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

Completed · Phase 3 · Has a placebo group

Conditions studied: Sleep Disorders

In brief

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.

Key facts

Study ID

NCT01906866

Run by

Neurim Pharmaceuticals Ltd.

People needed

125

Starts

2013-10-01

Expected to finish

2018-03-27

Last updated by the study team

2024-04-23

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)
• 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

You may not qualify if…

• 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
• 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

Where it is running

• Southwest Autism Research and Resource Center (SARRC) — Phoenix, Arizona, United States
• Crystal BioMedical Research, LLC — Miami Lakes, Florida, United States
• Lake Mary Pediatrics — Orange City, Florida, United States
• Mate Lazlo — West Palm Beach, Florida, United States
• Attalla Consultants LLC, dba Institue for Behabiovral medicine — Smyrna, Georgia, United States
• AMR Baber research INC — Naperville, Illinois, United States
• Kennedy Krieger Institute — Baltimore, Maryland, United States
• Child Neurology Specialists/ CRCN — Henderson, Nevada, United States
• Clinical research center of New Jersey, LLC — Voorhees Township, New Jersey, United States
• Geinsinger Clinic — Danville, Pennsylvania, United States
• The children's hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Vanderbilt University — Nashville, Tennessee, United States
• INSITE Clinical Research — DeSoto, Texas, United States
• Red Oak Psychiatry Associates — Houston, Texas, United States
• Sleep Therapy & Research Center — San Antonio, Texas, United States
• Road Runner Research, Ltd — San Antonio, Texas, United States
• Ericksen Research & Development — Clinton, Utah, United States
• Pacific institute of medical science — Bothell, Washington, United States
• Helsinki Sleep Clinic Vitalmed OY — Helsinki, Finland
• Hospital Raymond Poincare — Garches, France
• Strasbourg University Hospital Depatment of Child Psychiatry & Neurology — Strasbourg, France
• Yulius Mental Health Organization — Dordrecht, Netherlands
• Hospital Gelderse Vallei — Ede, Netherlands
• University Medical Center Groningen — Groningen, Netherlands
• Birmingham Childrens Hospital NHS FOUNDATION TRUST — Birmingham, United Kingdom

Full record on ClinicalTrials.gov

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