NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs051200160

Registered date:24/03/2021

ZEAL study

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedParkinson's disease
Date of first enrollment24/03/2021
Target sample size70
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)70 patients with Parkinson's disease were allocated to Zonisamide tablets (Trelief OD tablets) 1T (25mg) or placebo 1T at a time before going to bed by randomizing soft, and the efficacy of zonisamide tablet (Trelief OD tablets) for sleep is investigated comparing the parallel-group before and after administration

Outcome(s)

Primary OutcomeObjective sleep evaluation A: The following Sleep index analyzed from sleep electroencephalograms measured within 7 days before and 28 days (+ within 2days) after administration of the study drug using a portable electroencephalograph sleep graph Sleep efficiency: Percentage of actual sleep time during sleep time (%)
Secondary OutcomeObjective sleep evaluation B: The following 6 sleep indexes analyzed from sleep electroencephalograms measured within 7 days before and 28 days (+ within 2days) after administration of the study drug using a portable electroencephalograph sleep graph Total sleep time: Time from falling asleep to final awakening (minutes) Midway awakening: Total awakening time (minutes) during sleep Initiation of sleep latency: Time from bedtime to initiation of sleep (minutes) Sleep construction 1: REM sleep / non-REM sleep ratio (%) Sleep construction 2: Deep sleep (N3) hours (minutes) REM sleep behavior disorder (REM sleep without atony, RWA) : frequency of occurrence Subjective sleep evaluation 1. PDSS-2 (Japanese version of Parkinson's disease sleep scale-2) 2. Pittsburg Sleep Questionnaire 3. REM sleep behavior disorder screening Japanese questionnaire

Key inclusion & exclusion criteria

Age minimum>= 41age old
Age maximumNot applicable
GenderBoth
Include criteria1. Patients at age of 41 years or older at the time of informed consent 2. Patients with Parkinson's disease (The use of other antiparkinson's disease drugs in addition to the levodopa-containing drugs did not work effectively) 3. Patients diagnosed with Parkinson's disease based on the International Parkinson and Movement Disorder Society (MDS) diagnostic criteria (The preganglionic dopaminergic decline in functional images does not matter) 4. Patients who have been treated with levodopa and a dopamine decarboxylase inhibitor for at least a consecutive month and responded to anti-Parkinson's drug 5. Patients with the regimen of levodopa and other anti-Parkinson's drug did not change from 2 weeks prior to participation into this study to the time of informed consent. 6. Patients with stages 1 to 4 in the Hoehn & Yahr severity classification 7. 22 points or more on the Mini-Mental State Examination (MMSE) 8. In Parkinson's disease sleep scale-2: PDSS-2 Japanese version item 1 those scored "Did you sleep well last week?" "Sometimes (2-3 times a week)" "Almost none (once a week)" "Nothing" or those who scored "Did you have a bad day at night?" "Sometimes (2-3 times a week)" "Many (4-5 times a week)" "So much (6-7 times a week)" in PDSS-2 Japanese version item 2 or those who scored 5 or more in the Japanese version of the REM sleep behavior disorder (RBD) screening questionnaire. 9. Patients who have given written consent from the patient or his / her substitute for participation in this study 10. Outpatient
Exclude criteria1. Patients who have been treated with Zonisamide within 3 months prior to obtaining informed consent 2. Patients with a history of brain surgery including deep brain stimulation surgery 3. Patients with a history of other organic cerebral disorders such as stroke and epilepsy 4. Patients with hepatic or severe renal dysfunction at less than eGFR 30 5. Patients with a history of malignant syndrome 6. Patients with a history of suicide attempts 7. Patients taking antiepileptic drugs 8. Patients taking both MAO-B inhibitors and tricyclic antidepressants 9. Patients with severe dyskinesia 10. Patients with severe mental disease 11. Women with potential and intention to become pregnant 12. Patients who meet any of the following Patients with a history of toxic epidermal necrolysis (TEN) mucocutaneous ocular syndrome (Stevens-Johnson syndrome), and erythroderma (exfoliative dermatitis) 13. Patients with a history of hypersensitivity syndrome within 5 years prior to obtaining informed consent 14. Patients with a history of interstitial pneumonia within 5 years prior to obtaining informed consent 15. Patients with a history of rhabdomyolysis within 5 years prior to obtaining informed consent 16. Patients with aplastic anemia, agranulocytosis, pure red cell aplasia, thrombocytopenia 17. Patients using a pacemaker 18. Patients with a history of hypersensitivity to the components of Zonisamide 19. Patients participating in other clinical trials 20. Other patients who the principal investigator (sharing) judges to be inappropriate

Related Information

Contact

Public contact
Name Kataoka Hiroshi
Address 840 Shijo-cho Kashihara,Nara Nara Japan 634-8522
Telephone +81-744-29-8860
E-mail hk55@naramed-u.ac.jp
Affiliation Nara Medical University Hospital
Scientific contact
Name Kataoka Hiroshi
Address 840 Shijo-cho Kashihara,Nara Nara Japan 634-8522
Telephone +81-744-22-3051
E-mail hk55@naramed-u.ac.jp
Affiliation Nara Medical University Hospital