of events 3
|
0.00%
0/24
|
0.00%
0/26
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.0%
2/25 • Number of events 3
|
0.00%
0/24
|
3.8%
1/26 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
8.0%
2/25 • Number of events 2
|
0.00%
0/24
|
0.00%
0/26
|
|
Psychiatric disorders
Depression
|
16.0%
4/25 • Number of events 4
|
4.2%
1/24 • Number of events 1
|
11.5%
3/26 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/25
|
0.00%
0/24
|
7.7%
2/26 • Number of events 2
|
|
Gastrointestinal disorders
Dry Mouth
|
4.0%
1/25 • Number of events 1
|
0.00%
0/24
|
11.5%
3/26 • Number of events 3
|
|
Gastrointestinal disorders
Dyspepsia
|
4.0%
1/25 • Number of events 1
|
8.3%
2/24 • Number of events 2
|
3.8%
1/26 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.0%
2/25 • Number of events 2
|
0.00%
0/24
|
0.00%
0/26
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/25
|
8.3%
2/24 • Number of events 2
|
3.8%
1/26 • Number of events 1
|
|
General disorders
Fatigue
|
4.0%
1/25 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
15.4%
4/26 • Number of events 4
|
|
Nervous system disorders
Headache
|
8.0%
2/25 • Number of events 2
|
4.2%
1/24 • Number of events 1
|
0.00%
0/26
|
|
Psychiatric disorders
Insomnia
|
8.0%
2/25 • Number of events 2
|
8.3%
2/24 • Number of events 2
|
7.7%
2/26 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/25
|
8.3%
2/24 • Number of events 2
|
0.00%
0/26
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
4.0%
1/25 • Number of events 1
|
12.5%
3/24 • Number of events 3
|
0.00%
0/26
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/25
|
8.3%
2/24 • Number of events 2
|
0.00%
0/26
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/25
|
4.2%
1/24 • Number of events 1
|
7.7%
2/26 • Number of events 2
|
|
General disorders
Oedema peripheral
|
0.00%
0/25
|
8.3%
2/24 • Number of events 3
|
3.8%
1/26 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.0%
1/25 • Number of events 1
|
12.5%
3/24 • Number of events 4
|
7.7%
2/26 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
8.0%
2/25 • Number of events 2
|
0.00%
0/24
|
0.00%
0/26
|
|
Infections and infestations
Sinusitis
|
12.0%
3/25 • Number of events 3
|
0.00%
0/24
|
0.00%
0/26
|
|
Psychiatric disorders
Suicidal ideation
|
4.0%
1/25 • Number of events 1
|
0.00%
0/24
|
7.7%
2/26 • Number of events 2
|
|
Nervous system disorders
Tremor
|
0.00%
0/25
|
0.00%
0/24
|
7.7%
2/26 • Number of events 2
|
|
Infections and infestations
Upper respiratory track infection
|
8.0%
2/25 • Number of events 2
|
4.2%
1/24 • Number of events 1
|
0.00%
0/26
|
Additional Information
Michael A. Schwarzschild, MD, PhD
The Parkinson Study Group
Phone: 617-724-9611
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place