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Vanda Announces Positive Results in the Second Phase III Study (RESET) of Tasimelteon for the Treatment of Non-24-Hour Disorder
Date:1/23/2013

quality of life for individuals with Non-24."

RESET Study Results SummaryPrimary Endpoint  The RESET study was a 20 patient randomized withdrawal study designed to demonstrate the maintenance effect of 20mg of tasimelteon in the treatment of blind individuals with Non-24.
Patients were treated with tasimelteon for three months during an open-label run-in phase.  Patients who responded to tasimelteon treatment during the run-in phase, as measured by entrainment of the melatonin rhythm (aMT6s) to the 24-hour day, were then randomized to receive either placebo or continue receiving tasimelteon 20mg for 2 months.  The primary endpoint of the study was the maintenance of effect as measured by entrainment of the melatonin (aMT6s) rhythm.

Primary Endpoint ResultsTasimelteon

 

Placebo

 

p-value

 Maintenance of entrainment (aMT6s) (%)

90.0

20.0

0.0026Secondary Endpoints  The RESET study also assessed a number of secondary endpoints including maintenance of entrainment of the cortisol rhythm and a range of sleep and wake parameters including LQ-nTST (total nighttime sleep in the worst 25% of nights), UQ-dTSD (total daytime sleep duration in the worst 25% of days) and MoST (midpoint of sleep timing from both nighttime and daytime sleep). 

Secondary Endpoint ResultsTasimelteon

 

Placebo

 

Difference

 

p-value

 Maintenance of entrainment (cortisol) (%)

80.0

20.0

60.0

0.0118LQ-nTST (LS mean minutes)1

-6.6

-73.8

67.2

0.0233UQ-dTSD (LS mean minutes)2

-9.6

49.8

-59.4

0.0266MoST (LS mean minutes)1

19.8

-16.2

36.0

0.01081) Higher number indicates improvement2) Lower number indicates improvementFrom the run-i
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SOURCE Vanda Pharmaceuticals Inc.
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