Sleep DisordersPhase 3NCT01906866
Efficacy and Safety of Circadin® in the Treatment of Sleep Disturbances in Children With Neurodevelopment Disabilities
A Phase 3 study testing Circadin 2/5/10 mg in people with Sleep Disorders, run by Neurim Pharmaceuticals Ltd. at 28 sites in 5 countries.
Trial summary
The purpose of this study is to establish the efficacy and safety of Circadin in children with neurodevelopmental disorders and to determine the dose, this randomized, placebo-controlled study is planned to evaluate the efficacy of a double-blind, 13 week treatment period with Circadin 2/5mg in improving maintenance… Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Sleep Disorders
- What is being tested?
- Circadin 2/5/10 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- 28 sitesin 5 countries
- Study dates
- Oct 2013to 27 Mar 2018
- Phase
- Phase 3
- 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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- To be eligible for study entry, all patients must satisfy all of the following criteria at screening:
- Must be children 2 to 17.5 years of age at Visit 2 who comply with taking the study drug
- Must have written informed consent provided by a legal guardian and assent (if needed)
- Must have a documented history of ASD according to or consistent with the ICD-10 (International Classification of Diseases) or DSM-5/4 (Diagnostic and Statistical Manual of Mental Disorders) criteria, or neurodevelopmental disabilities caused by neurogenetic diseases (i.e., Smith-Magenis syndrome, Angelman syndrome, Bourneville's disease [tuberous sclerosis]) as confirmed by case note review showing that diagnosis was reached through assessment by a community pediatrician or pediatric neurologist or other health care professionals experienced in the diagnosis who took into account early developmental history and school records.
- Must have current sleep problems including: a minimum of 3 months of impaired sleep defined as ≤6 hours of continuous sleep AND/OR ≥0.5 hour sleep latency from light off in 3 out of 5 nights based on parent reports and patient medical history. (The maintenance and latency problems do not necessarily have to be in the same 3 nights of the week.)
- May be on a stable dose of non-excluded medication for 3 months, including anti- epileptics, anti-depressants (selective serotonin reuptake inhibitors [SSRIs]), stimulants, all mood changing drugs and β-blockers. (Only morning administration of β-blockers is allowed since β-blockers at night have the potential to reduce endogenous melatonin levels and might cause disturbed sleep)
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- The sleep disturbance is not due to the direct physiological effects of any concomitant medications such as SSRIs, stimulants, etc.
- After completing 4 weeks of sleep hygiene training (for those who need it) and 2 weeks of placebo run-in, patients will be eligible to continue the study if they comply with the following:
- Continue to fulfill sleep problem criteria (see Inclusion Criterion 4) based on the completed Sleep and Nap Diary entered into the electronic case report form
- Parents demonstrate compliance in Sleep and Nap Diary completion (5 out of 7 nights). Compliance means that in at least 5 out of 7 nights per week (total of 2 weeks before each scheduled visit) the parents complete the diary pages with all mandatory questions
- Continue to fulfil all other eligibility criteria
Who cannot join
- Children who meet any of the following criteria will be excluded from participating in the study:
- Have had treatment with any form of melatonin within 2 weeks prior to Visit 1
- Have a known allergy to melatonin or lactose
- Have a known moderate to severe sleep apnea
- Have an untreated medical/ineffectively treated/psychological condition that may be the etiology of sleep disturbances
- Did not respond to previous Circadin® therapy based on past medical history records in the last 2 years
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- Are taking or have been taking prohibited medication within 2 weeks prior to Visit 1 (Section 7.1)
- Are females of child-bearing potential that are not using contraceptives and/or breastfeeding and that are sexually active (Abstinence is an acceptable method of contraception.)
- Pregnant females
- Are currently participating in a clinical trial or have participated in a clinical trial involving medicinal product within the last 3 months prior to the study [this does not include patients who participated in the Phase I Pharmacokinetics (PK) study who can be already included in the study]
- Children with known renal or hepatic insufficiency
Trial locations and contacts
28 sites in 5 countries.
28 sites in 5 countries
United States18 sites
Kennedy Krieger Institute
Baltimore, Maryland, 21205
Pacific institute of medical science
Bothell, Washington, 98011
Ericksen Research & Development
Clinton, Utah, 32763
Geinsinger Clinic
Danville, Pennsylvania, 17822
INSITE Clinical Research
DeSoto, Texas, 75115
Child Neurology Specialists/ CRCN
Henderson, Nevada, 89052
Red Oak Psychiatry Associates
Houston, Texas, 77090
Crystal BioMedical Research, LLC
Miami Lakes, Florida, 33014
AMR Baber research INC
Naperville, Illinois, 60563
Vanderbilt University
Nashville, Tennessee, 37240
Lake Mary Pediatrics
Orange City, Florida, 32763
The children's hospital of Philadelphia
Philadelphia, Pennsylvania, 19104-4399
Southwest Autism Research and Resource Center (SARRC)
Phoenix, Arizona, 85006
Sleep Therapy & Research Center
San Antonio, Texas, 78229
Road Runner Research, Ltd
San Antonio, Texas, 78258
Attalla Consultants LLC, dba Institue for Behabiovral medicine
Smyrna, Georgia, 30080-6315
Clinical research center of New Jersey, LLC
Voorhees Township, New Jersey, 08043
Mate Lazlo
West Palm Beach, Florida, 33408
United Kingdom4 sites
Birmingham Childrens Hospital NHS FOUNDATION TRUST
Birmingham
Blackpool Victoria Teaching Hospitals NHS Foundation Trust
Blackpool
Guy's & St. Thomas's NHS Foundation Trust of St Thomas's Hospital
London
University Hospital Southampton NHS Foundation Trust
Southampton
Netherlands3 sites
Yulius Mental Health Organization
Dordrecht
Hospital Gelderse Vallei
Ede
University Medical Center Groningen
Groningen
France2 sites
Hospital Raymond Poincare
Garches
Strasbourg University Hospital Depatment of Child Psychiatry & Neurology
Strasbourg
About this study
Official title: A Randomized, Placebo-controlled Study to Investigate the Efficacy and Safety of Circadin® to Alleviate Sleep Disturbances in Children With Neurodevelopmental Disabilities
The purpose of this study is to establish the efficacy and safety of Circadin in children with neurodevelopmental disorders and to determine the dose, this randomized, placebo-controlled study is planned to evaluate the efficacy of a double-blind, 13 week treatment period with Circadin 2/5mg in improving maintenance of sleep, sleep latency and additional parameters in children with neurodevelopmental disabilities. The efficacy and safety of Circadin 2/5 mg will continue to be assessed during an open-label extension period of 13 weeks.
Read the detailed description
This is a randomized placebo-controlled study in children diagnosed with autism spectrum disorders (ASDs) and neurodevelopmental disabilities caused by neurogenetic diseases.
Children who are found to be eligible for the study will follow a 4-week, basic sleep hygiene and behavioral intervention wash-out period, and will continue in a 2-week single-blind (SB) placebo run-in period. Then, they will be randomized in a 1:1 ratio to receive either Circadin® 2 mg or placebo for 3 weeks in a double-blind treatment period.
After 3 weeks of treatment, on the last day of Week 5 ±3 days (Visit 3), sleep variables will be assessed to determine if dose modification (an increase to 5 mg) is required. Children will then continue on 2 or 5 mg of Circadin® or placebo for an additional double-blind period of 10 weeks. This double-blind period will be followed by an open-label period of 13 weeks. At the end of the 13-week open-label period on the last day of Week 28 ±3 days (Visit 5), sleep variables will be assessed to determine if a potential additional dose modification (i.e., an increase either to 5 mg for patients who are still on 2 mg or an increase to 10 mg for patients who are on 5 mg) is necessary (If a dose increase is decided upon, the dose increase should be from 2 mg to 5 mg, or 5 mg to 10 mg). Children will continue at 2, 5, or 10 mg Circadin® in an open-label period for another 78 weeks of follow-up, which will include continuous safety monitoring and 2 efficacy assessment time points at Weeks 41 and 54. The study will end with a 2-week SB placebo run-out period.
Each patient will participate in the study until the end of the second open-label safety follow-up period, and 2 week run-out period. The study duration will be 112 weeks, including the 4-week wash-out period with sleep hygiene and behavioral intervention.
- Conditions
- Sleep Disorders
- Being tested
- Circadin 2/5/10 mg, Placebo
- Keywords
- Sleep disturbance, Circadian, Prolong release melatonin, Autism Spectrum Disorder, Smith-Magenis Syndrome, Angelman Syndrome, tuberous sclerosis
- Medical subject headings
- Sleep Wake Disorders, Parasomnias, Autism Spectrum Disorder, Smith-Magenis Syndrome, Angelman Syndrome, Tuberous Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circadin 2/5/10 mgDrug
Also called Active arm
Circadin 2/5/10 mg. Active arm
PlaceboDrug
Also called Control
Control arm
| Study group | Role | What they receive |
|---|---|---|
| Circadin 2/5/10 mg | Active comparator | Active arm Receives: Drug: Circadin 2/5/10 mg |
| Placebo | Placebo comparator | Placebo arm Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Sleep Time (TST)
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
Measured: 13 weeks
Secondary outcomes (13)
Sleep Latency (Mins)
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.
Measured: 13 weeks
Duration of Wake After Sleep
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.
Measured: 13 weeks
Number of Awakenings Per Night
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.
Measured: 13 weeks
Longest Sleep Period
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.
Measured: 13 weeks
Social Functioning - Children Global Assessment Scale (CGAS)
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.
Measured: 13 weeks
Behavior at Home and in School - Strengths and Difficulties Questionnaire (SDQ)
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.
Measured: 13 weeks
Number of Dropouts
Number of dropouts during the 13 weeks of double-blind treatment in the Circadin 2/5 mg and placebo arms.
Measured: 13 weeks
Assessment of Sleep Parameters by Actigraphy
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.
Measured: 13 weeks
Safety and Tolerability - Treatment Emergent Signs and Symptoms (TESS) Summary.
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.
Measured: 13 weeks, 26 weeks, 52 weeks.
Safety and Tolerability - Blood Pressure (mmHg)
Systolic and Diastolic Blood Pressure (mmHg) A normal blood pressure (BP) level is lower than 140/70 mmHg, meaning systolic BP values lower than 140 mmHg, and diastolic BP values lower than 70 mmHg.
Values within the normal range mean good safety and tolerability outcomes.
Measured: 13 weeks, 26 weeks, 52 weeks.
Safety and Tolerability - Pulse (Beats Per Minute)
Safety and tolerability of Circadin treatment compared to placebo: Pulse rate. The normal pulse for healthy adults ranges from 60 to 100 beats per minute (bpm).
Values within the normal range mean good safety and tolerability outcomes.
Measured: 13 weeks, 26 weeks, 52 weeks.
Safety and Tolerability - Respiratory Rate (Bpm)
Respiratory rate (breaths per minute). The normal respiratory rate for elderly individuals living independently is 12-18 breaths per minute while it is 16-25 breaths per minute for those needing long-term care.
Values within the normal range mean good safety and tolerability outcomes.
Measured: 13 weeks, 26 weeks, 52 weeks.
Safety and Tolerability - Body Temperature (°C)
Body Temperature (°C). Normal body temperature varies by person, age, activity, and time of day. It ranges from 36.1°C to 37.2°C.
Values within the normal range mean good safety and tolerability outcomes.
Measured: 13 weeks, 26 weeks, 52 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2013 (estimated)
- Study startOct 2013
- Primary completion27 Mar 2018
- Study completion27 Mar 2018
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 (2)Papers the sponsor has linked to this study.
- Other trials for Sleep DisordersStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurim Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Gringras, PhD, Principal investigator, Thoma's Hospital, Westminster Bridge Rd, LondonRobert Findling, MD, Principal investigator, Kennedy Krieger Institute, Baltimore, Maryland, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01906866
- Sponsor's protocol ID
- NEU_CH_7911
- Status last verified
- Apr 2024
- First submitted
- 11 Jul 2013
- Last updated
- 23 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Malow BA, Findling RL, Schroder CM, Maras A, Breddy J, Nir T, Zisapel N, Gringras P. Sleep, Growth, and Puberty After 2 Years of Prolonged-Release Melatonin in Children With Autism Spectrum Disorder. J Am Acad Child Adolesc Psychiatry. 2021 Feb;60(2):252-261.e3. doi: 10.1016/j.jaac.2019.12.007. Epub 2020 Jan 23.
PubMed 31982581Gringras P, Nir T, Breddy J, Frydman-Marom A, Findling RL. Efficacy and Safety of Pediatric Prolonged-Release Melatonin for Insomnia in Children With Autism Spectrum Disorder. J Am Acad Child Adolesc Psychiatry. 2017 Nov;56(11):948-957.e4. doi: 10.1016/j.jaac.2017.09.414. Epub 2017 Sep 19.
PubMed 29096777
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled Study to Investigate the Efficacy and Safety of Circadin® to Alleviate Sleep Disturbances in Children With Neurodevelopmental Disabilities
- ClinicalTrials.gov ID
- NCT01906866
- Acronym / sponsor ID
- NEU_CH_7911
- Conditions
- Sleep Disorders
- Keywords
- Sleep disturbance, Circadian, Prolong release melatonin, Autism Spectrum Disorder, Smith-Magenis Syndrome, Angelman Syndrome, tuberous sclerosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Neurim Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- 27 Mar 2018 (actual)
- Study completion
- 27 Mar 2018 (actual)
- First posted
- 24 Jul 2013 (estimated)
- Results
- Posted 30 Oct 2018
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 study is to establish the efficacy and safety of Circadin in children with neurodevelopmental disorders and to determine the dose, this randomized, placebo-controlled study is planned to evaluate the efficacy of a double-blind, 13 week treatment period with Circadin 2/5mg in improving maintenance of sleep, sleep latency and additional parameters in children with neurodevelopmental disabilities. The efficacy and safety of Circadin 2/5 mg will continue to be assessed during an open-label extension period of 13 weeks.
Detailed description
This is a randomized placebo-controlled study in children diagnosed with autism spectrum disorders (ASDs) and neurodevelopmental disabilities caused by neurogenetic diseases.
Children who are found to be eligible for the study will follow a 4-week, basic sleep hygiene and behavioral intervention wash-out period, and will continue in a 2-week single-blind (SB) placebo run-in period. Then, they will be randomized in a 1:1 ratio to receive either Circadin® 2 mg or placebo for 3 weeks in a double-blind treatment period.
After 3 weeks of treatment, on the last day of Week 5 ±3 days (Visit 3), sleep variables will be assessed to determine if dose modification (an increase to 5 mg) is required. Children will then continue on 2 or 5 mg of Circadin® or placebo for an additional double-blind period of 10 weeks. This double-blind period will be followed by an open-label period of 13 weeks. At the end of the 13-week open-label period on the last day of Week 28 ±3 days (Visit 5), sleep variables will be assessed to determine if a potential additional dose modification (i.e., an increase either to 5 mg for patients who are still on 2 mg or an increase to 10 mg for patients who are on 5 mg) is necessary (If a dose increase is decided upon, the dose increase should be from 2 mg to 5 mg, or 5 mg to 10 mg). Children will continue at 2, 5, or 10 mg Circadin® in an open-label period for another 78 weeks of follow-up, which will include continuous safety monitoring and 2 efficacy assessment time points at Weeks 41 and 54. The study will end with a 2-week SB placebo run-out period.
Each patient will participate in the study until the end of the second open-label safety follow-up period, and 2 week run-out period. The study duration will be 112 weeks, including the 4-week wash-out period with sleep hygiene and behavioral intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Circadin 2/5/10 mg | Active comparator | Drug: Circadin 2/5/10 mgActive arm |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo arm |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- To be eligible for study entry, all patients must satisfy all of the following criteria at screening:
- Must be children 2 to 17.5 years of age at Visit 2 who comply with taking the study drug
- Must have written informed consent provided by a legal guardian and assent (if needed)
- Must have a documented history of ASD according to or consistent with the ICD-10 (International Classification of Diseases) or DSM-5/4 (Diagnostic and Statistical Manual of Mental Disorders) criteria, or neurodevelopmental disabilities caused by neurogenetic diseases (i.e., Smith-Magenis syndrome, Angelman syndrome, Bourneville's disease [tuberous sclerosis]) as confirmed by case note review showing that diagnosis was reached through assessment by a community pediatrician or pediatric neurologist or other health care professionals experienced in the diagnosis who took into account early developmental history and school records.
- Must have current sleep problems including: a minimum of 3 months of impaired sleep defined as ≤6 hours of continuous sleep AND/OR ≥0.5 hour sleep latency from light off in 3 out of 5 nights based on parent reports and patient medical history. (The maintenance and latency problems do not necessarily have to be in the same 3 nights of the week.)
Key exclusion criteria (11 listed)
- Children who meet any of the following criteria will be excluded from participating in the study:
- Have had treatment with any form of melatonin within 2 weeks prior to Visit 1
- Have a known allergy to melatonin or lactose
- Have a known moderate to severe sleep apnea
- Have an untreated medical/ineffectively treated/psychological condition that may be the etiology of sleep disturbances
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 |
|---|---|---|
| Circadin 2/5/10 mgAlso: Active armCircadin 2/5/10 mg. Active arm | Drug | Circadin 2/5/10 mg |
| PlaceboAlso: ControlControl arm | Drug | Placebo |
Primary outcome
Total Sleep Time (TST)
Time frame: 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
13 secondary outcomes
Sleep Latency (Mins)
Time frame: 13 weeks
Duration of Wake After Sleep
Time frame: 13 weeks
Number of Awakenings Per Night
Time frame: 13 weeks
Longest Sleep Period
Time frame: 13 weeks
Social Functioning - Children Global Assessment Scale (CGAS)
Time frame: 13 weeks
Behavior at Home and in School - Strengths and Difficulties Questionnaire (SDQ)
Time frame: 13 weeks
Number of Dropouts
Time frame: 13 weeks
Assessment of Sleep Parameters by Actigraphy
Time frame: 13 weeks
Safety and Tolerability - Treatment Emergent Signs and Symptoms (TESS) Summary.
Time frame: 13 weeks, 26 weeks, 52 weeks.
Safety and Tolerability - Blood Pressure (mmHg)
Time frame: 13 weeks, 26 weeks, 52 weeks.
Safety and Tolerability - Pulse (Beats Per Minute)
Time frame: 13 weeks, 26 weeks, 52 weeks.
Safety and Tolerability - Respiratory Rate (Bpm)
Time frame: 13 weeks, 26 weeks, 52 weeks.
Safety and Tolerability - Body Temperature (°C)
Time frame: 13 weeks, 26 weeks, 52 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31982581Malow BA, Findling RL, Schroder CM, Maras A, Breddy J, Nir T, Zisapel N, Gringras P. Sleep, Growth, and Puberty After 2 Years of Prolonged-Release Melatonin in Children With Autism Spectrum Disorder. J Am Acad Child Adolesc Psychiatry. 2021 Feb;60(2):252-261.e3. doi: 10.1016/j.jaac.2019.12.007. Epub 2020 Jan 23.
- Derived from this study: PubMed 29096777Gringras P, Nir T, Breddy J, Frydman-Marom A, Findling RL. Efficacy and Safety of Pediatric Prolonged-Release Melatonin for Insomnia in Children With Autism Spectrum Disorder. J Am Acad Child Adolesc Psychiatry. 2017 Nov;56(11):948-957.e4. doi: 10.1016/j.jaac.2017.09.414. Epub 2017 Sep 19.
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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.
Paul Gringras, PhD principal investigator
Thoma's Hospital, Westminster Bridge Rd, London
Robert Findling, MD principal investigator
Kennedy Krieger Institute, Baltimore, Maryland, USA
28 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Circadin 2/5/10 mg in people with Sleep Disorders, run by Neurim Pharmaceuticals Ltd. at 28 sites in 5 countries.
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 11 inclusion and 11 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 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, United Kingdom, Netherlands, France, Finland. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 30 Oct 2018). 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?
Total Sleep Time (TST) (time frame: 13 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 NCT01906866, which also lists 2 linked publications.
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 23 Apr 2024.