Clinical trials: Sleep Disorders in Children
Sleep Problems
Assessment of the Pharmacokinetics of Circadin® in Children With Neurodevelopmental Disorders and Sleep Disturbances
There is increasing evidence that chronic sleep disorders in children with autism spectrum disorder (ASD), Angelman Syndrome (AS) and Smith-Magenis syndrome (SMS) are associated with disturbed melatonin secretion and melatonin…
- Trial name
- NCT01903681
- Testing
- Circadin 2 mg, Circadin 10 mg
- Where
- Netherlands
- Volunteers
- 16 people
- Sponsor
- Neurim Pharmaceuticals Ltd.
Narcolepsy
Study of PROVIGIL ® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy
Primary Objectives: The primary objectives of the study are to determine the effectiveness of PROVIGIL treatment, compared to placebo treatment, in children and adolescents with excessive sleepiness (ES) associated with…
- Trial name
- NCT00107796
- Testing
- Modafinil
- Where
- 73 sites in United States, Canada
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Cephalon
Restless Legs Syndrome
Dose Escalating Study of Rotigotine in Pediatric Subjects With Restless Legs Syndrome
This was a multicenter, open-label, dose-escalation, Phase 2A study with multiple administrations of the rotigotine transdermal system.
- Trial name
- NCT01495793
- Testing
- Rotigotine
- Where
- 12 sites in United States
- Volunteers
- 42 people
- Sponsor
- UCB BIOSCIENCES, Inc.
Sleep Initiation and Maintenance Disorders
Single Dose Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Evaluation of Eplivanserin in Children With Insomnia
Given the potential age-related differences in safety, tolerability, pharmacokinetics, and differences in sleep architecture in young children versus adolescent versus adult, studies to identify the appropriate drug and dosage…
- Trial name
- PKiDs (NCT00913614)
- Testing
- Eplivanserin (SR46349)
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- Sanofi
Pregnancy Related, Narcolepsy
WAKIX® (Pitolisant) Pregnancy Registry
The WAKIX (pitolisant) Pregnancy Registry is a US-based, prospective, observational cohort study designed to evaluate the association between pitolisant exposure during pregnancy and subsequent maternal, fetal, and infant…
- Trial name
- NCT05536011
- Testing
- Pitolisant, Comparator Products
- Where
- United States
- Volunteers
- 1,329 people
- Sponsor
- Harmony Biosciences Management, Inc.
Autism Spectrum Disorder, Sleep Disorder
Evaluating the Effects of Tasimelteon in Individuals With Autism Spectrum Disorder (ASD) and Sleep Disturbances
This is a multicenter, open-label study to evaluate the efficacy and safety of a daily single oral dose of tasimelteon in treating sleep disturbances in pediatric and adult participants with ASD.
- Conditions
- Autism Spectrum Disorder, Sleep Disorder, Neurological Disorder, Sleep Disturbance
- Trial name
- NCT05361707
- Testing
- Tasimelteon Oral Capsule, Tasimelteon Liquid Suspension
- Where
- 5 sites in United States
- Volunteers
- 100 people
- Sponsor
- Vanda Pharmaceuticals
Narcolepsy, Obstructive Sleep Apnea
SUNOSI® (Solriamfetol) Pregnancy Registry
The SUNOSI (solriamfetol) Pregnancy Registry is a US- and Canada-based prospective, observational study to evaluate the safety of solriamfetol exposure during pregnancy in women with a diagnosis of narcolepsy or obstructive sleep…
- Conditions
- Narcolepsy, Obstructive Sleep Apnea, Pregnant Women and Their Offspring
- Trial name
- NCT06413420
- Testing
- Sunosi (solriamfetol), Other prescription wake-promoting medications or stimulants, No treatment
- Where
- 2 sites in United States
- Volunteers
- 1,731 people
- Sponsor
- Axsome Therapeutics, Inc.