Trial Outcomes & Findings for Ramelteon for Treatment of Adult Patients With ADHD-Related Insomnia (NCT NCT00622427)

Results Overview

It is an 18 item scale with 9 symptoms of inattention and 9 symptoms of Impulsivity and Hyperactivity. This scale is the gold standard in assessment of ADHD. Scores range from 0-54. There must be a score of 6 or more in either category to be diagnosed with ADHD. Severity ranges: 6-18 mild, 19-36 moderate, 37-54 severe. The outcome measure is the percentage difference between the total day 1 score for all subjects and the total 14 day score for all subjects.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

32 participants

Primary outcome timeframe

day 1 to day 14 of study drug

Results posted on

2013-05-24

Participant Flow

Subjects were screened by medical and psychiatric history after responding to solicitation with advertisements in local newspapers and from existing clinic populations.

Participant milestones

Participant milestones
Measure	Ramelteon Then Placebo (8 mg) QD for 14 days prior to sleep first, 2 week wash out period, then placebo QD for 14 days prior to sleep	Placebo Then Ramelteon (8 mg) QD for 14 days prior to sleep first, 2 week wash out period, then Ramelteon QD for 14 days prior to sleep
Overall Study STARTED	16	16
Overall Study COMPLETED	16	16
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ramelteon for Treatment of Adult Patients With ADHD-Related Insomnia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ramelteon Then Placebo (8 mg) n=16 Participants QD for 14 days prior to sleep first, 2 week wash out period, then placebo QD for 14 days prior to sleep	Placebo Then Ramelteon (8 mg) n=16 Participants QD for 14 days prior to sleep first, 2 week wash out period, then Ramelteon QD for 14 days prior to sleep	Total n=32 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	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	10 Participants n=7 Participants	17 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants	16 participants n=7 Participants	32 participants n=5 Participants

PRIMARY outcome

Timeframe: day 1 to day 14 of study drug

It is an 18 item scale with 9 symptoms of inattention and 9 symptoms of Impulsivity and Hyperactivity. This scale is the gold standard in assessment of ADHD. Scores range from 0-54. There must be a score of 6 or more in either category to be diagnosed with ADHD. Severity ranges: 6-18 mild, 19-36 moderate, 37-54 severe. The outcome measure is the percentage difference between the total day 1 score for all subjects and the total 14 day score for all subjects.

Outcome measures

Outcome measures
Measure	Ramelteon n=32 Participants QD for 14 days prior to sleep first	Placebo n=32 Participants QD for 14 days prior to sleep first
Change in Baseline to 2 Weeks ADHD Rating Scale	0 percentage of change Standard Deviation 0	0 percentage of change Standard Deviation 0

SECONDARY outcome

Timeframe: day 1 to day 14 of study drug

The CGI is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). The outcome measure is the percent difference between the total score for all subjects at day 1 and the total score for all subjects at day 14 of the study drug.

Outcome measures

Outcome measures
Measure	Ramelteon n=32 Participants QD for 14 days prior to sleep first	Placebo n=32 Participants QD for 14 days prior to sleep first
Change in Clinical Global Impression (CGI)	0 percentage of change Standard Deviation 0	0 percentage of change Standard Deviation 0

Adverse Events

Ramelteon Then Placebo (8 mg)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo Then Ramelteon (8 mg)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ramelteon Then Placebo (8 mg) n=16 participants at risk QD for 14 days prior to sleep first, 2 week wash out period, then placebo QD for 14 days prior to sleep	Placebo Then Ramelteon (8 mg) n=16 participants at risk QD for 14 days prior to sleep first, 2 week wash out period, then Ramelteon QD for 14 days prior to sleep
Nervous system disorders Drowsiness	12.5% 2/16 • Number of events 2 • Length of study--average of 6 weeks	18.8% 3/16 • Number of events 3 • Length of study--average of 6 weeks
Skin and subcutaneous tissue disorders Hives	6.2% 1/16 • Number of events 1 • Length of study--average of 6 weeks	0.00% 0/16 • Length of study--average of 6 weeks
Nervous system disorders Dizziness	0.00% 0/16 • Length of study--average of 6 weeks	6.2% 1/16 • Number of events 1 • Length of study--average of 6 weeks

Additional Information

Rachel Fargason

University of Alabama at Birmingham

Phone: 205-934-5151

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place