A phase II study of NPC-15 on difficulty initiating sleep in patients with dementia

JRCT ID: jRCT2071230030

Registered date:25/06/2023

Basic Information

• Recruitment status: Recruiting
• 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
• 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

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
• 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