Status:
COMPLETED
Efficacy and Safety of Circadin® in the Treatment of Sleep Disturbances in Children With Neurodevelopment Disabilities
Lead Sponsor:
Neurim Pharmaceuticals Ltd.
Conditions:
Sleep Disorders
Eligibility:
All Genders
2-17 years
Phase:
PHASE3
Brief 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 plan...
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 t...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 27 2018
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT01906866
Start Date
October 1 2013
End Date
March 27 2018
Last Update
April 23 2024
Active Locations (28)
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1
Southwest Autism Research and Resource Center (SARRC)
Phoenix, Arizona, United States, 85006
2
Crystal BioMedical Research, LLC
Miami Lakes, Florida, United States, 33014
3
Lake Mary Pediatrics
Orange City, Florida, United States, 32763
4
Mate Lazlo
West Palm Beach, Florida, United States, 33408