Unique ID issued by UMIN | UMIN000024859 |
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Receipt number | R000028608 |
Scientific Title | Effectiveness of switching from dopamine agonists to zonisamide or combining with zonisamide on psychiatric and motor symptoms in patients with Parkinson's disease |
Date of disclosure of the study information | 2016/11/16 |
Last modified on | 2022/02/01 13:58:25 |
Effectiveness of switching from dopamine agonists to zonisamide or combining with zonisamide on psychiatric and motor symptoms in patients with Parkinson's disease
Effectiveness of switching from dopamine agonists to zonisamide or combining with zonisamide on psychiatric and motor symptoms in patients with Parkinson's disease
Effectiveness of switching from dopamine agonists to zonisamide or combining with zonisamide on psychiatric and motor symptoms in patients with Parkinson's disease
Effectiveness of switching from dopamine agonists to zonisamide or combining with zonisamide on psychiatric and motor symptoms in patients with Parkinson's disease
Japan |
Parkinson's disease
Neurology | Adult |
Others
NO
Evaluation the effectiveness of reducing or discontinuing dopamine agonists (DAs) and adding zonisamide on motor and psychiatric symptoms in patients with Parkinson's disease who taking levodopa and had hallucinations and/or delusions considered to be attributed to use of DAs.
Efficacy
Exploratory
Pragmatic
Not applicable
Changes in the Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part 3 (motor symptoms) and MDS-UPDRS Part 1.2 (hallucinations and psychosis) scores after 12 weeks from baseline
1) Changes in the MDS-UPDRS Part 1 (non-motor symptoms except Part 1.2) , MDS-UPDRS Part 2 (motor aspects), and MDS-UPDRS Part 4 (motor complications) scores from baseline
2) Change in the Beck Depression Inventory-II (BDI-II, depression) score from baseline
3) Change in the Japanese version of the Epworth Sleepiness Scale (JESS, sleepiness) total score from baseline
4) Change in the Mini-Mental State Examination (MMSE, cognitive function) score from baseline
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
ļ½„Reducing or discontinuing DAs and adding zonisamide.
ļ½„Intervention period: 12 weeks.
30 | years-old | <= |
Not applicable |
Male and Female
1)Patients with Parkinson's disease who taking a levodopa-containing medication and DAs, and have hallucinations and/or delusions (MDS-UPDRS Part 1.2 score>=2)
2)Patients aged 30 years or older at the time of informed consent
3)Patients who have personally given voluntary written informed consent to participation in the study
1)Patients who have taken zonisamide within 6 months from the start of the study
2)Patients with cognitive impairment (MMSE score =< 23)
3)Patients who have undergone surgical therapy for parkinsonism, including stereotactic neurosurgery
4)Pregnant or possibly pregnant women, women of childbearing potential who do not agree to use appropriate contraceptive measures, or breast-feeding women
5)Patients who, in the opinion of the investigator or other study personnel, are unsuitable for the study
50
1st name | Takashi |
Middle name | |
Last name | Abe |
Medical Corporation Abe Neurology Clinic
Neurology
020-0878
6-6 Sakana-machi, Morioka-city,Iwate, Japan
019-606-3711
ryuabe@crest.ocn.ne.jp
1st name | Keigo |
Middle name | |
Last name | Nakajima |
EP-CRSU Co. Ltd.
Clinical Business Operation Headquarters Clinical Research Management Center
162-0814
Acropolis TOKYO Bldg. 3F, 6-29 Shinogawamachi, Shinjuku-ku, Tokyo, Japan
03-5684-7809
TRF@eps.co.jp
Medical Corporation Abe Neurology Clinic
Sumitomo Dainippon Pharma Co., Ltd.
Profit organization
Joint Ethical Review Board
Sanyokochi Bld.3F, 1-14 Minamikubo, Kochi-shi, Kochi, 781-0087, Japan
042-648-5551
godou-irb@eps.co.jp
NO
2016 | Year | 11 | Month | 16 | Day |
Published
https://www.neurology-jp.org/Journal/public_pdf/061070449.pdf
11
MDS-UPDRS Part 3, and Part 1.2 scores at week 12 were significantly lower than those at the baseline.
2022 | Year | 02 | Month | 01 | Day |
Delay expected |
Results delayed because additional analysis was performed to discuss the results of this study.
2021 | Year | 07 | Month | 01 | Day |
The baseline characteristics of the 11 participants were as follows:
All participants were treated with zonisamide 25 mg. The age was 73.5 +- 8.1 years old (mean +- SD), ten of them were over 65 years old. One participant was a male.
The duration of Parkinson's disease was 8.0 +- 6.3 years, the score of the MDS-UPDRS Part 1.2 and Part 3 at baseline were 2.7 +- 0.5 and 31.5 +- 7.2, respectively.
The dose-reduced or discontinued DAs were as follows: ropinirole hydrochloride: 7 patients, rotigotine: 3 patients, pramipexole: 1 patient. After 12 weeks, 5 patients discontinued DAs and 6 patients reduced their dose of DAs.
About the status of the usage of concomitant antiparkinsonian drugs except for levodopa and DAs, 2 participants were treated with entacapone, 2 were treated with istradefylline and 1 was treated with selegiline hydrochloride.
Eleven patients were registered in this study. All participants were completed the study; therefore, all participants were included to "Full analysis set".
One adverse event (Bronchitis: no causal relationship to the study drugs) was observed. No severe adverse event or discontinuation of zonisamide administration was observed.
Primary endpoint:
The changes in the MDS-UPDRS Part 1.2 and Part 3 scores after 12 weeks from baseline were -2.4 +- 0.2 and -5.1 +- 0.9 (least squares mean +- standard error), respectively, with the score reductions being statistically significant.
Secondary endpoint:
The scores of the MDS-UPDRS Part 1, Part 1 (excluding Part 1.2) after 12 weeks were significantly lower than the baseline scores. On the other hand, the scores of MDS-UPDRS Part 2, Part 4, BDI-II, JESS and MMSE at week 12 showed no significant change from the baseline, respectively.
No
No
Completed
2016 | Year | 08 | Month | 23 | Day |
2016 | Year | 09 | Month | 16 | Day |
2016 | Year | 12 | Month | 14 | Day |
2018 | Year | 08 | Month | 18 | Day |
2018 | Year | 11 | Month | 12 | Day |
2018 | Year | 11 | Month | 22 | Day |
2020 | Year | 02 | Month | 20 | Day |
An additional analysis was performed to discuss the research results (without changing research objectives).
The Ethics Review Committee approved to perform the additional analysis.
2016 | Year | 11 | Month | 16 | Day |
2022 | Year | 02 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028608
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