Trial · NCT01906866

Efficacy and Safety of Circadin® in the Treatment of Sleep Disturbances in Children With Neurodevelopment Disabilities

NCT01906866, Phase 3, Completed, Neurim Pharmaceuticals Ltd.; results first posted 2018-10-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety of Circadin® in the Treatment of Sleep Disturbances in Children With Neurodevelopment Disabilities. Trials, record NCT01906866. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01906866

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy and Safety of Circadin® in the Treatment of Sleep Disturbances in Children With Neurodevelopment Disabilities
NCT number: NCT01906866
Status: Completed
Phases: Phase 3
Enrollment: 125 participants, actual
Lead sponsor: Neurim Pharmaceuticals Ltd.
Conditions: Sleep Disorders
Interventions: Circadin 2/5/10 mg, Placebo
First posted: 2013-07-24
Last updated: 2024-04-23
Results first posted: 2018-10-30

Source ClinicalTrials.gov

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Total Sleep Time (TST)	13 weeks	The treatment effect of Circadin® 2/5 mg minitabs was compared to that of a placebo on total sleep time, as assessed by the Sleep and Nap Diary questionnaire, following 13 weeks of double-blind treatment
Secondary	Sleep Latency (Mins)	13 weeks	Sleep Latency (minutes) derived from Sleep and Nap Diary following 13 weeks of double-blind treatment with Circadin 2/5 mg minitabs versus placebo. The lower the value for sleep latency, the better the outcome.
Secondary	Duration of Wake After Sleep	13 weeks	Duration of Wake after Sleep onset period derived from Sleep and Nap Diary following 13 weeks of double-blind treatment with Circadin 2/5 mg minitabs versus placebo. The shorter the value, the better the outcome.
Secondary	Number of Awakenings Per Night	13 weeks	Number of awakenings per night will be assessed by a Sleep and Nap Diary and summarized after 13 weeks of double-blind treatment for each treatment group using descriptive statistics. The smaller the number, the better the outcome.
Secondary	Longest Sleep Period	13 weeks	The longest sleep period following 13 weeks of double-blind treatment with Circadin 2/5 mg and placebo was evaluated by a Sleep and Nap Diary questionnaire. The longer the sleep period, the better the outcome.
Secondary	Social Functioning - Children Global Assessment Scale (CGAS)	13 weeks	The Children's Global Assessment Scale (CGAS) Questionnaire measures social functioning at home, in school, and in community settings. The scores range from 1, which is the very worst, to 100, which is the very best.
Secondary	Behavior at Home and in School - Strengths and Difficulties Questionnaire (SDQ)	13 weeks	The Strengths and Difficulties Questionnaire (SDQ) is a brief, 25-item, measure of behavioral and emotional difficulties that can be used to assess behavior at home and in school in children. The SDQ consists of 25 items which are divided into 5 subscales: 1) emotional symptoms (5 items); 2) conduct problems (5 items); 3) hyperactivity/inattention (5 items); 4) peer relationship problems (5 items); and 5) prosocial behavior (5 items). Subscales 1 to 4 are summed to generate a Total Difficulties Score (that ranges from 0 to 40). Each item on the SDQ is scored on a 3-point ordinal scale with 0 = not true, 1 = somewhat true, and 2 = certainly true, with higher scores indicating larger problems.
Secondary	Number of Dropouts	13 weeks	Number of dropouts during the 13 weeks of double-blind treatment in the Circadin 2/5 mg and placebo arms.
Secondary	Assessment of Sleep Parameters by Actigraphy	13 weeks	Actigraphy is a validated method of objectively measuring sleep parameters and average motor activity over days to weeks using a noninvasive device. Despite major efforts to ensure adherence, actigraphy monitoring was challenging in this population, and a majority of patients (75% in the Circadin and 77% in the placebo group) refused to wear the device and/or took it off sometime during the night. Only 12 patients in the Circadin and 13 in the placebo group had data for both baseline and 13 weeks of treatment, and even in those it was not possible to ascertain that they wore the device throughout the night.
Secondary	Safety and Tolerability - Treatment Emergent Signs and Symptoms (TESS) Summary.	13 weeks, 26 weeks, 52 weeks.	Treatment Emergent Signs and Symptoms (TESS). Signs and symptoms not seen at baseline (i.e. before starting the treatment) and/or worsened even if present at baseline.

1 to 10 of 14Source ClinicalTrials.gov

See all 14 registered outcomes

Outcomes14

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Total Sleep Time (TST)	13 weeks	All patients in the Safety Analysis Set who satisfied all major entry criteria (I.Criteria 1-5) and who had a valid mean TST result recorded for baseline and at least one post-baseline period assessment during the double-blind phase.~Patients were classified according to randomized treatment. This analysis set was used for all efficacy analyses.	minutes	MEAN
SECONDARY	Sleep Latency (Mins)	13 weeks	All patients in the Safety Analysis Set who satisfied all major entry criteria (I.Criteria 1-5) and who had a valid mean TST result recorded for baseline and at least one post-baseline period assessment during the double-blind phase. Patients were classified according to randomized treatment. This analysis set was used for all efficacy analyses	minutes	MEAN
SECONDARY	Duration of Wake After Sleep	13 weeks		minutes	MEAN
SECONDARY	Number of Awakenings Per Night	13 weeks		Number of awakenings per night	MEAN
SECONDARY	Longest Sleep Period	13 weeks	FAS (Full analysis set)	minutes	MEAN
SECONDARY	Social Functioning - Children Global Assessment Scale (CGAS)	13 weeks	FAS set	score on a scale	MEAN
SECONDARY	Behavior at Home and in School - Strengths and Difficulties Questionnaire (SDQ)	13 weeks		score on a scale	MEAN
SECONDARY	Number of Dropouts	13 weeks	Safety set	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Assessment of Sleep Parameters by Actigraphy	13 weeks	Despite major efforts to ensure adherence, actigraphy monitoring was challenging in this population, and a majority of patients (75% in the Circadin and 77% in the placebo group) refused to wear the device during one or both periods and/or took it off some time during the night. Only 12 patients in the Circadin and 13 in the placebo group had data for both baseline and 13 weeks of treatment, and even in those it was not possible to ascertain that they wore the device throughout the night.	minutes	MEAN
SECONDARY	Safety and Tolerability - Treatment Emergent Signs and Symptoms (TESS) Summary.	13 weeks, 26 weeks, 52 weeks.	Safety Set	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 14Source ClinicalTrials.gov

See all 14 outcomes

Results by group516

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Total Sleep Time (TST)	Circadin 2/5/10 mg		51.03	95% Confidence Interval 30.3 to 71.76	minutes
Total Sleep Time (TST)	Placebo		18.71	95% Confidence Interval -2.73 to 40.15	minutes
Sleep Latency (Mins)	Circadin 2/5/10 mg	Baseline	95.16	Standard Error 59.253	minutes
Sleep Latency (Mins)	Placebo	Baseline	98.76	Standard Error 73.899	minutes
Sleep Latency (Mins)	Circadin 2/5/10 mg	13 weeks	60.74	Standard Error 42.111	minutes
Sleep Latency (Mins)	Placebo	13 weeks	76.88	Standard Error 82.589	minutes
Duration of Wake After Sleep	Circadin 2/5/10 mg	Baseline	64.4	Standard Deviation 24.421	minutes
Duration of Wake After Sleep	Placebo	Baseline	64.89	Standard Deviation 32.525	minutes
Duration of Wake After Sleep	Circadin 2/5/10 mg	13 weeks	68.75	Standard Deviation 32.199	minutes
Duration of Wake After Sleep	Placebo	13 weeks	70.89	Standard Deviation 51.590	minutes

1 to 10 of 516Source ClinicalTrials.gov

See all 516 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Circadin 2/5/10 mg	60
Overall Study	STARTED	Placebo	65
Overall Study	COMPLETED	Circadin 2/5/10 mg	51
Overall Study	COMPLETED	Placebo	44
Overall Study	NOT COMPLETED	Circadin 2/5/10 mg	9
Overall Study	NOT COMPLETED	Placebo	21

Source ClinicalTrials.gov

Adverse events30

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Non-serious adverse events	Respiratory, thoracic and mediastinal disorders	Circadin 2/5/10 mg Double Blind	16	60	16
other	Non-serious adverse events	Respiratory, thoracic and mediastinal disorders	Placebo	10	65	10
other	Non-serious adverse events	Respiratory, thoracic and mediastinal disorders	Circadin 2/5/10 mg Open Label	37	95	50
other	Non-serious adverse events	Nervous system disorders	Circadin 2/5/10 mg Double Blind	25	60	26
other	Non-serious adverse events	Nervous system disorders	Placebo	12	65	12
other	Non-serious adverse events	Nervous system disorders	Circadin 2/5/10 mg Open Label	42	95	51
other	Non-serious adverse events	General disorders	Circadin 2/5/10 mg Double Blind	23	60	28
other	Non-serious adverse events	General disorders	Placebo	19	65	28
other	Non-serious adverse events	General disorders	Circadin 2/5/10 mg Open Label	39	95	49
other	Non-serious adverse events	Gastrointestinal disorders	Circadin 2/5/10 mg Double Blind	15	60	15

1 to 10 of 30Source ClinicalTrials.gov

See all 30 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Circadin 2/5/10 mg Double Blind	0	60
Total, all-cause mortality	Placebo	0	65
Total, all-cause mortality	Circadin 2/5/10 mg Open Label	0	95
Total, other adverse events	Circadin 2/5/10 mg Double Blind	51	60
Total, other adverse events	Placebo	50	65
Total, other adverse events	Circadin 2/5/10 mg Open Label	80	95
Total, serious adverse events	Circadin 2/5/10 mg Double Blind	0	60
Total, serious adverse events	Placebo	1	65
Total, serious adverse events	Circadin 2/5/10 mg Open Label	6	95

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
29096777	DERIVED	PubMed
31982581	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Circadin 2/5/10 mg vs Placebo: Number of Dropouts

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

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