NCT00833690

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for phase_2 parkinson-disease

Timeline
Completed

Started Jun 2009

Longer than P75 for phase_2 parkinson-disease

Geographic Reach
1 country

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 2, 2009

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

June 5, 2014

Completed
Last Updated

June 5, 2014

Status Verified

May 1, 2014

Enrollment Period

3.5 years

First QC Date

January 27, 2009

Results QC Date

December 26, 2013

Last Update Submit

May 30, 2014

Conditions

Parkinson Disease

Keywords

Parkinson's diseaseParkinson diseasePDinosineurateuric acidcerebrospinal fluid

Outcome Measures

Primary Outcomes (3)

  • 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).

    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).

    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.

    24 months

Secondary Outcomes (36)

  • CSF Urate (All Patients)

    12 weeks

  • CSF Urate (Females)

    12 weeks

  • CSF Urate (Males)

    12 weeks

  • CSF Urate as a Proportion of Baseline Serum Urate (All Patients)

    12 weeks

  • CSF Urate as a Proportion of Baseline Serum Urate (Females)

    12 weeks

  • +31 more secondary outcomes

Study Arms (3)

[A:]

PLACEBO COMPARATOR

Placebo to produce no urate elevation

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

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

Drug: inosine

Interventions

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

[A:]
inosineDRUG

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

Also known as: hypoxanthine 9-β-D-ribofuranoside
[B:]

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

University of Southern California

Los Angeles, California, 90083, United States

Location

Eastern Connecticut Neurology Specialists, LLC

Manchester, Connecticut, 06040, United States

Location

Institute for Neurodegenerative Disorders

New Haven, Connecticut, 06510, United States

Location

Parkinson's Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, 33486, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Boston University Medical Center

Boston, Massachusetts, 02118, United States

Location

Michigan State University

East Lansing, Michigan, 48824, United States

Location

Struthers Parkinson's Center

Golden Valley, Minnesota, 55427, United States

Location

Duke University School of Medicine

Durham, North Carolina, 27705, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Butler Hospital Movement Disorder Program

Providence, Rhode Island, 02906, United States

Location

Scott & White Hospital

Temple, Texas, 76508, United States

Location

Related Publications (2)

  • 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.

    PMID: 31484712DERIVED

  • 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.

    PMID: 24366103DERIVED

Related Links

MeSH Terms

Conditions

Parkinson Disease

Interventions

Inosine

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Purine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Results Point of Contact

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

Study Officials

  • Michael A Schwarzschild, MD, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 27, 2009

First Posted

February 2, 2009

Study Start

June 1, 2009

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

June 5, 2014

Results First Posted

June 5, 2014

Record last verified: 2014-05

Locations

US(16)