ZEAL study

JRCT ID: jRCTs051200160

Registered date:24/03/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Parkinson's disease
• Date of first enrollment: 13/04/2021
• Target sample size: 70
• Study type: Interventional
• 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 Outcome

Objective 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 Outcome

Objective 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 maximum: Not applicable
• Gender: Both

Include criteria

1. 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 criteria

1. 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 serious renal dysfunction (eGFR is 30 and less) or hepatic disfunction within 6 months prior to patient's consent
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

• Primary Sponsor: Hiroshi Kataoka
• Source(s) of Monetary Support: Sumitomo Pharma Co., Ltd