Trial Outcomes & Findings for The Effect of Donepezil (Aricept(Registered Trademark)) on REM Sleep in Children With Autism (NCT NCT00695136)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

17 participants

Primary outcome timeframe

1 month (from baseline to 1.25 mg dose)

Results posted on

2013-04-24

Participant Flow

Children were screened with polysomnography and 8 of 16 subjects were found to have low REM sleep% and were eligible to continue with the study. One of the 8 elected not to participate in the dose-finding drug administration.

Participant milestones

Participant milestones
Measure	Open Label Single Arm The children start by taking 1.25 mg of donepezil for 2 to 4 weeks. Those whose REM sleep increases to normal levels stay on 1.25 mg of donepezil for 8 more weeks. That ends their participation in the study. Children whose REM sleep does not increase to normal on 1.25 mg of donepezil are given a higher dose (2.5 mg) for 2 to 4 weeks. Those whose REM sleep does not increase to normal on 2.5 mg of donepezil take 5 mg of the drug for 2 to 4 weeks. Children whose REM sleep does not increase to normal on 5 mg of donepezil stop the medication and end their participation in the study.
Overall Study STARTED	7
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Open Label Single Arm The children start by taking 1.25 mg of donepezil for 2 to 4 weeks. Those whose REM sleep increases to normal levels stay on 1.25 mg of donepezil for 8 more weeks. That ends their participation in the study. Children whose REM sleep does not increase to normal on 1.25 mg of donepezil are given a higher dose (2.5 mg) for 2 to 4 weeks. Those whose REM sleep does not increase to normal on 2.5 mg of donepezil take 5 mg of the drug for 2 to 4 weeks. Children whose REM sleep does not increase to normal on 5 mg of donepezil stop the medication and end their participation in the study.
Overall Study Withdrawal by Subject	1
Overall Study unrelated adverse event	1

Baseline Characteristics

The Effect of Donepezil (Aricept(Registered Trademark)) on REM Sleep in Children With Autism

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Open Label Single Arm n=5 Participants Single group study of Donepezil Increase REM sleep percentage : Donepezil hydrochloride :
Age, Categorical <=18 years	5 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age Continuous	5.08 years STANDARD_DEVIATION 1.62 • n=99 Participants
Sex: Female, Male Female	0 Participants n=99 Participants
Sex: Female, Male Male	5 Participants n=99 Participants
Region of Enrollment United States	5 participants n=99 Participants

PRIMARY outcome

Timeframe: 1 month (from baseline to 1.25 mg dose)

Outcome measures

Outcome measures
Measure	Open Label Single Arm n=5 Participants Single group study of Donepezil Increase REM sleep percentage : Donepezil hydrochloride :
Change in Percentage of Time That Subjects With Autism Spend in REM Sleep.	9.2 percentage of REM sleep Standard Error 2.6

Adverse Events

Open Label Single Arm

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Open Label Single Arm n=7 participants at risk Single group study of Donepezil Increase REM sleep percentage : Donepezil hydrochloride :
Nervous system disorders other	14.3% 1/7 • Number of events 1

Additional Information

Susan E. Swedo, MD

Pediatrics & Developmental Neuroscience Branch, NIMH

Phone: 301-496-5323

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place