FindTrial
Sign In

OPEN-LABEL SAFETY STUDY OF A 1-YEAR 20MG DOSE REGIMEN OF TASIMELTEON FOR THE TREATMENT OF NON-24-HOUR SLEEP-WAKE DISORDER (N24HSWD) IN BLIND INDIVIDUALS WITH NO LIGHT PERCEPTION

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516721-31-00
Acronym
VP-VEC-162-3202
Enrollment
140
Registered
2024-12-03
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-24 Hour Sleep-Wake Disorder

Brief summary

Adverse events (AEs) including suicidal ideation or behavior, changes in vital signs, clinical laboratory evaluations, electrocardiograms (ECGs) and physical exam findings during treatment.

Detailed description

Patient Global Impression-Change (PGI-C) for nighttime sleep., Patient Global Impression-Change (PGI-C) for daytime naps., Clinical Global Impression-Change (CGI-C).

Interventions

DRUGTASIMELTEON
DRUGHETLIOZ 20 mg hard capsules

Sponsors

Vanda Pharmaceuticals Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Adverse events (AEs) including suicidal ideation or behavior, changes in vital signs, clinical laboratory evaluations, electrocardiograms (ECGs) and physical exam findings during treatment.—

Secondary

MeasureTime frame
Patient Global Impression-Change (PGI-C) for nighttime sleep., Patient Global Impression-Change (PGI-C) for daytime naps., Clinical Global Impression-Change (CGI-C).—

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026