Unique ID issued by UMIN | UMIN000020527 |
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Receipt number | R000023631 |
Scientific Title | Multi-centered, placebo-controlled, double-blind, randomized clinical trial to assess the effect of oral inosine on the onset of wearing off in patients with early stage Parkinson's disease |
Date of disclosure of the study information | 2016/02/01 |
Last modified on | 2016/08/03 09:13:08 |
Multi-centered, placebo-controlled, double-blind, randomized clinical trial to assess the effect of oral inosine on the onset of wearing off in patients with early stage Parkinson's disease
Randomized clinical trial to assess the disease modifying effect of oral inosine for patients with Parkinson's disease
Multi-centered, placebo-controlled, double-blind, randomized clinical trial to assess the effect of oral inosine on the onset of wearing off in patients with early stage Parkinson's disease
Randomized clinical trial to assess the disease modifying effect of oral inosine for patients with Parkinson's disease
Japan |
Parkinson's disease
Neurology |
Others
NO
To assess the efficacy of maintaining a serum urate level between 6.0 mg/dL and 7.5 mg/dL by the use of oral inosine in retarding the progress of Parkinson's disease which is defined as the advent of wearing off in patients with early stage Parkinson's disease.
Efficacy
Exploratory
Explanatory
Phase II
Time between the first administration of the drug to the onset of wearing off
(19 item-Wearing-off questionnaire > 2)
Time taken to reach Hoehn&Yahr 3.0 or above
Score change in UPDRS
Medication of levodopa over 300
Change in SBR in DATSCAN
Change in H/M in MIBG
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
YES
Institution is not considered as adjustment factor.
YES
Central registration
2
Treatment
Food |
Inosine to maintain a serum urate level between 6.0-7.5 mg/dL for 2 years
Lactose as a placebo for 2 years
20 | years-old | <= |
Not applicable |
Male and Female
Diagnosed as having Parkinson's disease according to UK Parkinson's Disease Society Brain Bank criteria.
Within 5 years (60 months) from the start of any anti-Parkinsonism medication.
19 item-Wearing-off questionnaire <= 1 at the time of the screening visit and Visit 1.
Serum urate level <= 5.5 mg/dL in male or <= 4.2 mg/dL in female.
Age >=20 and obtained written informed consent.
A history of kidney stones, gout(or chronic arthritis), ischemic heart disease
A history of kidney failure of eGFR <= 60 at the screening visit.
Having uncontrolled hypertension which is defined as SBP>=160 or DBP >=100
Current treatment with medication which slows urate excretion, which is defined as taking diuretics, losartan, anti-tuberculosis drugs or immune-suppression agents.
Being pregnant or having an intention to become pregnant during the study period.
Other factors that investigators deem inappropriate to enroll for the trial. (e.g. Having malignancy, arthritis which is difficult to discern from gout, severe allergic history to drugs)
100
1st name | |
Middle name | |
Last name | Masahiro Nomoto |
Ehime University Graduate School of Medicine
Department of Neurology and Clinical Pharmacology
Shizugawa 454, Toon City, Ehime, Japan 791-0295
089-960-5095
nomoto@m.ehime-u.ac.jp
1st name | |
Middle name | |
Last name | Hirotaka Iwaki |
Ehime University Graduate School of Medicine
Department of Neurology and Clinical Pharmacology
Shizugawa 454, Toon City, Ehime, Japan 791-0295
089-960-5095
h-iwaki@m.ehime-u.ac.jp
Ehime University Graduate School of Medicine
Ehime University Graduate School of Medicine
NO
愛媛大学医学部附属病院(愛媛県)
2016 | Year | 02 | Month | 01 | Day |
Unpublished
Open public recruiting
2015 | Year | 10 | Month | 26 | Day |
2016 | Year | 02 | Month | 01 | Day |
2016 | Year | 01 | Month | 12 | Day |
2016 | Year | 08 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023631
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