A Study of Inosine Treatment to Slow Clinical Decline in Patients with Parkinson's Disease

Overview

  • Study type

    Interventional
  • Study phase

    III
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Scottsdale/Phoenix, Arizona: 15-009186
    NCT ID: NCT02642393
    Sponsor Protocol Number: INO-PD-P3-2014

About this study

The purpose of this study is to determine whether oral inosine dosed to moderately elevate serum urate (from ≤5.7 mg/dL to 7.1-8.0 mg/dL) over 2 years slows clinical decline in early Parkinson's disease.

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria

  • Willing and able to give written informed consent and to comply with trial procedures
  • Fulfills diagnostic criteria for idiopathic Parkinson's disease with at least two cardinal signs (resting tremor, bradykinesia, rigidity) present at 2nd screening and baseline evaluations, as assessed by the site Investigator
  • Absence of current or imminent (within 90 days of enrollment) disability requiring dopaminergic therapy, as assessed by the site Investigator
  • Modified Hoehn and Yahr Scale stage 1 to 2.5 inclusive
  • Age 30 or older at the time of diagnosis
  • Diagnosis made within 3 years prior to 1st screening visit
  • Non-fasting serum urate ≤ 5.7 mg/dL at 1st screening visit
  • If the subject is female, then
    • Must be surgically sterile (hysterectomy or tubal ligation)
    • Or postmenopausal (last menstruation was two years or more prior to 2nd screening visit)
    • Or using a reliable form of contraception for 60 days or more prior to baseline visit and agreeing to continue such use for 30 days after last dose of study drug
      • Reliable forms of contraception include: abstinence; implanted, injected or oral contraceptives (birth control pills), intrauterine device in place for at least 3 months prior to baseline visit, vaginal ring with spermicide, barrier with spermicide such as male or female condom, diaphragm or cervical cap, transdermal patch, male partner with vasectomy
    • Will have a negative pregnancy test at the 2nd screening visit [Note that a urine pregnancy test will be performed at screening on all women who are not at least two years postmenopausal or surgically sterile.]

Exclusion Criteria

  • Atypical parkinsonism, including that due to drugs, metabolic disorders, encephalitis, cerebrovascular disease, normal pressure hydrocephalus, or other neurodegenerative disease
  • Dopamine transporter (DAT) brain scan without evidence of dopamine deficit
  • History of gout
  • History of uric acid or urate urolithiasis, or any recurrent urolithiasis of unknown type
  • A screening test positive for uric acid crystalluria, urine pH ≤ 5.0, or an estimated glomerular filtration rate < 60 ml/min/1.73 m2
  • History of myocardial infarction or stroke
  • Symptomatic congestive heart failure with a documented ejection fraction below 45%
  • History of severe chronic obstructive pulmonary disease
  • Mini Mental State Exam score < 25
  • Use of any anti-parkinsonian medication (including levodopa, dopamine agonists, amantadine, entacapone and the anticholinergic agents trihexyphenidyl and benztropine) other than monoamine oxidase-B inhibitors within 60 days of baseline, or in excess of 90 days
  • Change in the dosage of (or initiation of) a monoamine oxidase-B (MAO-B) inhibitor within 90 days prior to baseline, i.e., entry on a MAO-B inhibitor requires a stable dosage for the 90 days prior to baseline
  • Use of the following within 30 days prior to the baseline visit: inosine, allopurinol, febuxostat, probenecid, more than 50 IU of vitamin E daily, or more than 300 mg of vitamin C daily (though a daily standard multivitamin such as Bayer One-A-Day® or Centrum® is permissible), reserpine, methylphenidate, amphetamines, cinnarizine, monoamine oxidase-A inhibitors, tetrabenazine, neuroleptics or other dopamine blocking drugs
  • Use of the following within 90 days prior to the DAT neuroimaging screening evaluation: modafinil, armodafinil, metoclopramide, alpha-methyldopa, methylphenidate, reserpine, or amphetamine derivative
  • Unstable dosing of a thiazide -- such as hydrochlorothiazide (e.g., Esidrex), chlorothiazide (e.g., Diuril), chlorthalidone (e.g., Hygroton), indapamide (e.g., Lozol), metolazone (e.g., Zaroxolyn), which are permissible as long as the subject is on a stable dose from 1 week prior to the 1st screening visit through the baseline visit
  • Known unstable medical or psychiatric condition that may compromise participation in the study
  • Difficulty swallowing large capsules might preclude participation due to the size of the study drug capsules
  • Clinically serious abnormality in the screening visit laboratory studies or ECG, as determined by the site Investigator
  • Participation in another investigational treatment study within 30 days prior to the baseline visit
  • Known hypersensitivity or intolerability to inosine
  • Known hypersensitivity to DaTscan (either the active substance of ioflupane I-123 or to any of the excipients)

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Shyamal Mehta, M.D., Ph.D.

Open for enrollment

Contact information:

Alisa Powell

(480)301-8788

Powell.Alisa@mayo.edu