Sleep DisorderPhase 4NCT01033565
Melatonin CR for the Treatment of Impaired Sleep Maintenance in 4-8 Year Old Children With Autism Spectrum Disorders
A Phase 4 study testing Natrol in people with Sleep Disorder, run by University of Nebraska at 1 site in United States.
Trial summary
The purpose of this research is to see the effects (good and bad) of Melatonin CR on sleep in 4-8 year old children with autism spectrum disorders and sleep problems. Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Sleep Disorder
- What is being tested?
- Natrol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2010to 1 Oct 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female children,
- ages 4-8 years,
- diagnosed with an ASD, including
- Pervasive Developmental Disorder NOS (PDD, NOS),
- Asperger's Syndrome, or
- Autistic Disorder, and followed in the Munroe Meyer Developmental Pediatrics Clinic. Documented impaired sleep maintenance (ISM) based on parent-report and 7 day somnolog (sleep diary).
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- Clinician rating of 4 (moderately ill) or worse on CGI-S. Rating is based on the clinician's experience with evaluating and treating this patient population.
- Previous discussion during a clinic appointment about sleep difficulties, including review of sleep hygiene and basic behavioral interventions/strategies.
- Current problems of overnight awakenings recorded on the Children's Sleep Habits Questionnaire (CSHQ) despite behavioral intervention.
- Stable psychotropic medication treatment for the past 4 weeks.
Who cannot join
- Treatment with Melatonin or Melatonin CR during the past month or previous failed treatment with Melatonin CR.
- Presence of a previously unevaluated medical condition which may be the etiology of the nighttime awakenings. There is no contraindication for use of Melatonin CR in patients with obstructive sleep apnea.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center-Munroe Meyer Institute
Omaha, Nebraska, 68198-5380
About this study
Official title: Controlled-Release Melatonin (Melatonin CR)for the Treatment of Impaired Sleep Maintenance (ISM) in 4-8 Year Old Children With Autism Spectrum Disorders (ASD).
The purpose of this research is to see the effects (good and bad) of Melatonin CR on sleep in 4-8 year old children with autism spectrum disorders and sleep problems.
Read the detailed description
The title of this acute, open-label pilot study is "Controlled Release Melatonin (Melatonin CR) for the treatment of impaired sleep maintenance (ISM) in 4-8 year old children with autism spectrum disorders (ASD)." Maintenance of sleep is a significant challenge in the treatment of children with neurodevelopmental disabilities including ASDs. Night awakening or early morning waking can have detrimental effects on these children's daytime behavior and the functioning of their household. Sleep problems in the ASD population are generally managed first with behavioral interventions and, when these are not successful, pharmacologic therapy. Most medications effect sleep onset and not sleep maintenance. This study investigates the effectiveness of Melatonin CR for managing ISM in 4-8 year old children with ASD. Twenty patients will be recruited from the Developmental/Behavioral Pediatrics Clinic at the Munroe Meyer Institute at the University of Nebraska Medical Center. Inclusion criteria are male and female children ages 4-8 years with a diagnosis of an ASD, including Pervasive Developmental Disorder NOS (PDD, NOS), Asperger's Syndrome, or Autistic Disorder, parent/guardian consent for participation, stable psychotropic medication treatment for at least 4 weeks, and a documented history of ISM based on parent-report, somnolog and Child Sleep Habits Questionnaire (CSHQ), and a clinician rating of ≥4 (moderately ill) on the Clinical Global Impression-Severity (CGI-S) Scale. Patients will be excluded if they have been treated with Melatonin or Melatonin CR in the past month, failed treatment with Melatonin CR, or if they have a previously un-evaluated medical condition which may be causing the ISM. Following the completion of a somnolog and standardized questionnaires, the patients will be treated for 10-14 days with melatonin CR. Somnologs will be completed during treatment, and standardized parent questionnaires, CGI-S, and adverse event collection will be repeated at the end of Melatonin CR therapy. Response will be defined as a Clinical Global Impression-Improvement (CGI-I) score of 1 or 2 (much or very much improved). These will be compared to baseline ratings. Following the completion of the study protocol, all patients will continue to be followed in the Developmental Pediatrics clinic. Data from this acute pilot trial can be used to evaluate the appropriateness of a larger study to determine optimal therapy for patients with ASD and ISM.
- Conditions
- Sleep Disorder
- Being tested
- Natrol
- Keywords
- Impaired sleep maintenance, Autism Spectrum Disorders, Pediatric
- Medical subject headings
- Sleep Wake Disorders, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NatrolDrug
Also called Sustained release melatonin
5mg of sustained released melatonin. One tablet given 30 minutes prior to bedtime.
| Study group | Role | What they receive |
|---|---|---|
| Natrol | Experimental | Subjects receive Natrol (sustained release melatonin) 5mg tablet 30 minutes prior to bedtime for 10 to 14 days Receives: Drug: Natrol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Global Impression-Improvement
Assigns numerical score indicating level of improvement compared to baseline. Scale is rated from 1-7: 1= very much improved; 2= much improved; 3= minimally improved; 4= no change; 5= minimally worse; 6= much worse; 7= very much worse.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2009 (estimated)
- Study start4 Mar 2010
- Primary completion1 Oct 2010
- Study completion1 Oct 2010
Why it stopped: Unsuccessful in recruiting appropriate subjects.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep DisorderStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Howard Needelman, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01033565
- Sponsor's protocol ID
- 0401-09-FB
- Status last verified
- Aug 2023
- First submitted
- 14 Dec 2009
- Last updated
- 8 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Braam W, Smits MG, Didden R, Korzilius H, Van Geijlswijk IM, Curfs LM. Exogenous melatonin for sleep problems in individuals with intellectual disability: a meta-analysis. Dev Med Child Neurol. 2009 May;51(5):340-9. doi: 10.1111/j.1469-8749.2008.03244.x.
PubMed 19379289
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled-Release Melatonin (Melatonin CR)for the Treatment of Impaired Sleep Maintenance (ISM) in 4-8 Year Old Children With Autism Spectrum Disorders (ASD).
- ClinicalTrials.gov ID
- NCT01033565
- Acronym / sponsor ID
- 0401-09-FB
- Conditions
- Sleep Disorder
- Keywords
- Impaired sleep maintenance, Autism Spectrum Disorders, Pediatric
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unsuccessful in recruiting appropriate subjects.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 4 Mar 2010 (actual)
- Primary completion
- 1 Oct 2010 (actual)
- Study completion
- 1 Oct 2010 (actual)
- First posted
- 16 Dec 2009 (estimated)
- Results
- Posted 9 Sep 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to see the effects (good and bad) of Melatonin CR on sleep in 4-8 year old children with autism spectrum disorders and sleep problems.
Detailed description
The title of this acute, open-label pilot study is "Controlled Release Melatonin (Melatonin CR) for the treatment of impaired sleep maintenance (ISM) in 4-8 year old children with autism spectrum disorders (ASD)." Maintenance of sleep is a significant challenge in the treatment of children with neurodevelopmental disabilities including ASDs. Night awakening or early morning waking can have detrimental effects on these children's daytime behavior and the functioning of their household. Sleep problems in the ASD population are generally managed first with behavioral interventions and, when these are not successful, pharmacologic therapy. Most medications effect sleep onset and not sleep maintenance. This study investigates the effectiveness of Melatonin CR for managing ISM in 4-8 year old children with ASD. Twenty patients will be recruited from the Developmental/Behavioral Pediatrics Clinic at the Munroe Meyer Institute at the University of Nebraska Medical Center. Inclusion criteria are male and female children ages 4-8 years with a diagnosis of an ASD, including Pervasive Developmental Disorder NOS (PDD, NOS), Asperger's Syndrome, or Autistic Disorder, parent/guardian consent for participation, stable psychotropic medication treatment for at least 4 weeks, and a documented history of ISM based on parent-report, somnolog and Child Sleep Habits Questionnaire (CSHQ), and a clinician rating of ≥4 (moderately ill) on the Clinical Global Impression-Severity (CGI-S) Scale. Patients will be excluded if they have been treated with Melatonin or Melatonin CR in the past month, failed treatment with Melatonin CR, or if they have a previously un-evaluated medical condition which may be causing the ISM. Following the completion of a somnolog and standardized questionnaires, the patients will be treated for 10-14 days with melatonin CR. Somnologs will be completed during treatment, and standardized parent questionnaires, CGI-S, and adverse event collection will be repeated at the end of Melatonin CR therapy. Response will be defined as a Clinical Global Impression-Improvement (CGI-I) score of 1 or 2 (much or very much improved). These will be compared to baseline ratings. Following the completion of the study protocol, all patients will continue to be followed in the Developmental Pediatrics clinic. Data from this acute pilot trial can be used to evaluate the appropriateness of a larger study to determine optimal therapy for patients with ASD and ISM.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Natrol | Experimental | Drug: NatrolSubjects receive Natrol (sustained release melatonin) 5mg tablet 30 minutes prior to bedtime for 10 to 14 days |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Male or female children,
- ages 4-8 years,
- diagnosed with an ASD, including
- Pervasive Developmental Disorder NOS (PDD, NOS),
- Asperger's Syndrome, or
Key exclusion criteria (2 listed)
- Treatment with Melatonin or Melatonin CR during the past month or previous failed treatment with Melatonin CR.
- Presence of a previously unevaluated medical condition which may be the etiology of the nighttime awakenings. There is no contraindication for use of Melatonin CR in patients with obstructive sleep apnea.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NatrolAlso: Sustained release melatonin5mg of sustained released melatonin. One tablet given 30 minutes prior to bedtime. | Drug | Natrol |
Primary outcome
Clinical Global Impression-Improvement
Time frame: 2 weeks
Assigns numerical score indicating level of improvement compared to baseline. Scale is rated from 1-7: 1= very much improved; 2= much improved; 3= minimally improved; 4= no change; 5= minimally worse; 6= much worse; 7= very much worse.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19379289Braam W, Smits MG, Didden R, Korzilius H, Van Geijlswijk IM, Curfs LM. Exogenous melatonin for sleep problems in individuals with intellectual disability: a meta-analysis. Dev Med Child Neurol. 2009 May;51(5):340-9. doi: 10.1111/j.1469-8749.2008.03244.x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Howard Needelman, MD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Natrol in people with Sleep Disorder, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Global Impression-Improvement (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01033565, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023.