Trial Outcomes & Findings for Ramelteon for a Nap Prior to a Night Shift (NCT NCT00595075)

Results Overview

total sleep time/time in bed \* 100% (higher values indicate better outcome)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

11 participants

Primary outcome timeframe

2 hours

Results posted on

2012-10-30

Participant Flow

Healthy volunteers were recruited

Participants received 1 dose of ramelteon or placebo during the first inpatient visit and then returned approximately four weeks later for the other condition, counterbalanced for order

Participant milestones

Participant milestones
Measure	Ramelteon in First Crossover Period Ramelteon 8 mg will be given prior to a 2-hour nap	Placebo in First Crossover Period Placebo will be given prior to a 2-hour nap
Overall Study STARTED	6	5
Overall Study COMPLETED	5	5
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Ramelteon in First Crossover Period Ramelteon 8 mg will be given prior to a 2-hour nap	Placebo in First Crossover Period Placebo will be given prior to a 2-hour nap
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Ramelteon for a Nap Prior to a Night Shift

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ramelteon in First Crossover Period n=6 Participants Ramelteon 8 mg will be given prior to a 2-hour nap	Placebo in First Crossover Period n=5 Participants Placebo will be given prior to a 2-hour nap	Total n=11 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	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	22.7 years STANDARD_DEVIATION 4.1 • n=5 Participants	26.8 years STANDARD_DEVIATION 3.2 • n=7 Participants	24.5 years STANDARD_DEVIATION 4.1 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants	5 participants n=7 Participants	11 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 hours

Population: All participants that completed both crossover periods

total sleep time/time in bed \* 100% (higher values indicate better outcome)

Outcome measures

Outcome measures
Measure	Ramelteon n=10 Participants Ramelteon 8 mg will be given prior to a 2-hour nap	Placebo n=10 Participants Placebo will be given prior to a 2-hour nap
Sleep Efficiency	89.1 percent Standard Deviation 9.8	83.3 percent Standard Deviation 14.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 71 minutes

Population: All participants that completed both crossover periods

numerical scale of increasing alertness from 0-100 (higher values are better outcome)

Outcome measures

Outcome measures
Measure	Ramelteon n=10 Participants Ramelteon 8 mg will be given prior to a 2-hour nap	Placebo n=10 Participants Placebo will be given prior to a 2-hour nap
Post-nap Assessment - Visual Analog Scale	61.1 units on a scale Standard Deviation 18.6	67.1 units on a scale Standard Deviation 22.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 71 minutes

Population: All participants that completed both crossover periods

numerical scale of increasing sleepiness from 1-9 (higher values indicate worse outcome)

Outcome measures

Outcome measures
Measure	Ramelteon n=10 Participants Ramelteon 8 mg will be given prior to a 2-hour nap	Placebo n=10 Participants Placebo will be given prior to a 2-hour nap
Post Nap Assessment - Karolinska Sleepiness Scale	5.4 units on a scale Standard Deviation 1.6	4.8 units on a scale Standard Deviation 1.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 71 minutes

Population: All participants that completed both crossover periods

A cognitive throughput task consisting of matching symbols to numerical keys; higher numbers indicate a better score

Outcome measures

Outcome measures
Measure	Ramelteon n=10 Participants Ramelteon 8 mg will be given prior to a 2-hour nap	Placebo n=10 Participants Placebo will be given prior to a 2-hour nap
Post Nap Assessment - Digit Symbol Substitution Test (Correct Answers)	50.4 correct answers Standard Deviation 9.3	53.3 correct answers Standard Deviation 9.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 71 minutes

Population: All participants completing both crossover periods

EEG spectral analysis of 5.5-9.0 Hz frequency activity (theta low-frequency alpha), with higher activity indicating increased drowsiness and worse outcome

Outcome measures

Outcome measures
Measure	Ramelteon n=10 Participants Ramelteon 8 mg will be given prior to a 2-hour nap	Placebo n=10 Participants Placebo will be given prior to a 2-hour nap
Post Nap Assessment - Karolinska Drowsiness Test	4.9 microvolts^2/Hz Standard Deviation 4.5	4.0 microvolts^2/Hz Standard Deviation 5.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 hours

Population: All participants completing both crossover periods

Visual-motor reaction time in which participants hit a button on a response box as fast as possible in response to a visual target (lower values indicate better outcome)

Outcome measures

Outcome measures
Measure	Ramelteon n=10 Participants Ramelteon 8 mg will be given prior to a 2-hour nap	Placebo n=10 Participants Placebo will be given prior to a 2-hour nap
Psychomotor Vigilance Task - Median Reaction Time	0.662 seconds Standard Deviation 0.16	0.362 seconds Standard Deviation 0.25

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 hours

Population: All participants completing both crossover periods

Number of trials per test battery with a reaction time \>0.5 seconds (higher values indicate worse outcome)

Outcome measures

Outcome measures
Measure	Ramelteon n=10 Participants Ramelteon 8 mg will be given prior to a 2-hour nap	Placebo n=10 Participants Placebo will be given prior to a 2-hour nap
Psychomotor Vigilance Task - Number of Lapses	15.5 lapses Standard Deviation 16.3	13.2 lapses Standard Deviation 16.0

Adverse Events

Ramelteon

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Daniel Cohen

Sentara Neurology Specialists

Phone: 757-388-6323

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60