Unique ID issued by UMIN | UMIN000020562 |
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Receipt number | R000023741 |
Scientific Title | Clinical efficacy and safety of istradefylline in the treatment of advanced Parkinson's disease: a retrospective study |
Date of disclosure of the study information | 2016/01/14 |
Last modified on | 2017/08/02 13:45:41 |
Clinical efficacy and safety of istradefylline in the treatment of advanced Parkinson's disease: a retrospective study
Clinical efficacy and safety of istradefylline in the treatment of advanced Parkinson's disease: a retrospective study
Clinical efficacy and safety of istradefylline in the treatment of advanced Parkinson's disease: a retrospective study
Clinical efficacy and safety of istradefylline in the treatment of advanced Parkinson's disease: a retrospective study
Japan |
Parkinson's disease
Neurology |
Others
NO
To evaluate clinical efficacy and safety of istradefylline in patients with advanced Parkinson's disease in a retrospective manner
Efficacy
Clinical Global Impression-Improvement(CGI-I)
Improvement for each motor symptom
Safety
Observational
20 | years-old | <= |
Not applicable |
Male and Female
・Patients who received istradefylline in the period from May 2013 to May 2015
・Parkinson's disease patients having wearing-off phenomenon under treatment with medications containing levodopa
・Outpatient
・Patients who have moderate or severer hepatic disorder or are receiving strong CYP3A4 inhibitors.
・Women who are lactating or pregnant or are suspected of being pregnant.
50
1st name | |
Middle name | |
Last name | Yasuto Higashi |
Himeji Central Hospital
Neurology
2-36, Miyake, Shikama-ku, Himeji-city, Hyogo-pref
079-235-7331
yasuto@mvj.biglobe.ne.jp
1st name | |
Middle name | |
Last name | Yasuto Higashi |
Himeji Central Hospital
Neurology
2-36, Miyake, Shikama-ku, Himeji-city, Hyogo-pref
079-235-7331
yasuto@mvj.biglobe.ne.jp
Himeji Central Hospital
Kyowa Hakko Kirin Co., Ltd
Profit organization
NO
2016 | Year | 01 | Month | 14 | Day |
Published
Of 53 patients evaluable for efficacy, 41.5% (n=22) were minimally improved and 17.0% (n=9) much improved on CGI-I scale, accounting for 58.5% of minimally improved + much improved.
Proportion of patients with minimally improved + much improved was 48.1% (13/27 patients) and 69.2% (18/26 patients) in those on a maintenance dose of 20 mg and 40 mg of istradefylline, respectively.
Regarding each motor symptom, significant improvement was observed for gait disorder (47.9%) and postural disorder (43.3%).
Adverse events were reported in 15 of 65 patients (23.1%).
Completed
2015 | Year | 05 | Month | 31 | Day |
2015 | Year | 05 | Month | 31 | Day |
Clinical efficacy (Clinical Global Impression-Improvement and improvement for each motor symptom) and safety after treatment with istradefylline were evaluated in a retrospective manner
2016 | Year | 01 | Month | 14 | Day |
2017 | Year | 08 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023741
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