Trial Outcomes & Findings for Efficacy and Tolerability of Ramelteon in Patients With Rapid Eye Movement (REM) Behavior Disorder and Parkinsonism (NCT NCT00745030)

Results Overview

Change in the frequency of RBD based on the daily sleep diaries, completed daily for the duration of the study by the study subjects' bed partners/caregivers. Data will not be analyzed. The protocol is being terminated due to low subject enrollment and recruitment.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

3 participants

Primary outcome timeframe

12 weeks

Results posted on

2024-01-09

Participant Flow

Participant milestones

Participant milestones
Measure	Ramelteon (TAK-375) 8mg Tablets Ramelteon (TAK-375) 8mg tablets	Placebo 8 mg Tablets Placebo 8 mg tablets
Overall Study STARTED	1	2
Overall Study COMPLETED	1	2
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy and Tolerability of Ramelteon in Patients With Rapid Eye Movement (REM) Behavior Disorder and Parkinsonism

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ramelteon (TAK-375) 8mg Tablets n=1 Participants Ramelteon (TAK-375) 8mg tablets	Placebo 8 mg Tablets n=2 Participants Placebo 8 mg tablets	Total n=3 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	57 years STANDARD_DEVIATION 0 • n=93 Participants	57 years STANDARD_DEVIATION 7.85 • n=4 Participants	57 years STANDARD_DEVIATION 7.85 • n=27 Participants
Sex: Female, Male Female	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants
Region of Enrollment United States	1 participants n=93 Participants	2 participants n=4 Participants	3 participants n=27 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: We had difficulties with recruitment and did not manage to recruit enough participants so no data was collected and the study was terminated.

Change in the frequency of RBD based on the daily sleep diaries, completed daily for the duration of the study by the study subjects' bed partners/caregivers. Data will not be analyzed. The protocol is being terminated due to low subject enrollment and recruitment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks

Population: We had difficulties with recruitment and did not manage to recruit enough participants so no data was collected and the study was terminated.

no participants were recruited

Outcome measures

Outcome data not reported

Adverse Events

Ramelteon (TAK-375) 8mg Tablets

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo 8 mg Tablets

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Angelica Marconi

Northwestern University

Phone: 312-503-1999

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place