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NCT01218789Phase 3ACTIVE NOT RECRUITING

Safety Study of Tasimelteon for Treatment of Non-24-Hour-Sleep-Wake Disorder in Blind Individuals With No Light Perception

Study Summary

The purpose of this study is to evaluate the safety of a one year open-label treatment of tasimelteon in male and female subjects with Non-24-Hour Sleep-Wake Disorder.

Conditions
Non 24 Hour Sleep Wake Disorder
Interventions / Drugs
tasimelteon
View on ClinicalTrials.gov ↗
Sponsor
VNDA
Vanda Pharmaceuticals
Neuroscience
D41/100
Study Details
Enrollment140 participants
Primary Completion—
Lead SponsorVanda Pharmaceuticals
Data Retrieved2026-04-11 04:31:05.188580+00:00
What This Trial Means for Biotech Investors
Trial Phase Context

Phase 3 trials are pivotal studies with large patient populations (hundreds to thousands) designed to prove efficacy and safety for FDA submission. A successful Phase 3 readout is typically the last major hurdle before a New Drug Application (NDA) or BLA filing.

Status & Expected Data

Enrollment is complete. The trial is in its follow-up or data collection phase — a readout may occur on or near the primary completion date.

Enrolled: 140 participants
Sponsor Catalyst Profile

Vanda Pharmaceuticals (VNDA) is the sponsoring company for this trial. BiotechSign currently grades this company D (41/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.

VNDA Full Pipeline →All Companies →
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