JRCT ID: jRCT2071230030
Registered date:25/06/2023
A phase II study of NPC-15 on difficulty initiating sleep in patients with dementia
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | Japanese patients with dementia who has difficulty initiating sleep |
Date of first enrollment | 01/07/2023 |
Target sample size | 120 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | (Screening period) A total of 3 tablets of 1 tablet of NPC-15 1.25 mg placebo and 2 tablets of NPC-15 2.5 mg placebo are orally administered 30 minutes before bedtime once daily. (Randomized period) A total of 3 tablets of the following treatment group allocated using dynamic allocation method are orally administered 30 minutes before bedtime once daily. - NPC-15 1.25 mg Group:1 tablet of NPC-15 1.25 mg and 2 tablets of NPC-15 2.5 mg placebo - NPC-15 2.5 mg Group:1 tablet of NPC-15 2.5 mg, 1 tablet of NPC-15 1.25 mg placebo and 1 tablet of NPC-15 2.5 mg placebo - NPC-15 5 mg Group:2 tablets of NPC-15 2.5 mg and 1 tablet of NPC-15 1.25 mg placebo - Placebo Group:1 tablet of NPC-15 1.25 mg placebo and 2 tablets of NPC-15 2.5 mg placebo |
Outcome(s)
Primary Outcome | Sleep onset latency based on actigraphy |
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Secondary Outcome | - Sleep parameters on actigraphy (total sleep time, sleep efficiency, number of arousals and wake time after sleep onset) - Grand total score based on MMSE |
Key inclusion & exclusion criteria
Age minimum | >= 60age old |
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Age maximum | <= 84age old |
Gender | Both |
Include criteria | (1) A patient aged from 60 to 84 years at the time of obtaining informed consent. (2) A patient who meets diagnostic criteria for dementia in DSM-5. (3) A patient whose usual averaged sleep onset latency (time to falling asleep from bedtime) of 30 minutes or longer continues for 3 months or longer at the time of informed consent. (4) A patient who is able to visit the hospital as scheduled. (5) A patient is an outpatient. (6) A patient who participates in the study voluntarily, and gives written informed consent. |
Exclude criteria | (1) A patient who has a past history to ingest melatonin including its supplements for more than 1 week. (2) A patient who has a past history of hypersensitivity or allergy to melatonin or ramelteon. (3) A patient who has hepatic dysfunction (AST>100 U/L or ALT>100 U/L). (4) A patient who has received prohibited concomitant medications (including OTC drugs or supplements for melatonin) or has started to receive instructions/therapies for improving sleep within 4 weeks prior to the start of the Screening period, or requires those medications or the start of those during the study period. (5) A patient who has started to receive restricted concomitant medications or restricted therapies (cognitive behavioral therapy or bright light therapy) within 4 weeks prior to the start of the Screening period, or is scheduled to start such medications or treatments during the study period. (6) A patient who is not able to refrain from ingesting beverage containing caffeine (up to 3 cans/cups a day) and alcoholic beverage (up to around 180 mL of Japanese sake or equivalent a day) (7) A patient who is scheduled to have stay out overnight during the study period. (8) A patient who needs to operate dangerous machinery during the study period. (9) A patient who has participated in a clinical study or post marketing clinical study and received the study drug (including placebo) or participated in a clinical study or post marketing clinical study for medical devices within 4 months prior to the start of the Screening period. (10) A patient who has participated in a clinical investigation involving invasive examinations within 4 months prior to the start of the Screening period. (11) A female patient who is presently pregnant or breast-feeding, or willing to be pregnant and not to consent to contraception between the informed consent and completion of the study. (12) A patient who is receiving fluvoxamine maleate or may receive the drug during the study period. (13) A patient who has a significant disease or findings to be inappropriate to participate in the study according to the opinion of the investigator or sub-investigator. |
Related Information
Primary Sponsor | Motomura Tomoko |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) |
Contact
Public contact | |
Name | Tomoko Motomura |
Address | NMF Kayabacho Bldg., 1-17-24, Shinkawa, Chuo-ku, Tokyo Tokyo Japan 104-0033 |
Telephone | +81-3-6670-3810 |
motomura.tomoko@nobelpharma.co.jp | |
Affiliation | Nobelpharma Co., Ltd. |
Scientific contact | |
Name | Tomoko Motomura |
Address | NMF Kayabacho Bldg., 1-17-24, Shinkawa, Chuo-ku, Tokyo Tokyo Japan 104-0033 |
Telephone | +81-3-6670-3810 |
motomura.tomoko@nobelpharma.co.jp | |
Affiliation | Nobelpharma Co., Ltd. |