Trial intelligence / Profile preview

Tasimelteon for Sleep Disturbances in Smith-Magenis Syndrome

NCT02231008Phase 3Completed

Sponsor
Vanda Pharmaceuticals Inc.
Start
Sep 2015
Primary completion
Nov 2018
Modality
Small Molecules
Countries
1
01

Overview

Phase 3, randomised, triple-blind trial in Smith-Magenis syndrome (SMS) comparing Tasimelteon with Placebo (2 arms). Primary endpoints: Daily Diary Sleep Quality (50% worst nights) at 9 weeks and Daily Diary Total Nighttime Sleep Duration (50% worst nights) at 9 weeks. Started Sep 2015; status: completed.

02

Drugs

tasimelteon
03

Conditions

Smith-Magenis syndrome (SMS)

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