Clinical TrialID 5659
Safety of Urate Elevation in Parkinson's Disease
NCT00833690
Parkinson Disease
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 5659
- Evidence Id
- 5659
- Core Evidence Id
- 5659
- Source Clinical Trial Id
- 5645
- Herb2 Clinical Trial Id
- HBCT005645
- Nct Id
- NCT00833690
- Title
- Safety of Urate Elevation in Parkinson's Disease
- Status
- Completed
- Phase
- Phase 2
- Study Result
- Yes
- Study Condition
- Parkinson Disease
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
- Intervention
- DRUG: Placebo|DRUG: inosine|DRUG: inosine
- Intervention Allocation
- Randomized
- Intervention Model
- Parallel
- Intervention Mask
- Double
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Adult, Older_Adult
- Enrollment
- 75
- Outcome Measure
- 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
- Sponsor Collaborator
- The Parkinson Study Group|Massachusetts General Hospital|Harvard School of Public Health (HSPH)|University of Rochester|Michael J. Fox Foundation for Parkinson's Research
- Funded By
- NETWORK
- Location
- University of Southern California, Los Angeles, California, 90083, United States|Eastern Connecticut Neurology Specialists, LLC, Manchester, Connecticut, 06040, United States|Institute for Neurodegenerative Disorders, New Haven, Connecticut, 06510, United States|Parkinson's Disease and Movement Disorders Center of Boca Raton, Boca Raton, Florida, 33486, United States|Rush University Medical Center, Chicago, Illinois, 60612, United States|Ochsner Clinic Foundation, New Orleans, Louisiana, 70121, United States|Massachusetts General Hospital, Boston, Massachusetts, 02114, United States|Boston University Medical Center, Boston, Massachusetts, 02118, United States|Michigan State University, East Lansing, Michigan, 48824, United States|Struthers Parkinson's Center, Golden Valley, Minnesota, 55427, United States|Duke University School of Medicine, Durham, North Carolina, 27705, United States|University of Cincinnati, Cincinnati, Ohio, 45219, United States|Cleveland Clinic, Cleveland, Ohio, 44195, United States|Oregon Health and Science University, Portland, Oregon, 97239, United States|Butler Hospital Movement Disorder Program, Providence, Rhode Island, 02906, United States|Scott & White Hospital, Temple, Texas, 76508, United States
- Other Id
- INO-PD-P2-2008
- Start Date
- 2009-06
- Primary Completion Date
- 2012-12
- Completion Date
- 2012-12
- First Posted
- 2009-02-02
- Results First Posted
- 2014-06-05
- Last Update Posted
- 2014-06-05
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT00833690
- Title Cn
- Title En
- Safety of Urate Elevation in Parkinson's Disease
- Bilingual Status
- semi_complete