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Clinical Trials/2024-516411-24-00
2024-516411-24-00
Not yet recruiting
Phase 3

A MULTICENTER, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE THE EFFECTS OF TASIMELTEON VS. PLACEBO IN TREATING PEDIATRIC INSOMNIA

Vanda Pharmaceuticals Netherlands B.V., Vanda Pharmaceuticals Inc.2 sites in 2 countries50 target enrollmentStarted: September 23, 2025Last updated:
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Overview

Phase
Phase 3
Status
Not yet recruiting
Sponsor
Vanda Pharmaceuticals Netherlands B.V., Vanda Pharmaceuticals Inc.
Enrollment
50
Locations
2
Primary Endpoint
Sleep Latency as measured by daily sleep diary
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

To evaluate the efficacy of tasimelteon administered daily compared to placebo on Sleep Latency in participants, as measured by daily diary.

Study Design

Allocation
Not Applicable
Primary Purpose
Open-Label Extension Phase
Masking
None

Eligibility Criteria

Ages
0 years to 17 years (0-17 Years)
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •A confirmed clinical diagnosis of insomnia disorder as per DSM-V or ICSD-3 criteria.
  • •Reported sleep latency of ≥ 1 hour on average 4 nights/week for at least 3 months prior to screening (For PK sub-study, only reported sleep complaint 4 nights/week is required).
  • •Sleep latency of ≥ 1 hour on average 4 nights/week and at least 3 nights/week in each of the 4 weeks preceding randomization by sleep diary (Not required for PK sub-study).
  • •The sleep disturbance must not be a result of another medication.
  • •Male or female between 2 and 17 years of age, inclusive, at Visit 1 (V1).
  • •Informed consent from the legal guardian (and assent, as required).
  • •Completing the required Daily Sleep Diary for an average of 5 out of 7 nights during screening.
  • •Both guardian and child are willing and able to comply with study requirements and restrictions.

Exclusion Criteria

  • •Use of prohibited medications (as detailed in Section 9.2.1 clinical Study Protocol).
  • •Previous intolerance to tasimelteon.
  • •Unable to dose daily with medication.
  • •Pregnant or breastfeeding females.
  • •A positive test for drugs of abuse.
  • •Exposure to any investigational drug, including placebo, within 30 days or 5 half-lives (whichever was longer) of screening.
  • •Unwilling or unable to follow the medication restrictions including the washout from use of a prohibited medication.
  • •Any other sound medical reason as determined by the clinical investigator or the sponsor.

Outcomes

Primary Outcomes

Sleep Latency as measured by daily sleep diary

Sleep Latency as measured by daily sleep diary

Secondary Outcomes

  • 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

Investigators

Sponsor
Vanda Pharmaceuticals Netherlands B.V., Vanda Pharmaceuticals Inc.
Sponsor Class
Pharmaceutical company, Pharmaceutical company
Responsible Party
Principal Investigator
Principal Investigator

Christos Polymeropoulos

Scientific

Vanda Pharmaceuticals Netherlands B.V.

Study Sites (2)

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