NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2071230029

Registered date:25/06/2023

A phase II study of NPC-15 on difficulty initiating sleep in patients with mild cognitive impairment

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedJapanese patients with mild cognitive impairment who has difficulty initiating sleep
Date of first enrollment01/07/2023
Target sample size120
Countries of recruitment
Study typeInterventional
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 OutcomeSleep onset latency based on actigraphy
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
Age maximum<= 84age old
GenderBoth
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 mild cognitive impairment 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 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 drive a car or 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

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
E-mail 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
E-mail motomura.tomoko@nobelpharma.co.jp
Affiliation Nobelpharma Co., Ltd.