EpilepsyPhase 3NCT01161108
Trial of Melatonin to Improve Sleep in Children With Epilepsy and Neurodevelopmental Disabilities
A Phase 3 study testing Fast Release Melatonin (FR MLT) and Timed Release Melatonin (TR MLT) in people with Epilepsy and Insomnia, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
The purpose of the study is to evaluate the safety and efficacy of oral melatonin in improving sleep continuity in children with epilepsy and neurodevelopmental delay who have chronic insomnia by comparing Fast Release Melatonin (FR MLT) to placebo and Timed Release Melatonin (TR MLT) with placebo in a randomized… Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Epilepsy, Insomnia, Developmental Disability
- What is being tested?
- Fast Release Melatonin (FR MLT) and Timed Release Melatonin (TR MLT)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2010to Jun 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 5-17 years
- Children with epilepsy with at least 2 partial or generalized seizures per month over the last 3 months prior to starting the trial
- Children with neurodevelopmental disability, i.e. significant delay in development requiring special educational setting or educational assistant
- Anti-epileptic drugs (AED's) expected to remain unchanged for duration of trial (14 weeks)
- Not currently using melatonin or any other medication for sleep Subjects will be eligible if they have previous use of melatonin as long as there is a washout period of at least 1 week. Similarly, children taking natural health products for sleep will be included as long as there is a 30 day washout period prior to study enrollment.
- Chronic insomnia - reported by parent(s) to include one of the following: sleep onset latency of greater than one hour, duration of sleep less than 8.5 hours per night with either/or both these problems occurring at least 3 nights per week and that have occurred 3 months prior to trial, or night wakings of more than 2 per night for same time period
Who cannot join
- Planned epilepsy surgery or change in AED's during treatment trial
- Sleep disturbances that are treatable such as obstructive sleep apnea
- Allergy or severe adverse effects to melatonin
- Allergy or severe adverse effects to any of the ingredients of the study product or placebo (e.g. lactose)
- Lactose intolerance
- Pregnant
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- Breastfeeding
- Known liver disease
- Ketogenic diet
- Other drugs being used for sedation
- Immunosuppressive drugs
- Known blood clotting abnormalities or who are on anticoagulant therapy (e.g. warfarin, blood thinners)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial Pilot Project to Evaluate the Efficacy of Melatonin in Children With Insomnia, Intractable Epilepsy and Neurodevelopmental Disabilities
The purpose of the study is to evaluate the safety and efficacy of oral melatonin in improving sleep continuity in children with epilepsy and neurodevelopmental delay who have chronic insomnia by comparing Fast Release Melatonin (FR MLT) to placebo and Timed Release Melatonin (TR MLT) with placebo in a randomized cross-over design trial.
Read the detailed description
Sleep disturbance in children is a universal concern. The prevalence of sleep disorders may be as high as 80% in children with neurodevelopmental disabilities. The majority of the parental complaints are with difficulty getting children to settle to sleep at night and stay asleep (insomnia).
Two recent studies comparing children with epilepsy to matched controls or to sibling controls both concluded that children with epilepsy have more daytime sleepiness that may be due to underlying sleep disorders, and significantly greater sleep problems than their non-epileptic peers.
Endogenous melatonin is thought to synchronize the sleep-wake pattern with the light-dark cycle of the normal day. Exogenous melatonin has been found to be effective in reducing sleep onset latency, increasing sleep duration, and increasing sleep efficiency in a meta-analysis of subjects with sleep disorders. The melatonin in fast release preparations is released quickly and has a short half-life of less than 1 hour. It is most helpful in decreasing sleep onset latency (the time to fall asleep). The melatonin in timed release tablets is released in a slower more sustained way and, in a small study in children with severe neurodevelopmental disabilities, was more useful for sleep maintenance.
Fast release melatonin has been shown to be effective in a study of children with multiple disabilities and in one trial in children with epilepsy. Further rigorous evaluation of melatonin is needed as the validity of these studies is limited by their lack of blinding, small sample sizes, and subjective methods of sleep-wake outcome evaluations.
- Conditions
- Epilepsy, Insomnia, Developmental Disability
- Being tested
- Fast Release Melatonin (FR MLT), Fast Release Placebo, Timed Release Melatonin (TR MLT), Timed Release Placebo
- Keywords
- Pediatrics, Epilepsy, Insomnia, Melatonin
- Medical subject headings
- Epilepsy, Sleep Initiation and Maintenance Disorders, Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fast Release Melatonin (FR MLT)Drug
Also called Sleep Tight TM by Nature's Harmony® Melatonin
3mg capsules of melatonin will be used. The dose of FR MLT will be 3 mg for children less than or equal to 20 kg, and 6 mg for children greater than 20 kg. The study medication will be given one hour before bedtime, once daily.
Fast Release PlaceboDrug
A matching FR MLT placebo will be compounded by the SickKids research pharmacy.
The dose of Fast Release Placebo will be 3 mg for children less than or equal to 20 kg, and 6 mg for children greater than 20 kg. The study medication will be given one hour before bedtime, once daily.
Timed Release Melatonin (TR MLT)Drug
Also called Melatonin Timed Release by General Nutrition Canada
3 mg capsules will be used.
The dose of TR MLT will be will be 3 mg for children less than or equal to 20 kg, and 6 mg for children greater than 20 kg. The study medication will be given one hour before bedtime, once daily.
Timed Release PlaceboDrug
A matching TR MLT placebo will be compounded by the SickKids research pharmacy.
The dose of Timed Release Placebo will be will be 3 mg for children less than or equal to 20 kg, and 6 mg for children greater than 20 kg. The study medication will be given one hour before bedtime, once daily.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Fast Release Melatonin | Active comparator | Subjects will be randomized to one of the two treatment arms and to the order of study medication v.s. placebo.
The subject will undergo the assigned treatment for 7 weeks (3 weeks of study drug, a one week wash-out and 3 weeks of placebo, or vice versa). Receives: Drug: Fast Release Melatonin (FR MLT); Drug: Fast Release Placebo |
| Group B: Timed Release Melatonin | Active comparator | Subjects will be randomized to one of the two treatment arms and to the order of study medication v.s. placebo.
The subject will undergo the assigned treatment for 7 weeks (3 weeks of study drug, a one week wash-out and 3 weeks of placebo, or vice versa). Receives: Drug: Timed Release Melatonin (TR MLT); Drug: Timed Release Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in duration of nocturnal sleep time
We will measure the sleep time between 7 pm and 9 am.
The measures will be analyzed to determine the change from baseline and change between active treatment and placebo.
Measured: Baseline, Weeks 9 and 13
Secondary outcomes (2)
Sleep onset latency
We will measure the interval of time between lights out and the onset of sleep.
The measures will be analyzed to determine the change from baseline and change between active treatment and placebo.
Measured: Baseline, Weeks 9 and 13
Sleep efficiency
We will measure the time sleeping/time in bed between lights out at night and lights on in the morning.
The measures will be analyzed to determine the change from baseline and change between active treatment and placebo
Measured: Baseline, Weeks 9 and 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionMay 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shelly Weiss, The Hospital for Sick Children
- Investigators
- Shelly Weiss, MD, Principal investigator, The Hospital for Sick Children, Toronto Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01161108
- Sponsor's protocol ID
- 1000010842
- Status last verified
- Dec 2014
- First submitted
- 9 Jul 2010
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Pilot Project to Evaluate the Efficacy of Melatonin in Children With Insomnia, Intractable Epilepsy and Neurodevelopmental Disabilities
- ClinicalTrials.gov ID
- NCT01161108
- Acronym / sponsor ID
- 1000010842
- Conditions
- Epilepsy, Insomnia, Developmental Disability
- Keywords
- Pediatrics, Epilepsy, Insomnia, Melatonin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- May 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 13 Jul 2010 (estimated)
- Results
- Not posted in the source record
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 the study is to evaluate the safety and efficacy of oral melatonin in improving sleep continuity in children with epilepsy and neurodevelopmental delay who have chronic insomnia by comparing Fast Release Melatonin (FR MLT) to placebo and Timed Release Melatonin (TR MLT) with placebo in a randomized cross-over design trial.
Detailed description
Sleep disturbance in children is a universal concern. The prevalence of sleep disorders may be as high as 80% in children with neurodevelopmental disabilities. The majority of the parental complaints are with difficulty getting children to settle to sleep at night and stay asleep (insomnia).
Two recent studies comparing children with epilepsy to matched controls or to sibling controls both concluded that children with epilepsy have more daytime sleepiness that may be due to underlying sleep disorders, and significantly greater sleep problems than their non-epileptic peers.
Endogenous melatonin is thought to synchronize the sleep-wake pattern with the light-dark cycle of the normal day. Exogenous melatonin has been found to be effective in reducing sleep onset latency, increasing sleep duration, and increasing sleep efficiency in a meta-analysis of subjects with sleep disorders. The melatonin in fast release preparations is released quickly and has a short half-life of less than 1 hour. It is most helpful in decreasing sleep onset latency (the time to fall asleep). The melatonin in timed release tablets is released in a slower more sustained way and, in a small study in children with severe neurodevelopmental disabilities, was more useful for sleep maintenance.
Fast release melatonin has been shown to be effective in a study of children with multiple disabilities and in one trial in children with epilepsy. Further rigorous evaluation of melatonin is needed as the validity of these studies is limited by their lack of blinding, small sample sizes, and subjective methods of sleep-wake outcome evaluations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Fast Release Melatonin | Active comparator | Drug: Fast Release Melatonin (FR MLT), Drug: Fast Release PlaceboSubjects will be randomized to one of the two treatment arms and to the order of study medication v.s. placebo. The subject will undergo the assigned treatment for 7 weeks (3 weeks of study drug, a one week wash-out and 3 weeks of placebo, or vice versa). |
| Group B: Timed Release Melatonin | Active comparator | Drug: Timed Release Melatonin (TR MLT), Drug: Timed Release PlaceboSubjects will be randomized to one of the two treatment arms and to the order of study medication v.s. placebo. The subject will undergo the assigned treatment for 7 weeks (3 weeks of study drug, a one week wash-out and 3 weeks of placebo, or vice versa). |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children aged 5-17 years
- Children with epilepsy with at least 2 partial or generalized seizures per month over the last 3 months prior to starting the trial
- Children with neurodevelopmental disability, i.e. significant delay in development requiring special educational setting or educational assistant
- Anti-epileptic drugs (AED's) expected to remain unchanged for duration of trial (14 weeks)
- Not currently using melatonin or any other medication for sleep Subjects will be eligible if they have previous use of melatonin as long as there is a washout period of at least 1 week. Similarly, children taking natural health products for sleep will be included as long as there is a 30 day washout period prior to study enrollment.
Key exclusion criteria (12 listed)
- Planned epilepsy surgery or change in AED's during treatment trial
- Sleep disturbances that are treatable such as obstructive sleep apnea
- Allergy or severe adverse effects to melatonin
- Allergy or severe adverse effects to any of the ingredients of the study product or placebo (e.g. lactose)
- Lactose intolerance
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 |
|---|---|---|
| Fast Release Melatonin (FR MLT)Also: Sleep Tight TM by Nature's Harmony® Melatonin3mg capsules of melatonin will be used. The dose of FR MLT will be 3 mg for children less than or equal to 20 kg, and 6 mg for children greater than 20 kg. The study medication will be given one hour before bedtime, once daily. | Drug | Group A: Fast Release Melatonin |
| Fast Release PlaceboA matching FR MLT placebo will be compounded by the SickKids research pharmacy. The dose of Fast Release Placebo will be 3 mg for children less than or equal to 20 kg, and 6 mg for children greater than 20 kg. The study medication will be given one hour before bedtime, once daily. | Drug | Group A: Fast Release Melatonin |
| Timed Release Melatonin (TR MLT)Also: Melatonin Timed Release by General Nutrition Canada3 mg capsules will be used. The dose of TR MLT will be will be 3 mg for children less than or equal to 20 kg, and 6 mg for children greater than 20 kg. The study medication will be given one hour before bedtime, once daily. | Drug | Group B: Timed Release Melatonin |
| Timed Release PlaceboA matching TR MLT placebo will be compounded by the SickKids research pharmacy. The dose of Timed Release Placebo will be will be 3 mg for children less than or equal to 20 kg, and 6 mg for children greater than 20 kg. The study medication will be given one hour before bedtime, once daily. | Drug | Group B: Timed Release Melatonin |
Primary outcome
Change in duration of nocturnal sleep time
Time frame: Baseline, Weeks 9 and 13
We will measure the sleep time between 7 pm and 9 am. The measures will be analyzed to determine the change from baseline and change between active treatment and placebo.
2 secondary outcomes
Sleep onset latency
Time frame: Baseline, Weeks 9 and 13
Sleep efficiency
Time frame: Baseline, Weeks 9 and 13
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2014.
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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.
Shelly Weiss, MD principal investigator
The Hospital for Sick Children, Toronto Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fast Release Melatonin (FR MLT) and Timed Release Melatonin (TR MLT) in people with Epilepsy and Insomnia, run by The Hospital for Sick Children at 1 site in Canada.
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 6 inclusion and 12 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: finished, as of the sponsor's last update on 2 Dec 2014. 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 Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in duration of nocturnal sleep time (time frame: Baseline, Weeks 9 and 13). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Dec 2014.