Trial Outcomes & Findings for Treatment of Insomnia in Elderly Sleep Apnea Patients With Ramelteon (TAK 375) (NCT NCT01048242)

NCT ID: NCT01048242

Last Updated: 2023-05-25

Results Overview

Time to sleep onset as determined by polysomnography

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 27 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2023-05-25

Participant Flow

Participant milestones

Measure	Ramelteon Ramelteon 8 mg oral before bedtime	Sugar Pill
Overall Study STARTED	12	15
Overall Study COMPLETED	8	13
Overall Study NOT COMPLETED	4	2

Reasons for withdrawal

Measure	Ramelteon Ramelteon 8 mg oral before bedtime	Sugar Pill
Overall Study See study flow chart	4	2

Baseline Characteristics

Treatment of Insomnia in Elderly Sleep Apnea Patients With Ramelteon (TAK 375)

Baseline characteristics by cohort

Measure	Ramelteon n=12 Participants Ramelteon 8 mg oral before bedtime	Sugar Pill n=15 Participants	Total n=27 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants	15 Participants n=7 Participants	27 Participants n=5 Participants
Age, Continuous	73.6 years STANDARD_DEVIATION 5.6 • n=5 Participants	70.6 years STANDARD_DEVIATION 3.5 • n=7 Participants	72 years STANDARD_DEVIATION 5.6 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	15 participants n=7 Participants	27 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: analysis per protocol

Time to sleep onset as determined by polysomnography

Outcome measures

Measure	Ramelteon n=8 Participants Ramelteon 8 mg oral before bedtime	Sugar Pill n=13 Participants
Sleep Onset Latency	9.7 minutes Standard Deviation 10.3	34.4 minutes Standard Deviation 30.7

Adverse Events

Ramelteon

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Sugar Pill

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Ramelteon n=8 participants at risk Ramelteon 8 mg oral before bedtime	Sugar Pill n=13 participants at risk
Skin and subcutaneous tissue disorders Skin ulcer	12.5% 1/8 • Number of events 1	0.00% 0/13
Respiratory, thoracic and mediastinal disorders Paranasal sinusitis	12.5% 1/8 • Number of events 1	0.00% 0/13
Gastrointestinal disorders Diarrhea	12.5% 1/8 • Number of events 1	0.00% 0/13
Musculoskeletal and connective tissue disorders Fracture	12.5% 1/8 • Number of events 1	0.00% 0/13
Gastrointestinal disorders Abdominal pain	0.00% 0/8	7.7% 1/13 • Number of events 1
Gastrointestinal disorders Nausea	0.00% 0/8	7.7% 1/13 • Number of events 1

Additional Information

Nalaka Gooneratne

University of Pennsylvania

Phone: 215 349 5938

Email: ngoonera@mail.med.upenn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place