Trial Outcomes & Findings for Functional Melatonin Replacement for Sleep Disruptions in Individuals With Tetraplegia (NCT NCT00507546)

Results Overview

Measured as the median of the average WASO of the three weeks of either placebo or ramelteon treatment

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

12 participants

Primary outcome timeframe

10 weeks

Results posted on

2014-05-22

Participant Flow

Subjects recruited from community

Subjects excluded if baseline measure detected the presence of melatonin metabolite in their urine.

Participant milestones

Participant milestones
Measure	Arm 1 Ramelteon then placebo Ramelteon : 8 mg nightly	Arm 2 Placebo then ramelteon Placebo : Nightly 8mg of placebo (same appearance as ramelteon)
Overall Study STARTED	4	4
Overall Study COMPLETED	2	3
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm 1 Ramelteon then placebo Ramelteon : 8 mg nightly	Arm 2 Placebo then ramelteon Placebo : Nightly 8mg of placebo (same appearance as ramelteon)
Overall Study Withdrawal by Subject	1	0
Overall Study Protocol Violation	1	0
Overall Study Physician Decision	0	1

Baseline Characteristics

Functional Melatonin Replacement for Sleep Disruptions in Individuals With Tetraplegia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1 n=4 Participants Ramelteon then placebo Ramelteon : 8 mg nightly	Arm 2 n=4 Participants Placebo then ramelteon Placebo : Nightly 8mg of placebo (same appearance as ramelteon)	Total n=8 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	4 Participants n=5 Participants	4 Participants n=7 Participants	8 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	51.25 years STANDARD_DEVIATION 9.74 • n=5 Participants	55.5 years STANDARD_DEVIATION 15.5 • n=7 Participants	53 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants	4 participants n=7 Participants	8 participants n=5 Participants

PRIMARY outcome

Timeframe: 10 weeks

Population: All participants who completed the entire protocol.

Measured as the median of the average WASO of the three weeks of either placebo or ramelteon treatment

Outcome measures

Outcome measures
Measure	Ramelteon n=3 Participants Ramelteon then placebo Ramelteon : 8 mg nightly	Placebo n=2 Participants Placebo then ramelteon Placebo : Nightly 8mg of placebo (same appearance as ramelteon)
Amount of Wakefulness After Sleep Onset (WASO)	72.3 Minutes Interval 20.7 to 92.3	76.5 Minutes Interval 24.0 to 117.0

SECONDARY outcome

Timeframe: 10 weeks

Measured as the median of the average morning alertness (measured from 1-7 on the Stanford Sleepiness Scale, a Likert-like scale in which higher values are lower alertness) of the three weeks of either placebo or ramelteon treatment

Outcome measures

Outcome measures
Measure	Ramelteon n=3 Participants Ramelteon then placebo Ramelteon : 8 mg nightly	Placebo n=2 Participants Placebo then ramelteon Placebo : Nightly 8mg of placebo (same appearance as ramelteon)
Change in Subjective Morning Alertness	2.86 units on a scale Interval 2.05 to 3.57	3.14 units on a scale Interval 1.15 to 5.83

Adverse Events

Arm 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 2

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

Dr. Jamie Zeitzer

VAPAHCS

Phone: 6504935000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place