CompletedPhase 3

Efficacy and Safety of Tasimelteon Compared With Placebo in Totally Blind Subjects With Non-24-Hour Sleep-Wake Disorder

United States136 participantsStarted 2010-08

Plain-language summary

The purpose of this study is to evaluate the efficacy and safety of a six month double-mask treatment of tasimelteon or placebo in male and female subjects with Non-24-Hour Sleep-Wake Disorder

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. History (within the last 3 months) of trouble sleeping at night difficulty initiating sleep or staying asleep), difficulty awakening in the morning, or daytime sleepiness as determined by answering yes to at least one question in the Sleep Complaint Questionnaire and
✓. Urinary aMT6s demonstrates a progressive delay of the aMT6 acrophase time.

What they're measuring

Proportion of Patients Entrained as Assessed by Urinary aMT6

Timeframe: 1 month

Proportion of Patients With a Clinical Response: Entrainment of aMT6 and Score of ≥ 3 on N24CRS

Timeframe: 6 months

Trial details

NCT IDNCT01163032

SponsorVanda Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-11

Results submitted2014-08-08

View on ClinicalTrials.gov More Non-24-Hour Sleep-Wake Disorder trials