EUCTR2006-004025-28-GB进行中（未招募）1 期
MENDS: The use of MElatonin in children with Neuro-developmental Disorders and impaired Sleep; a randomised, double-blind, placebo-controlled, parallel study - MENDS
Royal Liverpool Children’s NHS Trust0 个研究点开始时间: 2007年5月16日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
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