Replies to post #234 on Axsome Therapeutics Inc (AXSM)

[smallbio]

This is the current AXS-12 p2 study info.

https://clinicaltrials.gov/ct2/show/NCT03881852

Study Design:
Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Double-blind, Placebo-controlled, 3-Week Crossover Study to Assess the Efficacy and Safety of AXS-12 in Subjects With Cataplexy and Excessive Daytime Sleepiness in Narcolepsy
Actual Study Start Date : January 30, 2019
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Outcome Measurement
1) Primary Outcome Measures :
Number of cataplexy attacks [ Time Frame: Change from Baseline to end of Week 2 (Period 1) and Week 5 (Period 2) ]

Secondary Outcome Measures :
1) Epworth Sleepiness Scale (ESS) [ Time Frame: Change from Baseline to end of Week 2 (Period 1) and Week 5 (Period 2) ]
The ESS is a patient-reported questionnaire consisting 8 questions. Each of the items are rated on a 4-point scale (0-3), based on the usual chances of dozing off or falling asleep while engaged in eight different activities. The total ESS score can range from 0 to 24.

2) Maintenance of Wakefulness Test (MWT) [ Time Frame: Change from Baseline to end of Week 2 (Period 1) and Week 5 (Period 2) ]