Trial Outcomes & Findings for Effects of Evening Dose of Immediate Release Methylphenidate on Sleep in Children With ADHD (NCT NCT02638168)

NCT ID: NCT02638168

Last Updated: 2019-09-17

Results Overview

Sleep onset latency is defines as duration of time in bed until sleep, as reported on the parent completed sleep log

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 3 participants
• Primary outcome timeframe: 3 weeks
• Results posted on: 2019-09-17

Participant Flow

Participant milestones

Measure	Immediate Release Methylphenidate With-in subjects trial. Subjects will be randomized to 0.3 mg/kg of Immediate Release Methylphenidate versus placebo over 3-weeks duration Immediate Release Methylphenidate: The medication assessment procedure will be a double-blind, within-subject evaluation of placebo and matching evening dose of IR MPH rounded to the nearest 2.5mg increment with a max IR MPH dose of 0.3mg/kg. Expected evening dose range will be from 2.5mg to 20mg with most participants receiving between 5 to 15mg per evening dose. Dose will be determined based on current dose of their morning extended release stimulant	Placebo inert placebo ingredient Placebo: inert placebo ingredient We have total 6 screening and recruited 3 patients for this study
Overall Study STARTED	3	0
Overall Study COMPLETED	3	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Evening Dose of Immediate Release Methylphenidate on Sleep in Children With ADHD

Baseline characteristics by cohort

Measure	With-in Subjects Trial n=3 Participants Subjects were randomized to 0.3 mg/kg Immediate Release Methylphenidate va placebo over 3-weeks duration
Age, Continuous	8.3 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	1 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	0 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

PRIMARY outcome

Timeframe: 3 weeks

Sleep onset latency is defines as duration of time in bed until sleep, as reported on the parent completed sleep log

Outcome measures

Measure	With-in Subjects Trial n=3 Participants Subjects were randomized to 0.3 mg/kg Immediate Release Methylphenidate va placebo over 3-weeks duration
Sleep Onset Latency (SOL) as Reported on the Parent Completed Sleep Log	61.04 minutes Interval 23.1 to 114.51

SECONDARY outcome

Timeframe: 3 weeks

Sleep onset latency is defines as duration of time in bed until sleep actigraphy

Outcome measures

Measure	With-in Subjects Trial n=3 Participants Subjects were randomized to 0.3 mg/kg Immediate Release Methylphenidate va placebo over 3-weeks duration
Sleep Onset Latency (SOL), Defined as Time in Bed Until Sleep by Actigraphy	37.81 minutes Interval 0.0 to 95.0

SECONDARY outcome

Timeframe: 3 weeks

Pittsburgh Side Effects Rating Scale to evaluate adverse reactions to Methylphenidate Higher scores mean a worse outcome (more side effects with medication) This scales has 13 items, which are reported as None (0), Mild (1), Moderate (2) and Severe (3) Total score is calculated by summiting all items. Total Score Ranges (0-39)

Outcome measures

Measure	With-in Subjects Trial n=3 Participants Subjects were randomized to 0.3 mg/kg Immediate Release Methylphenidate va placebo over 3-weeks duration
Pittsburgh Side Effects Rating Scale	3.66 score on a scale Interval 3.0 to 5.0

SECONDARY outcome

Timeframe: 3 weeks

Outcome measures

Measure	With-in Subjects Trial n=3 Participants Subjects were randomized to 0.3 mg/kg Immediate Release Methylphenidate va placebo over 3-weeks duration
Sleep Offset	604 minutes Interval 580.0 to 675.0

SECONDARY outcome

Timeframe: 3 weeks

Outcome measures

Measure	With-in Subjects Trial n=3 Participants Subjects were randomized to 0.3 mg/kg Immediate Release Methylphenidate va placebo over 3-weeks duration
Total Sleep Time	492.45 minutes Interval 432.0 to 585.0

SECONDARY outcome

Timeframe: 3 weeks

Outcome measures

Measure	With-in Subjects Trial n=3 Participants Subjects were randomized to 0.3 mg/kg Immediate Release Methylphenidate va placebo over 3-weeks duration
Wake After Sleep Onset (WASO)	73.81 minutes Interval 29.0 to 147.0

SECONDARY outcome

Timeframe: 3 weeks

Outcome measures

Measure	With-in Subjects Trial n=3 Participants Subjects were randomized to 0.3 mg/kg Immediate Release Methylphenidate va placebo over 3-weeks duration
Sleep Efficiency	81.45 percentage of time spent asleep in bed Interval 72.61 to 89.14

SECONDARY outcome

Timeframe: 3 weeks

Outcome measures

Measure	With-in Subjects Trial n=3 Participants Subjects were randomized to 0.3 mg/kg Immediate Release Methylphenidate va placebo over 3-weeks duration
Number of Wakings	22.81 Wakings Interval 15.0 to 33.0

SECONDARY outcome

Timeframe: 3 weeks

Outcome measures

Measure	With-in Subjects Trial n=3 Participants Subjects were randomized to 0.3 mg/kg Immediate Release Methylphenidate va placebo over 3-weeks duration
Length of Wakings	3.28 minutes Interval 1.52 to 5.88

SECONDARY outcome

Timeframe: 3 weeks

We calculated Night to night variability by the difference between the mean sleep onset latency during the weekend days and the mean sleep onset latency during the weekdays.

Outcome measures

Measure	With-in Subjects Trial n=3 Participants Subjects were randomized to 0.3 mg/kg Immediate Release Methylphenidate va placebo over 3-weeks duration
Night to Night Variability (Weekends & Weekdays) - in Sleep Onset Latency Measured by Actigraphy	35.96 minutes Interval 0.0 to 95.0

SECONDARY outcome

Timeframe: 3 weeks

Higher scores mean severe symptoms This scales has 10 items, which are reported as Not at all (0), just a little (1), pretty much (2) and very much (3) Total score is calculated by summiting all items. Total Score Ranges (0-30)

Outcome measures

Measure	With-in Subjects Trial n=3 Participants Subjects were randomized to 0.3 mg/kg Immediate Release Methylphenidate va placebo over 3-weeks duration
Parent Rated 10-item IOWA	13.3 score on a scale Interval 9.0 to 17.0

SECONDARY outcome

Timeframe: 3 weeks

Higher scores mean a worse symptoms This scales has 7 items, which are reported as Not true (0), somewhat true (1) certainly true (2) Total score is calculated by summiting all items. Total Score Ranges (0-14)

Outcome measures

Measure	With-in Subjects Trial n=3 Participants Subjects were randomized to 0.3 mg/kg Immediate Release Methylphenidate va placebo over 3-weeks duration
Affective Reactivity Index (ARI)	5 score on a scale Interval 1.0 to 10.0

Adverse Events

With-in Subjects Trial

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

Raman Baweja, MD, MS

Penn State Health Milton S Hershey Medical Center

Phone: 7175318134

Email: rbaweja@pennstatehealth.psu.edu

Results disclosure agreements

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