Study on efficacy and safety of zonisamide in at-risk subjects of Lewy body disease

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-jRCTs041190126
• Date of registration: 10/03/2020
• Prospective Registration: Yes
• Primary sponsor: Katsuno Masahisa
• Public title: Study on efficacy and safety of zonisamide in at-risk subjects of Lewy body disease
• Scientific title: Study on efficacy and safety of zonisamide in at-risk subjects of Lewy body disease - NaT-PROBEi
• Date of first enrolment: 22/02/2021
• Target sample size: 30
• Recruitment status: Not Recruiting
• URL: https://jrct.niph.go.jp/latest-detail/jRCTs041190126
• Study type: Interventional
• Study design: randomized controlled trial, double blind, placebo control, parallel assignment, treatment purpose
• Phase: 2

Contacts

• Name: Masahisa Katsuno
• Affiliation: Nagoya University Graduate School of Medicine

• Name: Keita Hiraga
• Affiliation: Nagoya University Graduate School of Medicine

Key inclusion & exclusion criteria

Inclusion criteria: 1. Subjects whose age is between 50 and 80 years old
2. Subjects who have two or more prodromal symptoms:
SCOPA-AUT: 10 or more
RBDSQ: 5 or more, or REM sleep without atonia (RWA) finding of polysomnography
OSIT-J: 7 or less, or SAOQ: 90% or less
3. Subjects who fulfill one of the following criteria:
In cardiac MIBG scintigraphy, H/M ratio is less than 2.2 in early-phase and/or delayed-phase
In DaT SPECT, SBR is lower than the limit of z-score for each age using DaTVIEW analysis (left and/or right side), or DAT deficiency in the striatum
4. Subjects who can make an outpatient visit regularly
5. Subjects who agree to participate in this study
Exclusion criteria: 1. Subjects who received zonisamide within 4 weeks from screening
2. Subjects with hypersensitivity to TRERIEF
3. Subjects who take medicine which affect blood concentration of zonisamide: strong inhibitors of CYP3A
4. Subjects with severe heart disease (myocardial infarction, angina, etc)
5. Subjects with severe hepatic or renal dysfunction
6. Subjects diagnosed with Parkinson's disease or dementia with Lewy body
7. Subjects with mental or neurological disorders other than depression
8. Subjects with other severe complications
9. Female subjects who are pregnant or breast-feeding, those with positive urine hCG pregnancy test
10. Subjcets who disagree with contraception during the study period
11. Subjects diagnosed with dementia or other neurological disorders using brain MRI at screening
12. Subjects who are inappropriate to participate in the study
13. Subjects who received other investigational drugs within 1 year
14. Subjects who participate in other clinical trials. Prospective study on early diagnosis of Parkinson's disease in medical checkup examinees with non-motor symptoms (NaT-PROBE) is excluded.

Age minimum: >= 50age old
Age maximum: < 80age old
Gender: Both

Health Condition(s) or Problem(s) studied

Lewy body disease (Parkinson's disease and dementia with Lewy bodies)

Intervention(s)

Arm zonisamide:
1.Two tablets of zonisamide 25mg after breakfast for 4 weeks
2.Four tablets of zonisamide 25mg after breakfast for 92 weeks
Arm placebo:
1.Two tablets of placebo after breakfast for 4 weeks
2.Four tablets of placebo after breakfast for 92 weeks

Primary Outcome(s)

Change of the average of SBR in the right and left sides in DaT SPECT from week 0

Secondary Outcome(s)

1. Change of the following measures from 0 week:
Change of SBR of each side in DaT SPECT
MDS-UPDRS
MoCA-J
Trail making test
Stroop test
Line orientation test
pareidolia test
H/M ratio on cardiac MIBG scintigraphy
OSIT-J
Schellong test
CVR-R on electrocardiogram
PASE
SCOPA-AUT-J
RBDSQ-J
PDQ-39
BDI-II
SAOQ
JESS
QUIP-Current-Short
2. Subjects who fulfill the diagnostic criteria for Parkinson's disease or dementia with Lewy bodies

Source(s) of Monetary Support

Sumitomo Pharma Co., Ltd.

Secondary Sponsor(s)

Japan Agency for Medical Research and Development

Ethics review

Status: Approval
Approval date: 18/02/2020
Contact:

[e-mail]

Nagoya University Clinical Research Review Board

[phone]

[e-mail]