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Trial Outcomes & Findings for A Trial of the Drug Donepezil for Sleep Enhancement and Behavioral Change in Children With Autism (NCT NCT01887132)

NCT ID: NCT01887132

Last Updated: 2017-09-25

Results Overview

The Nonverbal Developmental Quotient (NVDQ) was calculated from the Mullen Scales of Early Learning scores by dividing the nonverbal mental age (average of the age equivalent value for the Visual Reception and Fine Motor scores) by the chronological age in months. The NVDQ is normalized to a mean score of 100, which indicates an average normal IQ. Less than 100 is a lower than average IQ. 2 standard deviations below average is considered "impaired" IQ (approximately lower than 70).

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

Baseline and 12 months

Results posted on

2017-09-25

Participant Flow

5 participants signed consent. Only 4 started the study.

Participant milestones

Participant milestones
Measure
Open-Label Donepezil
Donepezil
Overall Study
STARTED
4
Overall Study
COMPLETED
4
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Trial of the Drug Donepezil for Sleep Enhancement and Behavioral Change in Children With Autism

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Open-Label Donepezil
n=4 Participants
Donepezil
Age, Categorical
<=18 years
4 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Age, Continuous
3.2 years
n=5 Participants
Sex: Female, Male
Female
0 Participants
n=5 Participants
Sex: Female, Male
Male
4 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
4 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=5 Participants
Race (NIH/OMB)
White
3 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Region of Enrollment
United States
4 participants
n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 12 months

The Nonverbal Developmental Quotient (NVDQ) was calculated from the Mullen Scales of Early Learning scores by dividing the nonverbal mental age (average of the age equivalent value for the Visual Reception and Fine Motor scores) by the chronological age in months. The NVDQ is normalized to a mean score of 100, which indicates an average normal IQ. Less than 100 is a lower than average IQ. 2 standard deviations below average is considered "impaired" IQ (approximately lower than 70).

Outcome measures

Outcome measures
Measure
Open-Label Donepezil
n=4 Participants
Donepezil
Nonverbal Developmental Quotient (NVDQ)
NVDQ for participant 1 at Baseline
51.61 units on a scale
Nonverbal Developmental Quotient (NVDQ)
NVDQ for participant 2 at Baseline
48.89 units on a scale
Nonverbal Developmental Quotient (NVDQ)
NVDQ for participant 3 at Baseline
58.97 units on a scale
Nonverbal Developmental Quotient (NVDQ)
NVDQ for participant 4 at Baseline
54.88 units on a scale
Nonverbal Developmental Quotient (NVDQ)
NVDQ for participant 1 at 12 mos
52.38 units on a scale
Nonverbal Developmental Quotient (NVDQ)
NVDQ for participant 2 at 12 mos
44.74 units on a scale
Nonverbal Developmental Quotient (NVDQ)
NVDQ for participant 3 at 12 mos
54.00 units on a scale
Nonverbal Developmental Quotient (NVDQ)
NVDQ for participant 4 at 12 mos
45.45 units on a scale

SECONDARY outcome

Timeframe: Baseline, 6, 12 and 18 months

REM percentage is the percentage of sleep spent in REM

Outcome measures

Outcome measures
Measure
Open-Label Donepezil
n=4 Participants
Donepezil
REM Percentage at Baseline, 6, 12 and 18 Months
REM percentage, participant 3, Baseline
19.9 percentage of sleep
REM Percentage at Baseline, 6, 12 and 18 Months
REM percentage, participant 4, Baseline
12.1 percentage of sleep
REM Percentage at Baseline, 6, 12 and 18 Months
REM percentage, participant 1, 6 mos
27.5 percentage of sleep
REM Percentage at Baseline, 6, 12 and 18 Months
REM percentage, participant 2, 6 mos
18.8 percentage of sleep
REM Percentage at Baseline, 6, 12 and 18 Months
REM percentage, participant 3, 6 mos
9.7 percentage of sleep
REM Percentage at Baseline, 6, 12 and 18 Months
REM percentage, participant 4, 6 mos
18.9 percentage of sleep
REM Percentage at Baseline, 6, 12 and 18 Months
REM percentage, participant 1, 12 mos
18.2 percentage of sleep
REM Percentage at Baseline, 6, 12 and 18 Months
REM percentage, participant 1, Baseline
17.2 percentage of sleep
REM Percentage at Baseline, 6, 12 and 18 Months
REM percentage, participant 2, Baseline
18.6 percentage of sleep
REM Percentage at Baseline, 6, 12 and 18 Months
REM percentage, participant 2, 12 mos
10.1 percentage of sleep
REM Percentage at Baseline, 6, 12 and 18 Months
REM percentage, participant 3, 12 mos
27.5 percentage of sleep
REM Percentage at Baseline, 6, 12 and 18 Months
REM percentage, participant 4, 12 mos
8.5 percentage of sleep
REM Percentage at Baseline, 6, 12 and 18 Months
REM percentage, participant 1, 18 mos
27.8 percentage of sleep
REM Percentage at Baseline, 6, 12 and 18 Months
REM percentage, participant 2, 18 mos
6 percentage of sleep
REM Percentage at Baseline, 6, 12 and 18 Months
REM percentage, participant 3, 18 mos
19.8 percentage of sleep
REM Percentage at Baseline, 6, 12 and 18 Months
REM percentage, participant 4, 18 mos
11.6 percentage of sleep

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 18 months

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6, 12 and 18 months

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, 12 and 18 months

Outcome measures

Outcome data not reported

Adverse Events

Open-Label Donepezil

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

Ashura W Buckley

National Institute of Mental Health (NIMH)

Phone: (301) 496-5190

Results disclosure agreements

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