Parkinson DiseasePhase 2SURE-PDNCT00833690

Safety of Urate Elevation in Parkinson's Disease

A Phase 2 study testing inosine in people with Parkinson Disease, run by The Parkinson Study Group at 16 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 30 years and older
Conditions the study is for: Parkinson Disease
What is being tested?: inosine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 75 participants
Where: 16 sitesUnited States
Study dates: Jun 2009to Dec 2012
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Idiopathic PD with at least two of the cardinal signs of PD (resting tremor, bradykinesia, rigidity)
Currently not taking or needing any treatment for PD other than an monoamine oxidase-B (MAO-B) inhibitor
Age 30 or older at the time of PD diagnosis
Diagnosis of PD made within past 3 years
Serum urate ≤ 5.8 mg/dL at initial screening

Who cannot join

History of kidney stones, gout, stroke, or heart attack
History of renal disease or certain cardiovascular problems within the past year
Acidic urine (pH ≤ 5.0), uric acid, or urate crystalluria at screening
Use of certain medications including co-enzyme Q, creatine, more than 50 IU of vitamin E daily, and more than 300 mg of vitamin C daily. (A standard daily multivitamin is permitted.)
Use of anti-PD and other medications targeting central nervous system dopamine transmission
Known unstable medical or psychiatric condition that may compromise participation in the study
Women who are pregnant or lactating

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

United States16 sites

Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, 33486
Massachusetts General Hospital
Boston, Massachusetts, 02114
Boston University Medical Center
Boston, Massachusetts, 02118
Rush University Medical Center
Chicago, Illinois, 60612
University of Cincinnati
Cincinnati, Ohio, 45219
Cleveland Clinic
Cleveland, Ohio, 44195
Duke University School of Medicine
Durham, North Carolina, 27705
Michigan State University
East Lansing, Michigan, 48824
Struthers Parkinson's Center
Golden Valley, Minnesota, 55427
University of Southern California
Los Angeles, California, 90083
Eastern Connecticut Neurology Specialists, LLC
Manchester, Connecticut, 06040
Institute for Neurodegenerative Disorders
New Haven, Connecticut, 06510
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Oregon Health and Science University
Portland, Oregon, 97239
Butler Hospital Movement Disorder Program
Providence, Rhode Island, 02906
Scott & White Hospital
Temple, Texas, 76508

Other trials in United States

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Dose-ranging Trial of Oral Inosine to Assess Safety and Ability to Elevate Urate in Early Parkinson's Disease

The purpose of this study is to determine the safety and tolerability of inosine and its ability to raise urate levels in blood and cerebral spinal fluid in individuals with early Parkinson disease. This will determine whether it is appropriate to proceed with a larger study of inosine's ability to modify the rate of disability progression in PD.

Read the detailed description

Background \& Rationale:

Convergent epidemiological and clinical observations have identified urate - a major antioxidant and the end product of purine metabolism in humans - as the first molecular predictor of both the risk and the progression of typical Parkinson's disease (PD). Among some 1600 early PD patients enrolled in prior clinical trials, those with baseline serum urate levels in the highest quintile (i.e., in the upper normal range) displayed a 40% slower rate of clinical (disability) progression compared to those with baseline urate at or below the median (with p<0.000001 for trend across quintiles). Similarly, amongst those who underwent serial SPECT brain scans for changes in dopamine transporter (DAT) binding, those with higher baseline serum urate levels displayed a slower rate of radiographic progression (loss of striatal DAT). Moreover, urate levels in baseline cerebrospinal fluid (CSF) samples also correlate inversely with rates of clinical progression. Although this link between urate and a slower decline in PD appears reproducible and robust, the critical question of causality remains to be answered by a well-designed clinical trial. The biological plausibility of neuroprotection by urate strengthens the rationale for expedient pursuit of a trial. The availability of established pharmacological approaches to elevating urate makes such a trial feasible. In particular, inosine, an orally bioavailable, central nervous system (CNS)-penetrant purine precursor of urate, offers a practical strategy as it can readily elevate serum urate, has been widely consumed as a nutritional supplement, and has been administered chronically in several multi-year clinical trials for multiple sclerosis. Before embarking on a neuroprotection trial of inosine for PD, careful assessment of the safety, validity and methodology of this approach in PD patients is warranted.

Specific Aims:

The main goal of the study is to determine whether inosine is suitable for phase III evaluation of its ability to modify the rate of disability progression in PD. Specific primary aims entail the determination of the safety and tolerability of oral inosine, and its ability to elevate urate levels in serum or CSF; and the selection of an optimal dosing regimen. Secondary aims entail the further optimization of a possible phase III study design.

Methods:

A placebo-controlled double-blind dose-ranging randomized trial of inosine will be conducted in early PD. Ninety untreated subjects diagnosed with idiopathic PD and with a serum urate below the population mean (~6 mg/dL) will be enrolled at 17 North American sites and randomized to one of three treatment groups (n=30): 1) placebo, 2) inosine dosed to produce a mild elevation in serum urate, and 3) inosine dosed to produce a moderate elevation. Tolerability, validity (urate elevation), dosage and symptomatic efficacy will be assessed after 12 weeks of treatment. Contingent on adequate tolerability and validity as assessed in this short-term analysis, the study will continue for 2 years total duration with 2 groups (placebo and a merged single inosine dosing group) or the original 3 to assess long-term tolerability and safety, which will focus on main known risks of urolithiasis and gouty arthritis and the theoretical risk of cardiovascular disease.

Significance:

This study will determine whether a phase III trial of inosine as a potential neuroprotectant in PD is warranted. If it is, then the present study could shorten substantially the lead time, and through optimization of key design features would enhance the likelihood of its safety and success.

Conditions: Parkinson Disease
Being tested: Placebo, inosine
Keywords: Parkinson's disease, Parkinson disease, PD, inosine, urate, uric acid, cerebrospinal fluid
Medical subject headings: Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDrug
500 mg of inactive substance per capsule; 1 to 6 capsules per day (in up to 3 divided doses) for 2 years; dosing adjusted algorithmically to parallel that in the inosine arms
inosineDrug
Also called hypoxanthine 9-β-D-ribofuranoside
500 mg of active substance per capsule; 1 to 6 capsules per day (in up to 3 divided doses) for 2 years; dosing titrated to a mildly elevated serum urate range of 6.1 - 7.0 mg/dL
inosineDrug
Also called hypoxanthine 9-β-D-ribofuranoside
500 mg of active substance per capsule; 1 to 6 capsules per day (in up to 3 divided doses) for 2 years; dosing titrated to a moderately elevated serum urate range of 7.1 - 8.0 mg/dL

Study groups in NCT00833690
Study group	Role	What they receive
[A:]	Placebo comparator	Placebo to produce no urate elevation Receives: Drug: Placebo
[B:]	Experimental	Inosine to produce a mild urate elevation 500 mg of active substance per capsule; 1 to 6 capsules per day (in up to 3 divided doses) for 2 years; dosing titrated to a mildly elevated serum urate range of 6.1 - 7.0 mg/dL Receives: Drug: inosine
[C.]	Experimental	Inosine to produce a moderate urate elevation 500 mg of active substance per capsule; 1 to 6 capsules per day (in up to 3 divided doses) for 2 years; dosing titrated to a moderately elevated serum urate range of 7.1 - 8.0 mg/dL Receives: Drug: inosine

What is being measured

The primary outcome is the main question the study is designed to answer.

Tolerability
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).
Measured: 6 months
Tolerability
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 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).
Measured: 24 months
Safety
Defined 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.
Measured: 24 months

Secondary outcomes (36)

CSF Urate (All Patients)
Urate concentration in cerebrospinal fluid (CSF)
Measured: 12 weeks
CSF Urate (Females)
Measured: 12 weeks
CSF Urate (Males)
Measured: 12 weeks
CSF Urate as a Proportion of Baseline Serum Urate (All Patients)
Although 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).
Measured: 12 weeks
CSF Urate as a Proportion of Baseline Serum Urate (Females)
Although 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).
Measured: 12 weeks
CSF Urate as a Proportion of Baseline Serum Urate (Males)
Although 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).
Measured: 12 weeks
Serum Urate
From blood sample drawn prior to enrollment
Measured: 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.
Serum Urate
From blood sample drawn prior to enrollment
Measured: Baseline Visit
Serum Urate
From blood sample drawn after taking study drug that day
Measured: Visit 01 (Week 2; 14 +/- 3 days after Baseline Visit)
Serum Urate
From blood sample drawn after taking study drug that day
Measured: Visit 02 (Week 4; 28 +/- 3 days after Baseline Visit)
Serum Urate
From blood sample drawn after taking study drug that day
Measured: Visit 03 (Week 6; 42 +/- 3 days after Baseline Visit)
Serum Urate
From blood sample drawn after taking study drug that day
Measured: Visit 04 (Week 9; 63 +/- 5 days after Baseline Visit)
Serum Urate
From blood sample drawn before taking study drug that day
Measured: Visit 05 (Week 12; 84 +/- 7 days after Baseline Visit)
Serum Urate
From blood sample drawn after taking study drug that day
Measured: Visit 06 (Month 6; 180 +/- 7 days after Baseline Visit)
Serum Urate
From blood sample drawn after taking study drug that day
Measured: Visit 07 (Month 9; 270 +/- 7 days after Baseline Visit)
Serum Urate
From blood sample drawn after taking study drug that day
Measured: Visit 08 (Month 12; 360 +/- 7 days after Baseline Visit)
Serum Urate
From blood sample drawn after taking study drug that day
Measured: Visit 09 (Month 15; 450 +/- 7 days after Baseline Visit)
Serum Urate
From blood sample drawn after taking study drug that day
Measured: Visit 10 (Month 18; 540 +/- 7 days after Baseline Visit)
Serum Urate
From blood sample drawn after taking study drug that day
Measured: Visit 11 (Month 21; 630 +/- 7 days after Baseline Visit)
Serum Urate
From blood sample drawn after taking study drug that day
Measured: Visit 12 (Month 24; 720 +/- 7 days after Baseline Visit)
Serum Urate
From blood sample drawn after taking study drug that day
Measured: End of Study Drug Visit (ESD) (Month 9-24; 263-727 days after Baseline Visit)
Serum Urate
From blood sample drawn a month after stopping study drug
Measured: Safety Visit (SV); 30 +/- 3 days following ESD or Month 24 Visit
Change in Serum Urate
Change from an Average of Baseline and Screening Visits
Measured: Visit 01 from Baseline (i.e., between -45 days and +2 weeks)
Change in Serum Urate
Change from an Average of Baseline and Screening Visits
Measured: Visit 02 from Baseline (i.e., between -45 days and +4 weeks)
Change in Serum Urate
Change from an Average of Baseline and Screening Visits
Measured: Visit 03 from Baseline (i.e., between -45 days and +6 weeks)
Change in Serum Urate
Change from an Average of Baseline and Screening Visits
Measured: Visit 04 from Baseline (i.e., between -45 days and +9 weeks)
Change in Serum Urate
Change from an Average of Baseline and Screening Visits
Measured: Visit 05 from Baseline (i.e., between -45 days and +12 weeks)
Change in Serum Urate
Change from an Average of Baseline and Screening Visits
Measured: Visit 06 from Baseline (i.e., between -45 days and +6 months)
Change in Serum Urate
Change from an Average of Baseline and Screening Visits
Measured: Visit 07 from Baseline (i.e., between -45 days and +9 months)
Change in Serum Urate
Change from an Average of Baseline and Screening Visits
Measured: Visit 08 from Baseline (i.e., between -45 days and +12 months)
Change in Serum Urate
Change from an Average of Baseline and Screening Visits
Measured: Visit 09 from Baseline (i.e., between -45 days and +15 months)
Change in Serum Urate
Change from an Average of Baseline and Screening Visits
Measured: Visit 10 from Baseline (i.e., between -45 days and +18 months)
Change in Serum Urate
Change from an Average of Baseline and Screening Visits
Measured: Visit 11 from Baseline (i.e., between -45 days and +21 months)
Change in Serum Urate
Change from an Average of Baseline and Screening Visits
Measured: Visit 12 from Baseline (i.e., between -45 days and +24 months)
Change in Serum Urate
Change from an Average of Baseline and Screening Visits
Measured: Safety Visit (SV) from Baseline (i.e., between -45 days and +760 days [+1 month after ESD Visit])
Change in Serum Urate
Change from Last Visit on Study Drug
Measured: Safety Visit (SV) from End of Study Drug Visit (ESD); i.e., between +263 and +760 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2009Dec 2012

First posted2 Feb 2009 (estimated)
Study startJun 2009
Primary completionDec 2012
Study completionDec 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 75 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00833690
Sponsor's protocol ID: INO-PD-P2-2008
Acronym: SURE-PD
Status last verified: May 2014
First submitted: 27 Jan 2009
Last updated: 5 Jun 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Schwarzschild MA, Macklin EA, Bakshi R, Battacharyya S, Logan R, Espay AJ, Hung AY, Bwala G, Goetz CG, Russell DS, Goudreau JL, Parashos SA, Saint-Hilaire MH, Rudolph A, Hare JM, Curhan GC, Ascherio A; Parkinson Study Group SURE-PD Investigators. Sex differences by design and outcome in the Safety of Urate Elevation in PD (SURE-PD) trial. Neurology. 2019 Oct 1;93(14):e1328-e1338. doi: 10.1212/WNL.0000000000008194. Epub 2019 Sep 4.
PubMed 31484712
Parkinson Study Group SURE-PD Investigators; Schwarzschild MA, Ascherio A, Beal MF, Cudkowicz ME, Curhan GC, Hare JM, Hooper DC, Kieburtz KD, Macklin EA, Oakes D, Rudolph A, Shoulson I, Tennis MK, Espay AJ, Gartner M, Hung A, Bwala G, Lenehan R, Encarnacion E, Ainslie M, Castillo R, Togasaki D, Barles G, Friedman JH, Niles L, Carter JH, Murray M, Goetz CG, Jaglin J, Ahmed A, Russell DS, Cotto C, Goudreau JL, Russell D, Parashos SA, Ede P, Saint-Hilaire MH, Thomas CA, James R, Stacy MA, Johnson J, Gauger L, Antonelle de Marcaida J, Thurlow S, Isaacson SH, Carvajal L, Rao J, Cook M, Hope-Porche C, McClurg L, Grasso DL, Logan R, Orme C, Ross T, Brocht AF, Constantinescu R, Sharma S, Venuto C, Weber J, Eaton K. Inosine to increase serum and cerebrospinal fluid urate in Parkinson disease: a randomized clinical trial. JAMA Neurol. 2014 Feb;71(2):141-50. doi: 10.1001/jamaneurol.2013.5528.
PubMed 24366103

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 5 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled, Dose-ranging Trial of Oral Inosine to Assess Safety and Ability to Elevate Urate in Early Parkinson's Disease
ClinicalTrials.gov ID: NCT00833690
Acronym / sponsor ID: SURE-PD / INO-PD-P2-2008
Conditions: Parkinson Disease
Keywords: Parkinson's disease, Parkinson disease, PD, inosine, urate, uric acid, cerebrospinal fluid
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 75 participants (actual)
Lead sponsor: The Parkinson Study GroupResearch network
Collaborators: Massachusetts General Hospital, Harvard School of Public Health (HSPH), University of Rochester, Michael J. Fox Foundation for Parkinson's Research
Study start: Jun 2009
Primary completion: Dec 2012 (actual)
Study completion: Dec 2012 (actual)
First posted: 2 Feb 2009 (estimated)
Results: Posted 5 Jun 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Background \& Rationale:

Specific Aims:

Methods:

Significance:

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
[A:]	Placebo comparator	Drug: PlaceboPlacebo to produce no urate elevation
[B:]	Experimental	Drug: inosineInosine to produce a mild urate elevation 500 mg of active substance per capsule; 1 to 6 capsules per day (in up to 3 divided doses) for 2 years; dosing titrated to a mildly elevated serum urate range of 6.1 - 7.0 mg/dL
[C.]	Experimental	Drug: inosineInosine to produce a moderate urate elevation 500 mg of active substance per capsule; 1 to 6 capsules per day (in up to 3 divided doses) for 2 years; dosing titrated to a moderately elevated serum urate range of 7.1 - 8.0 mg/dL

Who may qualify

Ages: 30 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Idiopathic PD with at least two of the cardinal signs of PD (resting tremor, bradykinesia, rigidity)
Currently not taking or needing any treatment for PD other than an monoamine oxidase-B (MAO-B) inhibitor
Age 30 or older at the time of PD diagnosis
Diagnosis of PD made within past 3 years
Serum urate ≤ 5.8 mg/dL at initial screening

Key exclusion criteria (7 listed)

History of kidney stones, gout, stroke, or heart attack
History of renal disease or certain cardiovascular problems within the past year
Acidic urine (pH ≤ 5.0), uric acid, or urate crystalluria at screening
Use of certain medications including co-enzyme Q, creatine, more than 50 IU of vitamin E daily, and more than 300 mg of vitamin C daily. (A standard daily multivitamin is permitted.)
Use of anti-PD and other medications targeting central nervous system dopamine transmission

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Placebo500 mg of inactive substance per capsule; 1 to 6 capsules per day (in up to 3 divided doses) for 2 years; dosing adjusted algorithmically to parallel that in the inosine arms	Drug	[A:]
inosineAlso: hypoxanthine 9-β-D-ribofuranoside500 mg of active substance per capsule; 1 to 6 capsules per day (in up to 3 divided doses) for 2 years; dosing titrated to a mildly elevated serum urate range of 6.1 - 7.0 mg/dL	Drug	[B:]
inosineAlso: hypoxanthine 9-β-D-ribofuranoside500 mg of active substance per capsule; 1 to 6 capsules per day (in up to 3 divided doses) for 2 years; dosing titrated to a moderately elevated serum urate range of 7.1 - 8.0 mg/dL	Drug	[C.]

Primary outcome

Tolerability
Time frame: 6 months
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).
Tolerability
Time frame: 24 months
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 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).
Safety
Time frame: 24 months
Defined 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.

36 secondary outcomes

CSF Urate (All Patients)
Time frame: 12 weeks
CSF Urate (Females)
Time frame: 12 weeks
CSF Urate (Males)
Time frame: 12 weeks
CSF Urate as a Proportion of Baseline Serum Urate (All Patients)
Time frame: 12 weeks
CSF Urate as a Proportion of Baseline Serum Urate (Females)
Time frame: 12 weeks
CSF Urate as a Proportion of Baseline Serum Urate (Males)
Time frame: 12 weeks
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.
Serum Urate
Time frame: Baseline Visit
Serum Urate
Time frame: Visit 01 (Week 2; 14 +/- 3 days after Baseline Visit)
Serum Urate
Time frame: Visit 02 (Week 4; 28 +/- 3 days after Baseline Visit)
Serum Urate
Time frame: Visit 03 (Week 6; 42 +/- 3 days after Baseline Visit)
Serum Urate
Time frame: Visit 04 (Week 9; 63 +/- 5 days after Baseline Visit)
Serum Urate
Time frame: Visit 05 (Week 12; 84 +/- 7 days after Baseline Visit)
Serum Urate
Time frame: Visit 06 (Month 6; 180 +/- 7 days after Baseline Visit)
Serum Urate
Time frame: Visit 07 (Month 9; 270 +/- 7 days after Baseline Visit)
Serum Urate
Time frame: Visit 08 (Month 12; 360 +/- 7 days after Baseline Visit)
Serum Urate
Time frame: Visit 09 (Month 15; 450 +/- 7 days after Baseline Visit)
Serum Urate
Time frame: Visit 10 (Month 18; 540 +/- 7 days after Baseline Visit)
Serum Urate
Time frame: Visit 11 (Month 21; 630 +/- 7 days after Baseline Visit)
Serum Urate
Time frame: Visit 12 (Month 24; 720 +/- 7 days after Baseline Visit)
Serum Urate
Time frame: End of Study Drug Visit (ESD) (Month 9-24; 263-727 days after Baseline Visit)
Serum Urate
Time frame: Safety Visit (SV); 30 +/- 3 days following ESD or Month 24 Visit
Change in Serum Urate
Time frame: Visit 01 from Baseline (i.e., between -45 days and +2 weeks)
Change in Serum Urate
Time frame: Visit 02 from Baseline (i.e., between -45 days and +4 weeks)
Change in Serum Urate
Time frame: Visit 03 from Baseline (i.e., between -45 days and +6 weeks)
Change in Serum Urate
Time frame: Visit 04 from Baseline (i.e., between -45 days and +9 weeks)
Change in Serum Urate
Time frame: Visit 05 from Baseline (i.e., between -45 days and +12 weeks)
Change in Serum Urate
Time frame: Visit 06 from Baseline (i.e., between -45 days and +6 months)
Change in Serum Urate
Time frame: Visit 07 from Baseline (i.e., between -45 days and +9 months)
Change in Serum Urate
Time frame: Visit 08 from Baseline (i.e., between -45 days and +12 months)
Change in Serum Urate
Time frame: Visit 09 from Baseline (i.e., between -45 days and +15 months)
Change in Serum Urate
Time frame: Visit 10 from Baseline (i.e., between -45 days and +18 months)
Change in Serum Urate
Time frame: Visit 11 from Baseline (i.e., between -45 days and +21 months)
Change in Serum Urate
Time frame: Visit 12 from Baseline (i.e., between -45 days and +24 months)
Change in Serum Urate
Time frame: Safety Visit (SV) from Baseline (i.e., between -45 days and +760 days [+1 month after ESD Visit])
Change in Serum Urate
Time frame: Safety Visit (SV) from End of Study Drug Visit (ESD); i.e., between +263 and +760 days)

Results and safety

Results posted to the registry on 5 Jun 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
[A:]Placebo	25	21
[B:]Mild	24	22
[C.]Moderate	26	26

Primary outcome: Tolerability

Time frame: 6 months. Number. Unit: percentage of participants

Measure	[A:]Placebo n = 25	[B:]Mild n = 24	[C.]Moderate n = 26
Value	96	96	100

Primary outcome: Tolerability

Time frame: 24 months. Number. Unit: percentage of participants

Measure	[A:]Placebo n = 25	[B:]Mild n = 24	[C.]Moderate n = 26
Value	86	92	96

Primary outcome: Safety

Time frame: 24 months. Number. Unit: Events

Measure	[A:]Placebo n = 25	[B:]Mild n = 24	[C.]Moderate n = 26
Value	11	2	4

36 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
[A:]Placebo	9 of 25 (36%)	18 of 25 (72%)	Not reported
[B:]Mild	2 of 24 (8.3%)	22 of 24 (91.7%)	Not reported
[C.]Moderate	4 of 26 (15.4%)	20 of 26 (76.9%)	Not reported

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Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31484712Schwarzschild MA, Macklin EA, Bakshi R, Battacharyya S, Logan R, Espay AJ, Hung AY, Bwala G, Goetz CG, Russell DS, Goudreau JL, Parashos SA, Saint-Hilaire MH, Rudolph A, Hare JM, Curhan GC, Ascherio A; Parkinson Study Group SURE-PD Investigators. Sex differences by design and outcome in the Safety of Urate Elevation in PD (SURE-PD) trial. Neurology. 2019 Oct 1;93(14):e1328-e1338. doi: 10.1212/WNL.0000000000008194. Epub 2019 Sep 4.
Derived from this study: PubMed 24366103Parkinson Study Group SURE-PD Investigators; Schwarzschild MA, Ascherio A, Beal MF, Cudkowicz ME, Curhan GC, Hare JM, Hooper DC, Kieburtz KD, Macklin EA, Oakes D, Rudolph A, Shoulson I, Tennis MK, Espay AJ, Gartner M, Hung A, Bwala G, Lenehan R, Encarnacion E, Ainslie M, Castillo R, Togasaki D, Barles G, Friedman JH, Niles L, Carter JH, Murray M, Goetz CG, Jaglin J, Ahmed A, Russell DS, Cotto C, Goudreau JL, Russell D, Parashos SA, Ede P, Saint-Hilaire MH, Thomas CA, James R, Stacy MA, Johnson J, Gauger L, Antonelle de Marcaida J, Thurlow S, Isaacson SH, Carvajal L, Rao J, Cook M, Hope-Porche C, McClurg L, Grasso DL, Logan R, Orme C, Ross T, Brocht AF, Constantinescu R, Sharma S, Venuto C, Weber J, Eaton K. Inosine to increase serum and cerebrospinal fluid urate in Parkinson disease: a randomized clinical trial. JAMA Neurol. 2014 Feb;71(2):141-50. doi: 10.1001/jamaneurol.2013.5528.
Related InfoLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael A Schwarzschild, MD, PhD principal investigator

Massachusetts General Hospital

16 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing inosine in people with Parkinson Disease, run by The Parkinson Study Group at 16 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tolerability (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00833690, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2014.