Evaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia

Conditions

• Insomnia Disorder

Eligibility Criteria

Sex

ALL

Age

2 Years - 17 Years

Healthy Volunteers

Not accepted

Interventions

• Tasimelteon Oral Suspension — DRUG
  Single daily dose, weight-based liquid suspension formulation.
• Placebo — DRUG
  Placebo comparator.

Study Details

This is a multicenter, double-blind, randomized study to evaluate the efficacy and safety of a daily single oral dose of tasimelteon and matching placebo in male and female pediatric participants with insomnia disorder.

Key Dates

Start date

Apr 21, 2025

Status verified

Jun 2026

Primary completion

Nov 30, 2027

Completion

Jan 31, 2028

Study Design

Enrollment

420 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Tasimelteon
• Placebo Comparator: Placebo

Primary Outcome Measure

Change in sleep latency, as measured by daily sleep diary. [ Time Frame: 12 Weeks ]

Central Contacts

• Vanda Pharmaceuticals, Inc.
  202-734-3400
  [email protected]

Locations (21)

Find similar trials in Dothan, AL

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