MENDS: The use of MElatonin in children with Neuro-developmental Disorders and impaired Sleep; a randomised, double-blind, placebo-controlled, parallel study - MENDS

Phase 1

• Conditions: children with neuro-developmental disorders and impaired sleep; MedDRA version: 9.1Level: PTClassification code 10064062Term: Neurodevelopmental disorder; MedDRA version: 9.1Level: PTClassification code 10040984Term: Sleep disorder

• Registration Number: EUCTR2006-004025-28-GB
• Lead Sponsor: Royal Liverpool Children’s NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05-16
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Children aged 3 years to 15 years 8 months at screening.
2.Diagnosis of a neuro-developmental disorder that has been made by a community paediatrician, paediatric neurologist or paediatric neurodisability consultant, categorised as:
a.developmental delay alone
b.developmental delay and epilepsy*
c.developmental delay and autistic spectrum disorder* (ASD)
d.developmental delay with ‘other’ (‘other’ is defined as the child having a specific genetic/chromosomal disorder).
or any combination of the above.
3.Adaptive Behaviour Assessment System (ABAS) questionnaire score with a percentile rank below 7.
4.Minimum 5 months history of impaired sleep at screening as defined by:
a.not falling asleep within one hour of 'lights off' or 'snuggling down to sleep' at age-appropriate times for the child**, and/or:
b.less than 6 hours of continuous sleep in three nights out of five
5.Children whose parents are likely to be able to use the actigraph and complete sleep diaries
6.Children who are able to comply with taking the study drug
7.English speaking
8.Children whose parents have completed sleep diaries for an average of 5 out of 7 nights at T0W.

* In coding the presence of epilepsy and ASD diagnoses, we will require sight of documentation from relevant services that demonstrate appropriate diagnostic assessments and investigations have been used
** This will be the child’s usual bedtime (recorded in the sleep diary) based upon the family’s normal routine

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Children treated with melatonin within 5 months prior to screening
2.Any plans to commence the following medication:
•any benzodiazepines
•amisulpride (Solian)
•chlorpromazine (Largactil)
•haloperidol (Haldol)
•olanzapine (Zyprexa)
•risperidone (Risperdal)
•sertindole (Serdolect)
•sulpiride (Sulpidil, Sulpor)
•thioridazine (Melleril)
•trifluoperazine (Stelazine)
3.Current use of beta blockers (minimum of 7 days washout required)
4.Current use of sedative or hypnotic drugs, including Choral hydrate, Triclofos and alimemazine tartrate (Vallergan) (minimum of 14 days washout required)
5.Children with a known allergy to melatonin
6.Regular consumption of alcohol (> 3 times per week)
7.Children for whom there are suggestive symptoms of Obstructive Sleep Apnoea Syndrome (OSAS) (such as combinations of snoring, gasping, excessive sweating or stopping breathing during sleep), physical signs supportive of OSAS (such as very large tonsils/very small chin), or results of investigations suggesting OSAS (such as overnight pulse oximetry or polysomnography) for which the child should be referred to appropriate respiratory or ENT colleagues for specific assessment and treatment
8.Girls or young women who are pregnant at the time of screening (T– 4W)
9.Currently participating in a conflicting clinical study or participation in a clinical study involving a medicinal product within the last 3 months

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified