Unique ID issued by UMIN | UMIN000022342 |
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Receipt number | R000025741 |
Scientific Title | Neuroprotective evaluation of zonisamide in patients with Parkinson's disease, using dopamine transporter scan (DAT scan) |
Date of disclosure of the study information | 2016/06/01 |
Last modified on | 2017/08/14 22:03:48 |
Neuroprotective evaluation of zonisamide in patients with Parkinson's disease, using dopamine transporter scan (DAT scan)
Evaluation of zonisamide effects by DAT scan in patients with Parkinson's disease
Neuroprotective evaluation of zonisamide in patients with Parkinson's disease, using dopamine transporter scan (DAT scan)
Evaluation of zonisamide effects by DAT scan in patients with Parkinson's disease
Japan |
Parkinson's disease
Neurology | Adult |
Others
NO
DAT scan is an objective , non-invasively useful test for evaluation of the striatal dopamine metabolic abnormalities. The present study examines the changes of the DAT scan findings after one year in zonisamide-treated and -non-treated patients with Parkinson's disease. The comparative analysis elucidates whether zonisamide can inhibit the death of dopamine neurons.
Efficacy
Exploratory
Pragmatic
Not applicable
The specific binding ratio (SBR) on DAT scan at the first (baseline) and second [the mean (SD) of 1.2 (0.2) years later]
UPDRS part II, part III and part IV at the first (baseline) and second [the mean (SD) of 1.2 (0.2) years later]
Observational
20 | years-old | <= |
Not applicable |
Male and Female
Yale stage II and III in patients with Parkinson' disease
The present study was excluded the following 3 items.
1. Yale stage IV and V in patients with Parkinson' disease.
2. Patients with severe degree of dementia.
3. Patients interrupted zonisamide during the study.
4. Patients with iodine allergy.
30
1st name | |
Middle name | |
Last name | Ken Ikeda |
Toho University Omori Medical Center
Department of Neurology
6-11-1, Omorinishi, Otaku, Tokyo
03-3762-4151
keni@med.toho-u.ac.jp
1st name | |
Middle name | |
Last name | Ken Ikeda |
Toho University Omori Medical Center
Department of Neurology
6-11-1, Omorinishi, Otaku, Tokyo
03-3762-4151
keni@med.toho-u.ac.jp
Department of Neurology, Toho University Omori Medical Center
Sumitomo Dainippon Pharm Co. Ltd
Profit organization
NO
東邦大学医療センター大森病院(東京都)
2016 | Year | 06 | Month | 01 | Day |
Unpublished
1) SBR at endpoint decreased significantly in the non-ZNS group compared to baseline SBR in the non-ZNS group.
2) There were no significant differences between baseline and endpoint SBR in the ZNS group.
3) The change of SBR differed significantly between the ZNS group and the non-ZNS group.
4) The change rate of SBR (%) decreased significantly in the non-ZNS group compared to the ZNS group.
Completed
2016 | Year | 05 | Month | 02 | Day |
2016 | Year | 05 | Month | 17 | Day |
2017 | Year | 07 | Month | 07 | Day |
2017 | Year | 07 | Month | 12 | Day |
2017 | Year | 07 | Month | 31 | Day |
2017 | Year | 08 | Month | 07 | Day |
The patients with levodopa are divided into two groups of zonisamide-treated and non-treated patients. Zonisamide (25 mg/day) is administered at once according to Japanese usage and dose.Second DAT scan is performed in both groups at the mean (SD) of 1.2 (0.2) years after the first DAT scan. Zonisamide is not administered until second time of DAT scan in patients treated without zonisamide. Second DAT scan is performed in the earliest order of patients who underwent the first DAT scan to up to 12 months before the date of approval of the present study. Thus, prescription and non-prescription of zonisamide has been not decided arbitrarily for research purposes, Zonisamide treatment or non-treatment is determined by the appropriate decision based on the diagnosis of each attending physician. Therefore, the physicians who participate in the study can not intervene in the patient division into prescription and non-prescription of zonisamide at the start of the study.
2016 | Year | 05 | Month | 18 | Day |
2017 | Year | 08 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025741
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2017/08/08 | UMIN000022342症例データ.docx |