Insomnia Disorder
Conditions
Brief summary
Sleep Latency as measured by daily sleep diary
Detailed description
Nighttime subjective sleep parameters as measured by daily sleep diary, Patient Global Impression of Change scale (PGI-C), Clinical Global Impression of Change scale (CGI-C), Caregiver Global Impression of Change scale (CaGI-C), Epworth Sleepiness Scale for Children and Adolescents (ESS-CHAD), Sheehan Disability Scale for Pediatrics and Adolescents (SDS-P/A), Aberrant Behavior Checklist (ABC), Actigraphy parameters, Tasimelteon pharmacokinetics (PK) in 2-year-old participants
Interventions
DRUGPlacebo liquid formulation will be indistinguishable from its tasimelteon counterpart and will be administered in the same way.
DRUGTasimelteon
Sponsors
Vanda Pharmaceuticals Netherlands B.V., Vanda Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleep Latency as measured by daily sleep diary | — |
Secondary
| Measure | Time frame |
|---|---|
| Nighttime subjective sleep parameters as measured by daily sleep diary, Patient Global Impression of Change scale (PGI-C), Clinical Global Impression of Change scale (CGI-C), Caregiver Global Impression of Change scale (CaGI-C), Epworth Sleepiness Scale for Children and Adolescents (ESS-CHAD), Sheehan Disability Scale for Pediatrics and Adolescents (SDS-P/A), Aberrant Behavior Checklist (ABC), Actigraphy parameters, Tasimelteon pharmacokinetics (PK) in 2-year-old participants | — |
Countries
Germany, Poland
Outcome results
None listed